[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"acute-respiratory-distress-syndrome-ards\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:acute-respiratory-distress-syndrome-ards":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,44,0,25,[9,59,89,118,135,150,166,192,217,241,272,299,323,352,376,401,424,446,521,551,575,605,626,648,673],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":33,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":51,"completionDateStruct":53,"leadSponsor":55,"locationsCount":58},"100644735","personalized-ventilator-settings-for-patients-on-ecmo-100644735",false,"NCT07673250","Personalized Ventilator Settings for Patients on ECMO","Personalized Ventilator Settings for Patients on ECMO (PEEPECMO)","PEEPECMO","1. History of Lung or Cardiac Transplantation, or definite bridge to transplantation\n2. Patient is not committed to full support\n3. Treating clinician refusal, or unwillingness to commit to controlled therapeutics (Esophageal Pressure Guided Positive End-Expiratory Pressure and neuromuscular blockade)\n4. Inability to get informed consent from the patient or legally authorized representative (LAR)\n5. Patients with contraindications to esophageal balloon placement or inability to successfully place an esophageal balloon will have personalized PEEP determined by electrical impedance tomography.\n\n   a. Contraindications include recently treated or bleeding varices, esophageal stricture, hematemesis, esophageal trauma, recent esophageal surgery or other contraindication for nasogastric tube placement, or severe coagulopathy.\n6. Severe barotrauma that requires lower mean airway pressure (i.e., PEEP) per the treating physician.\n7. Patients who are pregnant or prisoners.\n8. Has been on V-V ECMO \\> 72 hours.","ALL","18 Years",{"count":21,"type":22},62,"ESTIMATED","INTERVENTIONAL",[25],"NA","While mechanical ventilation can be used to sustain life in those with lung injury, it, can further worsen lung injury or prevent lung healing resulting in high morbidity and mortality as seen in Acute Respiratory Distress Syndrome (ARDS).\n\nUsing extracorporeal membrane oxygenation (ECMO), the highest level of life support also known as the heart-lung machine, investigators may minimize injury from mechanical ventilation to allow the lungs to heal; however, the optimal ventilator strategies while on ECMO are unknown. This study will evaluate personalized ventilator strategy compared to standard of care ventilation.",[28,29,30,31,32],"Acute Respiratory Distress Syndrome (ARDS)","Extracorporeal Membrane Oxygenation","Respiratory Failure Patients Treated With ECMO","Respiratory Failure, ICU","Ventilator Induced Lung Injury",[34,35,36,37,38,39,40,41,42,43,44,45],"Respiratory failure","ARDS","Acute Respiratory Distress Syndrome","ECMO","Pneumonia","Lung injury","Influenza","COVID","Viruses","Personalized ventilator settings","Positive end expiratory pressure","PEEP","NOT_YET_RECRUITING","2026-08-03",{"date":49,"type":50},"2026-08-06","ACTUAL",{"date":52,"type":22},"2026-09-01",{"date":54,"type":22},"2031-06-30",{"name":56,"class":57},"University of California, San Diego","OTHER",1,{"id":60,"slug":61,"hasResults":12,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":4,"eligibilityCriteria":65,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":66,"targetDuration":4,"studyType":23,"phases":68,"briefSummary":69,"conditions":70,"keywords":72,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":58},"100643965","electrical-impedance-tomography-guided-identification-of-the-optimal-lateral-position-in-postoperative-ards-100643965","NCT07669558","Electrical Impedance Tomography-Guided Identification of the Optimal Lateral Position in Postoperative ARDS","Effect of Left Lateral, Right Lateral, and Supine Positioning on Ventilation-Perfusion Matching Assessed by Electrical Impedance Tomography in Adult Postoperative Abdominal Surgery Patients With ARDS: A Prospective Randomized Crossover Physiological Study","Inclusion Criteria:\n\n* Age ≥18 years\n* Postoperative abdominal surgery patients admitted to the ICU with ARDS (Berlin definition)\n* Considered able to tolerate protocolized position changes by the treating team\n* EIT belt placement and protocol procedures feasible\n* Informed consent obtained from the patient or legally authorized representative\n\nExclusion Criteria:\n\n* Contraindication to lateral positioning (e.g., unstable spine, uncontrolled bleeding, open abdomen, high-risk surgical wound condition)\n* Severe hemodynamic instability or other conditions making participation unsafe\n* High risk of airway\u002Fvascular line\u002Fdrain dislodgement not manageable\n* Pregnancy\n* Refusal of informed consent\n* Any other condition deemed inappropriate by investigators",{"count":67,"type":22},22,[25],"This prospective, randomized crossover physiological study evaluates the effects of lateral positioning (left lateral position and right lateral position) versus the supine position on ventilation-perfusion (V\u002FQ) matching in adult postoperative abdominal surgery participants with acute respiratory distress syndrome (ARDS). Bedside electrical impedance tomography (EIT) will be used to quantify regional ventilation and perfusion (perfusion derived from an intravenous tracer bolus administered during a brief breath-hold) and to calculate global \"normal V\u002FQ\" (normal V\u002FQ, %). Oxygenation, respiratory mechanics (when applicable), and hemodynamics will be recorded concurrently. Feasibility and safety of the positioning protocol will also be assessed.",[28,71],"Postoperative",[73,74,75,76,77,78,79],"acute respiratory distress syndrome (ARDS)","electrical impedance tomography (EIT","Lateral position","ventilation-perfusion","postoperative abdominal surgery","crossover study","supine position","RECRUITING","2026-07-30",{"date":47,"type":50},{"date":84,"type":50},"2026-06-28",{"date":86,"type":22},"2026-10-31",{"name":88,"class":57},"Ruijin Hospital",{"id":90,"slug":91,"hasResults":12,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":4,"eligibilityCriteria":95,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":96,"targetDuration":4,"studyType":23,"phases":98,"briefSummary":100,"conditions":101,"keywords":103,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":117},"100570117","phase-2-just-breathe-breathing-life-into-innovative-therapies-for-ards-master-record-100570117","NCT06703073","JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS (Master Record)","Phase 2 Clinical Platform Trial Investigating Multiple Therapeutic Options for the Treatment of Hospitalized Patients With Acute Respiratory Distress Syndrome (ARDS)","Inclusion Criteria\n\nEach participant must meet all of the following criteria to be enrolled in this study:\n\n* Participant (or their Legally Authorized Representative (LAR)) provides informed consent and agrees to comply with protocol requirements\n* Participant is at least 18 years of age or older at the time of consent.\n* Participant with signs and symptoms of ARDS according to the Berlin definition of ARDS.\n\nNote that participants on noninvasive ventilation may be screened.\n\n* Participant of childbearing potential must agree to either abstinence or use at least one primary form of contraception, not including hormonal contraception, from the time of screening through Day 28. Additional cohort-specific requirements may apply\n* Participant agrees to not participate in another investigational interventional study while participating in this study (i.e., through Day 90).\n\nExclusion Criteria\n\nParticipants will be excluded from the study if any of the following apply:\n\n* Participant with ARDS or at risk of developing ARDS due to the following reasons: trauma, large volume aspiration, or transfusion.\n* Participant with pulmonary edema due to cardiogenic pulmonary edema\u002Ffluid overload or hypoxemia primarily attributable atelectasis, in the absence of a predisposing risk factor for ARDS.\n* Participant who demonstrates an improvement in oxygenation and ventilatory support 24 hours prior to or during screening up to randomization, such that per investigator clinical judgement, the participant is expected to have significant improvement in lung function over subsequent 24 hours regardless of additional interventions.\n* Participant is known to be pregnant, nursing, or with a positive (urine and\u002For serum test) pregnancy test.\n* Participant is anticipated to be transferred to another hospital which is not a study site within 72 hours.\n* Participant is not expected to survive for 72 hours.\n* Participant has been on invasive mechanical ventilation or ECMO for ARDS for more than 48 hours for ARDS at the time of consent.\n* Participant has an underlying clinical condition where, in the opinion of the Investigator and based on their clinical judgement, it would be extremely unlikely that the participant would come off ventilation\n* Participant has severe COPD requiring continuous long-term home oxygen therapy or mechanical ventilation (noninvasive ventilation or via tracheotomy) except for CPAP or bi-level positive airway pressure used solely for sleep-disordered breathing.\n* Participant has interstitial lung disease or idiopathic pulmonary fibrosis requiring continuous chronic home oxygen therapy.\n* Participant has NY Heart Association Class IV congestive heart failure.\n* Participant has a known allergy to any study medication or any of its excipients.\n* Participant is receiving systemic immunosuppressive therapy for solid organ or hematopoietic cancer or transplant anti-rejection medication therapy OR systemic immunosuppressive corticosteroids (prednisone ≥20 mg daily or equivalent). NOTE: Patients onreceiving chronic low dose immunosuppressive therapy may be enrolled(e.g., prednisone \\\u003C20 mg\u002Fday or equivalent) and patients on stable, long-term maintenance immunosuppression (e.g., tacrolimus, mycophenolate, orsirolimus) and patients receiving physiologic replacement and hormonal therapies for breast cancer (e.g., tamoxifen, letrozole) or prostate cancer (leuprolide, bicalutamide) for \\>60 days may be eligible at the investigator's discretion of the investigator in consultation with the medical monitor.\n* Participant is receiving ongoing cytotoxic chemotherapy (IV or oral), OR combination targeted\u002Fimmunotherapy regimens for cancer within the past 60 days. Note: Participants receiving non-myelosuppressive cancer therapy (e.g., hormonal therapy or selected targeted \u002F immunotherapy regimens) may be eligible if therapy has been stable ≥60 days; The use of hydroxyurea to manage patients with chronic myeloid leukemia, polycythemia vera, essential thrombocythemia or sickle cell disease is permitted.\n* Participant received treatment with an investigational immunomodulator or immunosuppressant drugs within 5 half-lives or 30 days (whichever is longer) before randomization.\n* Participant with concurrent infections or history of the following:\n\n  1. Known active tuberculosis,\n  2. Known active Hepatitis B, or\n  3. HIV and a CD4 count less than 50 or a detectable viral load of \\>200 copies\u002FmL HIV RNA.\n* Participant received treatment with any other investigational drugs within 30 days prior to consent.\n* Participant had a history of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess within 28 days of screening or inadequate wound healing secondary to major thoracoabdominal surgery at the time of screening.\n* Participant is considered by the investigator, for any reason, to be an unsuitable candidate for the study.\n\nParticipant may have additional cohort-specific requirements.",{"count":97,"type":22},600,[99],"PHASE2","This is a Phase 2 multicenter, randomized, double-blinded, placebo-controlled study that will evaluate the safety and efficacy of host-directed therapeutics in hospitalized adults diagnosed with Acute Respiratory Distress Syndrome (ARDS) utilizing a platform trial design. Participants will be randomized to receive either a placebo or one of the active treatments.\n\nThis record describes the default procedures and analyses for all cohorts. Each specific cohort may have additional eligibility requirements, safety and efficacy procedures, or endpoints, which will be described in the corresponding intervention-specific records on clinicaltrials.gov listed below in the detailed description.",[28,35,102,36],"ARDS (Acute Respiratory Distress Syndrome)",[104,105,35,36,106],"BARDA","JUST BREATHE","Acute Respiratory Failure","2026-07-29",{"date":109,"type":50},"2026-07-31",{"date":111,"type":50},"2025-06-10",{"date":113,"type":22},"2028-09",{"name":115,"class":116},"PPD Development, LP","INDUSTRY",41,{"id":119,"slug":120,"hasResults":12,"nctId":121,"briefTitle":122,"officialTitle":94,"acronym":4,"eligibilityCriteria":123,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":124,"targetDuration":4,"studyType":23,"phases":126,"briefSummary":127,"conditions":128,"keywords":129,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":130,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":134,"locationsCount":117},"100570010","phase-2-just-breathe-breathing-life-into-innovative-therapies-for-ards--cohort-a-vilobelimab-100570010","NCT06701682","JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS- Cohort A: Vilobelimab","Inclusion Criteria:\n\nThe following inclusion criteria are in addition to the exclusion criteria specified in the Master Protocol NCT06703073.\n\n* ARDS Severity of moderate or severe based on PaO2\u002FFiO2 or SpO2\u002FFiO2 assessment at the time of randomization\n\nExclusion Criteria:\n\nThe following exclusion criteria are in addition to the exclusion criteria specified in the Master Protocol NCT06703073.\n\n* Participant with established cirrhosis and a modified Child-Pugh Score of 12 or greater",{"count":125,"type":22},200,[99],"This is a Phase 2 multicenter, randomized, double-blinded, placebo-controlled study that will evaluate the safety and efficacy of host-directed therapeutics in hospitalized adults diagnosed with Acute Respiratory Distress Syndrome (ARDS) utilizing a platform trial design.\n\nCohort A: Participants will be randomized to receive either a placebo or vilobelimab.\n\nThis record describes the default procedures and analyses for Cohort A. Please see NCT06703073 for information on the BP-ARDS-P2-001 Master Protocol.",[28,35,102,36],[104,105,35,36,106],{"date":109,"type":50},{"date":132,"type":50},"2025-06-21",{"date":113,"type":22},{"name":115,"class":116},{"id":136,"slug":137,"hasResults":12,"nctId":138,"briefTitle":139,"officialTitle":94,"acronym":4,"eligibilityCriteria":140,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":141,"targetDuration":4,"studyType":23,"phases":142,"briefSummary":143,"conditions":144,"keywords":145,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":146,"startDateStruct":147,"completionDateStruct":148,"leadSponsor":149,"locationsCount":117},"100570009","phase-2-just-breathe-breathing-life-into-innovative-therapies-for-ards--cohort-b-paridiprubart-100570009","NCT06701669","JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS- Cohort B: Paridiprubart","Inclusion Criteria:\n\nThe following inclusion criteria are in addition to the exclusion criteria specified in the Master Protocol NCT06703073:\n\n* ARDS Severity of moderate or severe based on PaO2\u002FFiO2 or SpO2\u002FFiO2 assessment at the time of randomization.\n\nExclusion Criteria:\n\nThe following exclusion criteria are in addition to the exclusion criteria specified in the Master Protocol NCT06703073.\n\n* Participant has a known allergy or known hypersensitivity to paridiprubart or its excipients, including polysorbate 80\n* Participant with established cirrhosis and a modified Child-Pugh Score of 12 or greater",{"count":125,"type":22},[99],"This is a Phase 2 multicenter, randomized, double-blinded, placebo-controlled study that will evaluate the safety and efficacy of host-directed therapeutics in hospitalized adults diagnosed with Acute Respiratory Distress Syndrome (ARDS) utilizing a platform trial design.\n\nCohort B: Participants will be randomized to receive either a placebo or paridiprubart.\n\nThis record describes the default procedures and analyses for Cohort B. Please see NCT06703073 for information on the BP-ARDS-P2-001 Master Protocol.",[28,35,102,36],[104,105,35,36,106],{"date":109,"type":50},{"date":111,"type":50},{"date":113,"type":22},{"name":115,"class":116},{"id":151,"slug":152,"hasResults":12,"nctId":153,"briefTitle":154,"officialTitle":94,"acronym":4,"eligibilityCriteria":155,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":156,"targetDuration":4,"studyType":23,"phases":157,"briefSummary":158,"conditions":159,"keywords":160,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":161,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":165,"locationsCount":117},"100570008","phase-2-just-breathe-breathing-life-into-innovative-therapies-for-ards--cohort-c-bevacizumab-100570008","NCT06701656","JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS- Cohort C: Bevacizumab","Inclusion Criteria:\n\nThe following inclusion criteria are in addition to the exclusion criteria specified in the Master Protocol NCT06703073.\n\n* ARDS Severity of mild, moderate or severe, based on PaO2\u002FFiO2 or SpO2\u002FFiO2 assessment at the time of randomization.\n\nExclusion Criteria:\n\nThe following exclusion criteria are in addition to the exclusion criteria specified in the Master Protocol NCT06703073.\n\n* Participant has a known allergy or hypersensitivity to the active substance\u002Fexcipients, or Chinese Hamster Ovary cell products or other recombinant human or humanized antibodies\n* Participant with established cirrhosis and a modified Child-Pugh Score of 7 or greater\n* Participant was dialysis-dependent prior to hospitalization. Participant must have a urine dipstick for proteinuria \\\u003C 2+\n* The hospitalized participant has a history or currently experiencing the following:\n\n  1. Participant must not have an international normalized ratio (INR) \\>1.5 and\u002For aPTT \\>1.5 × upper limit of normal (ULN) within 7 days prior to initiation of study treatment for participants not receiving anticoagulation. For participants on full dose oral or parenteral anticoagulants for therapeutic purposes the INR and\u002For activated partial thromboplastin time (aPTT) must be within therapeutic limits (according to institution standards) within 7 days prior to initiation of study treatment and the participant on a stable dose of anticoagulants for ≥ 2 weeks prior to initiation of study treatment.\n  2. Participant with recent serious hemorrhage or history of recent hemoptysis \\> 2 episodes (defined as ≥2.5 mL of bright red blood per episode) within 1 month of screening.\n  3. Participant with inadequately controlled hypertension (defined as systolic blood pressure \\> 150 mmHg and\u002For diastolic blood pressure \\> 100 mmHg). Antihypertensive therapy is permitted to achieve these parameters.\n  4. Participant with a history of hypertensive crisis or hypertensive encephalopathy.\n  5. Participant with a history of Grade ≥ 4 venous thromboembolisms.\n  6. Participant with significant vascular disease (eg, aortic aneurysm requiring surgical repair or recent arterial thrombosis) within 3 months of study drug treatment.\n  7. Participant with history of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess, or active gastrointestinal bleeding within 6 months of study drug treatment.\n  8. Participant with serious, non-healing wound, active ulcer, or untreated bone fracture.\n  9. Participant with history or evidence of inherited bleeding diathesis or significant coagulopathy at risk of bleeding (ie, in the absence of therapeutic anticoagulation).\n  10. Participant with clinically significant cardiovascular disease including cerebrovascular accident or myocardial infarction within previous 6 months, unstable angina, congestive heart failure, or serious cardiac arrhythmia uncontrolled by medication.\n  11. Participant with a platelet count of \\\u003C75×109\u002FL.\n  12. Participant with current or recent (\\\u003C10 days prior to initiation of study treatment) use of aspirin (\\>325 mg\u002Fday) or clopidogrel (\\>75 mg\u002Fday).\n  13. Participant is receiving a direct anticoagulant (DOAC) such as dabigatran (Pradaxa®) and rivaroxaban (Xarelto®) without the availability of a reversal agent at the site.\n  14. Participant is receiving a DOAC such as betrixaban (Bevyxxa®) and edoxaban (Lixiana®) for which there is no approved reversal agent.\n  15. Participant has urine dipstick for proteinuria ≥ 2+",{"count":125,"type":22},[99],"This is a Phase 2 multicenter, randomized, double-blinded, placebo-controlled study that will evaluate the safety and efficacy of host-directed therapeutics in hospitalized adults diagnosed with Acute Respiratory Distress Syndrome (ARDS) utilizing a platform trial design.\n\nCohort C: Participants will be randomized to receive either a placebo or bevacizumab.\n\nThis record describes the default procedures and analyses for Cohort C. Please see NCT06703073 for information on the BP-ARDS-P2-001 Master Protocol.",[28,35,102,36],[104,105,35,36,106],{"date":109,"type":50},{"date":163,"type":50},"2025-10-28",{"date":113,"type":22},{"name":115,"class":116},{"id":167,"slug":168,"hasResults":12,"nctId":169,"briefTitle":170,"officialTitle":171,"acronym":172,"eligibilityCriteria":173,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":174,"targetDuration":4,"studyType":23,"phases":176,"briefSummary":177,"conditions":178,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":4},"100643194","a-study-of-the-determinants-of-neurological-outcomes-in-patients-with-acute-respiratory-distress-syndrome-100643194","NCT07629973","A Study of the Determinants of Neurological Outcomes in Patients With Acute Respiratory Distress Syndrome","Etude Des déterminants de l'évolution NEUrologique Des Patients Ayant présenté un Syndrome de Détresse Respiratoire aiguë","NEURDS","Inclusion Criteria:\n\n* Adult patient\n* Patient admitted to the intensive care unit less than 48 hours ago\n* Patient diagnosed with mild, moderate or severe ARDS according to the Berlin classification based on the PaO₂\u002FFiO₂ ratio, with a minimum PEEP set at 5 cmH₂O (16), of pulmonary aetiology:\n\n  * Mild ARDS: 200 \\\u003C PaO₂\u002FFiO₂ \\\u003C 300 mmHg\n  * Moderate ARDS: 100 \\\u003C PaO₂\u002FFiO₂ \\\u003C 200 mmHg\n  * Severe ARDS: PaO₂\u002FFiO₂ \\\u003C 100 mmHg\n* Patients fitted with an oesophageal pressure measurement catheter (Nutrivent, Sidam, San Giacomo Roncole, Italy)\n* Patients registered with or covered by a social security scheme\n* Free and informed consent from the patient or a trusted relative (where the patient is unable to give consent).\n\nExclusion Criteria:\n\n* Patients with a history of central nervous system disorders resulting in cognitive impairment\n* Patients on ECMO\n* Patients admitted for symptomatic central nervous system disorders\n* Patients admitted for acute respiratory distress syndrome following cardiorespiratory arrest.\n* Patients being treated for a psychiatric condition, chronic heavy drinkers, or those undergoing long-term treatment with benzodiazepines, antidepressants or antipsychotics.\n* Pregnant, breastfeeding or labouring patients\n* Individuals subject to a legal protection order\n* Individuals receiving compulsory psychiatric care\n* Individuals deprived of their liberty by judicial or administrative decision",{"count":175,"type":22},150,[25],"Acute respiratory distress syndrome (ARDS) is characterized by pathological pulmonary edema caused by direct or indirect damage to the alveolar-capillary membrane.\n\nIts management relies on etiological treatment, invasive mechanical ventilation, and the use of sedatives and neuromuscular blockers, depending on the patient's condition.\n\nImprovements in patient care have led to an improved prognosis. However, in-hospital mortality remains high (between 35% and 45%). Notably, morbidity among surviving patients is very high and is largely dominated by neuropsychological sequelae. Attention and executive function disorders, confusion, disorientation, or memory impairment are thus found in 70 to 100% of patients following ARDS. These disorders are still present in 46 to 80% of surviving patients one year after ARDS and in 20% of them five years later.\n\nAlthough essential to treatment, mechanical ventilation carries a risk of significant complications. Beyond the risk of infection and complications related to sedation and neuromuscular blockade, the use of mechanical ventilation is associated with a risk of ventilator-induced lung injury (VILI).\n\nThe use of so-called protective ventilation reduces the risk of VILI and improves patient outcomes. However, analysis of relevant physiological parameters shows that the risk of VILI may still exist even when ventilator settings comply with recommendations and the concept of protective ventilation. Driving pressure (which represents Strain) is a good marker of VILI; it represents the distension of the lung with each breath relative to the initial lung volume. Values above 14 cmH₂O are associated with high mortality in patients with ARDS. Inspiratory transpulmonary pressure represents Stress-that is, the pressure that distends the alveoli at the end of inspiration-and is also associated with the risk of VILI. Finally, mechanical power represents the amount of energy delivered to the lung by the ventilator and has been validated as a marker of VILI. The advantage of mechanical power over the other indices described is that it incorporates all components that can lead to VILI.\n\nAmong the various sources of neurological damage during ARDS, inflammatory processes appear to play a major role. Numerous inflammatory mediators (TNF-α, IL-6, IL-8, IL-1β) are secreted during ARDS, and animal studies have demonstrated a link between inflammation and hippocampal damage. Furthermore, cerebral ischemic lesions, exacerbated by systemic inflammation and endothelial activation leading to coagulation activation with thrombus formation, may also contribute to the development of cognitive impairments.\n\nIn addition to the inflammatory processes associated with ARDS, mechanical ventilation itself may have a significant impact on neuroinflammatory damage. Recently, the term \"ventilator-associated brain injury\" (VABI) has been proposed to describe these secondary neurological lesions induced by mechanical ventilation. Studies in mouse and pig models have demonstrated a relationship between the dose and duration of VILI, apoptosis, neuroinflammation, and neuronal damage. An animal study in mice also showed an association between the duration of mechanical ventilation and the onset of cognitive impairments.\n\nDuring brain injury, proteins and neurotransmitters are released and serve as biomarkers of brain damage. Elevated plasma levels of S100B protein indicate astrocyte damage caused by traumatic, anoxic-ischemic, or inflammatory mechanisms. It correlates with neurological prognosis following cardiac arrest, in ischemic or hemorrhagic strokes, in neurodegenerative diseases, and in patients with traumatic brain injury.\n\nClinical studies have shown a negative correlation between elevated S100B protein levels, the MoCA (Montreal Cognitive Assessment) score, and the MMSE (Mini-mental state evaluation ) in patients with OSA (Obstructive Sleep Apnea) or COPD (chronic obstructive pulmonary disease), respectively, indicating an association between this protein and cognitive impairment.\n\nThe investigators therefore hypothesize that mechanical ventilation associated with high mechanical power is linked to a significant risk of brain injury, reflected by elevated serum S100B protein levels and the presence of neurocognitive disorders long after ARDS.",[28,179,180,32,181],"s100b","Mechanical Power","Transpulmonary Pressure","2026-07-24",{"date":184,"type":50},"2026-07-27",{"date":186,"type":22},"2026-10-17",{"date":188,"type":22},"2029-10-23",{"name":190,"class":191},"University Hospital, Angers","OTHER_GOV",{"id":193,"slug":194,"hasResults":12,"nctId":195,"briefTitle":196,"officialTitle":197,"acronym":4,"eligibilityCriteria":198,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":199,"targetDuration":201,"studyType":202,"phases":4,"briefSummary":203,"conditions":204,"keywords":205,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":209,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":214,"locationsCount":216},"100648938","immune-mechanisms-and-ecmo-strategies-for-moderate-to-severe-ards-100648938","NCT07726940","Immune Mechanisms and ECMO Strategies for Moderate-to-Severe ARDS","Mechanistic Investigation of Inflammatory and Immune Dysregulation in Moderate-to-Severe ARDS and Rescue Strategies With Extracorporeal Membrane Oxygenation","Inclusion Criteria:\n\n* 1.Age ≥ 18 years 2.Meet the global new definition of moderate-to-severe Acute Respiratory Distress Syndrome (ARDS).\n\nExclusion Criteria:\n\n\\- 1.Patients with a prior tracheostomy. 2.Patients who have received a lung transplant or initiated VV-ECMO support as a bridge to lung transplantation.\n\n3.Patients with comorbid cardiogenic shock requiring VA-ECMO or VAV-ECMO support.",{"count":200,"type":22},1776,"90 Days","OBSERVATIONAL","Acute respiratory distress syndrome (ARDS) poses a major threat to human health. Despite extracorporeal membrane oxygenation (ECMO) support, mortality among patients with ARDS remains high due to severe complications and suboptimal mechanical ventilation strategies. Elucidating the mechanisms underlying ECMO-related complications and lung injury repair, and establishing a precision intervention pathway covering the entire course of ECMO management, are urgent unmet needs for improving outcomes in ARDS patients and addressing major public health challenges.\n\nThis project focuses on five key scientific questions:\n\n1. How can moderate-to-severe ARDS be classified into distinct clinical-immune phenotypes, and what are the optimal therapeutic targets for each phenotype?\n2. What are the molecular mechanisms underlying severe complications in ARDS patients receiving ECMO support?\n3. Which key immune biomarkers are associated with clinical benefit from awake ECMO?\n4. How should mechanical ventilation strategies be optimized in moderate-to-severe ARDS patients supported with ECMO?\n5. How can a comprehensive, full-cycle ECMO management pathway be established for patients with moderate-to-severe ARDS?\n\nThe project consists of five interrelated subprojects:\n\nSubproject 1. Construction of Clinical-Immune Phenotypes and Identification of Therapeutic Targets in Moderate-to-Severe ARDS Clinical phenotypes and longitudinal multidimensional biospecimens collected throughout the disease course in moderate-to-severe ARDS patients, including those receiving ECMO support, will be analyzed to characterize the heterogeneity and spatiotemporal interactions of inflammatory and immune cell subsets and to identify effective therapeutic targets.\n\nSubproject 2. Mechanisms and Interventions for Immune Dysregulation Underlying Severe ECMO-Related Complications This subproject aims to elucidate the inflammatory and immune mechanisms responsible for major complications occurring in ARDS patients receiving ECMO support. Major complications of interest include acute kidney injury, bleeding and thrombosis, and infection.\n\nSubproject 3. Development and Validation of a Clinical-Immune Phenotype-Guided Decision System for Awake ECMO By integrating multidimensional data, a comprehensive ARDS phenotyping framework will be established to identify patients most likely to benefit from awake ECMO. A clinical decision-making system will be developed and subsequently validated through multicenter studies to assess its effectiveness.\n\nSubproject 4. Molecular Mechanisms of Lung Repair and Optimization of Mechanical Ventilation During ECMO Support This subproject will investigate the lung-protective effects of different invasive mechanical ventilation strategies and ventilation parameters during ECMO support. Multi-omics analyses of ARDS biospecimens will be performed to elucidate the mechanisms through which lung rest promotes tissue repair and recovery.\n\nSubproject 5. Establishment and Evaluation of a Full-Cycle ECMO Management Strategy for Moderate-to-Severe ARDS Based on evidence-based medicine and multidisciplinary collaboration, a comprehensive ECMO management pathway covering the entire disease course will be developed for patients with moderate-to-severe ARDS. Real-world studies will be conducted to evaluate its clinical effectiveness and facilitate continuous optimization.\n\nOverall, this project aims to provide mechanistic insights into immune dysregulation, ECMO-related complications, and lung repair, while establishing a precision, full-cycle ECMO management framework to improve outcomes in patients with moderate-to-severe ARDS.\\*\\*",[28],[36,35,29,37,206,207],"Lung-protective Ventilation","Immune Phenotype","2026-07-21",{"date":184,"type":50},{"date":211,"type":50},"2026-06-16",{"date":213,"type":22},"2030-02",{"name":215,"class":57},"Southeast University, China",39,{"id":218,"slug":219,"hasResults":12,"nctId":220,"briefTitle":221,"officialTitle":222,"acronym":4,"eligibilityCriteria":223,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":224,"targetDuration":4,"studyType":23,"phases":226,"briefSummary":228,"conditions":229,"keywords":230,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":233,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":58},"100647681","phase-4-identifying-an-optimal-corticosteroid-dosage-regimen-for-acute-respiratory-distress-syndrome-100647681","NCT07711964","Identifying an Optimal Corticosteroid Dosage Regimen for Acute Respiratory Distress Syndrome","Corticosteroids for Acute Respiratory Distress Syndrome: A Proof-of-Concept Trial Exploring Biological Heterogeneity and Treatment Response","Inclusion Criteria:\n\n* ARDS (as defined by the Berlin definition) with an FiO₂ of 0.5 or higher\n* On invasive mechanical ventilation\n* Duration of intubation less than three days\n\nExclusion Criteria:\n\n* Age less than 18 years\n* Required to receive steroids or considered ineligible for steroids by the primary care team\n* Receiving systemic steroid therapy\n* Uncontrolled gastrointestinal bleeding\n* Uncontrolled infeciotn",{"count":225,"type":22},300,[227],"PHASE4","The early phase of Acute Respiratory Distress Syndrome (ARDS) is characterized by intense alveolar inflammation. Corticosteroids have been used to treat ARDS for decades. Although their efficacy has been a subject of ongoing controversy, recent clinical practice guidelines for ARDS issued a weak recommendation in favor of corticosteroid use in early ARDS. However, the optimal dose and duration of corticosteroid therapy remain unclear. Low-dose, short-course regimens have been evaluated in clinical trials for severe pneumonia and COVID-19. However, no head-to-head comparisons have been conducted to evaluate the efficacy of prolonged versus short courses of corticosteroid therapy in ARDS.\n\nTo address this gap, the investigators designed a 3×2 factorial trial to assess corticosteroid therapy for ARDS, aiming to evaluate the effects of different doses (no steroid, medium-low dose, and medium dose) and durations (prolonged vs. short) on clinical outcomes. In addition, the investigators will measure changes in inflammatory biomarkers for post hoc analysis to explore whether these biomarkers could guide the selection of steroid regimens.",[28],[36,35,231],"Corticosteroid","2026-07-16",{"date":234,"type":50},"2026-07-17",{"date":236,"type":50},"2025-06-15",{"date":238,"type":22},"2030-06-30",{"name":240,"class":57},"National Taiwan University Hospital",{"id":242,"slug":243,"hasResults":12,"nctId":244,"briefTitle":245,"officialTitle":246,"acronym":247,"eligibilityCriteria":248,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":249,"targetDuration":4,"studyType":23,"phases":251,"briefSummary":252,"conditions":253,"keywords":254,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":263,"lastUpdatePostDateStruct":264,"startDateStruct":266,"completionDateStruct":268,"leadSponsor":270,"locationsCount":4},"100647892","comparison-of-lung-recruitability-assessment-by-hysteresis-ratio-and-recruitment-to-inflation-ratio-and-peep-titration-in-ards-100647892","NCT07713420","COMPARISON OF LUNG RECRUITABILITY ASSESSMENT BY HYSTERESIS RATIO AND RECRUITMENT-TO-INFLATION RATIO, AND PEEP TITRATION IN ARDS.","COMPARISON OF LUNG RECRUITABILITY ASSESSMENT BY HYSTERESIS RATIO AND RECRUITMENT-TO-INFLATION RATIO AND THE USE OF DIFFERENT PEEP TITRATION METHODS IN PATIENTS WITH ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS)","PV-TOOL","Inclusion Criteria:\n\n* Intubated patients with acute respiratory distress syndrome (ARDS): PaO2\u002FFiO2 ratio \\\u003C200, with bilateral infiltrates of non-cardiogenic origin, with a PEEP of at least 5 cmH2O.\n* The patient is receiving mechanical ventilation and continuous sedation.\n* The patient has an esophageal balloon.\n* Written informed consent signed and dated by the patient or one relative in case the patient is unable to consent, after a full explanation of the study by the investigator and prior to study participation\n\nExclusion Criteria:\n\n* Patients with\\\u003C 18 years old\n* Pregnant woman\n* Lung recruitment maneuvers are deemed unsafe by the medical team\n* Unable to fit EIT belt due to patient size\n* Contraindications to EIT monitoring (e.g. burns, pacemaker, thoracic wounds limiting electrode placement)\n* Hemodynamic instability (Systolic BP \\\u003C 75 mmHg or MAP \\\u003C 60 mmHg despite vasopressors and\u002For heart rate \\\u003C 55 bpm)\n* Hypernatremia (Na+ \\>145mEq\u002FL)\n* The formalized ethical decision to withhold or withdraw life support\n* Patient under guardianship\n* Patients deprived of liberties\n* Impossibility to give informed consent by both patient and family (i.e. language barrier)\n* Patient was already enrolled in the present study in a previous episode of acute respiratory failure.",{"count":250,"type":22},30,[25],"This multicenter, single-blind physiological study aims to compare two bedside methods for assessing lung recruitability in mechanically ventilated patients with acute respiratory distress syndrome (ARDS): the recruitment-to-inflation (R\u002FI) ratio and the pressure-volume (PV) loop hysteresis ratio. Lung recruitability will be defined according to the reduction in lung collapse measured by electrical impedance tomography (EIT) during a standardized lung recruitment maneuver.\n\nFollowing baseline measurements, participants will undergo sequential physiological assessments, including lung recruitability evaluation using both the R\u002FI ratio and a low-flow PV loop, a standardized lung recruitment maneuver with a decremental PEEP trial, and a second PV loop performed at a lower maximum inflation pressure. The order of the R\u002FI ratio assessment and the PV loop maneuver will be randomized.\n\nIn a final crossover phase, four different PEEP titration strategies will be evaluated in randomized order. Each strategy will be applied for 15 minutes and separated by a washout period at the patient's baseline clinical PEEP. Respiratory mechanics, gas exchange, ventilation\u002Fperfusion distribution, and hemodynamic variables will be assessed throughout the protocol.\n\nThe primary objective is to determine the agreement between the hysteresis ratio and the R\u002FI ratio for identifying lung recruitability. Secondary objectives include evaluating whether a PV loop performed with a lower maximum pressure provides similar information on recruitability and comparing the physiological effects of different PEEP titration strategies. Approximately 30 patients with moderate-to-severe ARDS receiving invasive mechanical ventilation will be enrolled.",[28],[255,256,257,258,259,260,261,262,36],"Mechanical ventilation","Lung recruitability","PEEP titration","Hysteresis Ratio","Recruitment-to-Inflation Ratio","Pressure-Volume Loop","Electrical Impedance Tomography (EIT)","Esophageal Pressure","2026-07-14",{"date":265,"type":50},"2026-07-20",{"date":267,"type":22},"2026-07",{"date":269,"type":22},"2029-01",{"name":271,"class":57},"Oriol Roca",{"id":273,"slug":274,"hasResults":12,"nctId":275,"briefTitle":276,"officialTitle":277,"acronym":4,"eligibilityCriteria":278,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":279,"targetDuration":4,"studyType":23,"phases":281,"briefSummary":283,"conditions":284,"keywords":285,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":263,"lastUpdatePostDateStruct":291,"startDateStruct":293,"completionDateStruct":295,"leadSponsor":297,"locationsCount":58},"100617317","phase-3-clinical-trial-with-aprotinin-in-the-acute-respiratory-distress-syndrome-treatment-100617317","NCT07317050","Clinical Trial With Aprotinin in the Acute Respiratory Distress Syndrome Treatment","Aprotinin Treatment of Acute Respiratory Distress Syndrome: a Multicenter, Double-blind, Placebo-controlled, Phase III Trial","Inclusion Criteria:\n\nEach potential participant must satisfy all of the following criteria to be enrolled in the study:\n\n1. Diagnosed with moderate or severe Acute Respiratory Distress Syndrome (ARDS) according to the Berlin definition (ARDS Definition Task Force 2012):\n\n   * Acute onset of respiratory failure within 1 week of a known clinical insult or new\u002Fworsening respiratory symptoms.\n   * Respiratory failure not fully explained by cardiac failure or fluid overload; objective evaluation of cardiac failure or fluid overload is required if ARDS risk factors are absent.\n   * Radiographic abnormalities on chest X-ray or CT scan: bilateral opacities not fully explained by effusions, nodules, masses, or lobar\u002Fsegmental collapse.\n   * Hypoxemia:\n\n     * Moderate ARDS: PaO₂\u002FFiO₂ \\>100 mmHg and ≤200 mmHg with Positive End-Expiratory Pressure (PEEP) ≥5 cmH₂O.\n     * Severe ARDS: PaO₂\u002FFiO₂ ≤100 mmHg with PEEP ≥5 cmH₂O.\n2. Radiographic and hypoxemia criteria must occur within the same 24-hour period. ARDS onset is defined as the time when the last of these two criteria is met.\n3. First dose of study drug planned within 48 hours of moderate or severe ARDS diagnosis.\n4. Intubated and receiving mechanical ventilation.\n5. Age ≥18 years.\n6. Women of childbearing potential must have a negative serum pregnancy test during screening and a negative urine pregnancy test at study start. Female subjects of childbearing potential and male subjects with partners of childbearing potential must agree to use an effective contraceptive method from consent until 30 days after study drug administration.\n\nExclusion Criteria:\n\nAny potential participant who meets any of the following criteria will be excluded from participating in the study:\n\n1. Pregnant or lactating women, or positive\u002Findeterminate pregnancy test (serum or urine).\n2. Simultaneous participation in another pharmacotherapy protocol.\n3. Life expectancy \\\u003C24 hours.\n4. Clinical condition in which, in the investigator's opinion, ventilator withdrawal is extremely unlikely (e.g., motor neuron disease, Duchenne muscular dystrophy, rapidly progressive interstitial lung disease).\n5. Severe chronic obstructive pulmonary disease requiring long-term home oxygen or mechanical ventilation (noninvasive or tracheostomy), except Continuous Positive Airway Pressure (CPAP) or Bilevel Positive Airway Pressure (BiPAP) used solely for sleep-related respiratory disorders.\n6. Congestive heart failure defined as New York Heart Association (NYHA) class IV.\n7. Acute left ventricular failure.\n8. Severe hepatic impairment (Child-Pugh class C).\n9. Prior interferon therapy.\n10. Known hypersensitivity to natural or recombinant IFN beta or any excipients.\n11. Receiving renal dialysisfor chronic renal failure.\n12. Receiving extracorporeal membrane oxygenation (ECMO), high-frequency oscillatory ventilation, or any form of extracorporeal pulmonary support.\n13. Mechanical ventilation, (invasive or noninvasive, excluding CPAP alone), for more than 48 hours before ARDS diagnosis. Noninvasive ventilation must be applied continuously for at least 12 hours\u002Fday during those 48 hours.\n14. Burns covering ≥15% total body surface.\n15. Women with positive pregnancy test at screening (serum) or study start (urine); lactating subjects; subjects planning pregnancy within 1 month after the study (including male partners).",{"count":280,"type":22},156,[282],"PHASE3","This is a multicentre, double-blind, placebo-controlled Phase III randomized clinical trial designed to evaluate the efficacy and safety of inhaled aprotinin in adult patients with moderate or severe acute respiratory distress syndrome (ARDS). A total of 156 critically ill patients admitted to intensive care units will be randomized to receive either inhaled aprotinin or placebo in addition to standard supportive care. The primary objective is to determine whether aprotinin improves clinical outcomes based on a composite endpoint of ventilator-free days at 28 days.",[28],[28,286,287,288,289,290],"Inhaled Aprotinin","Phase III Clinical Trial","Ventilator-free days","Pulmonary Function","Inflammatory Biomarkers",{"date":292,"type":50},"2026-07-15",{"date":294,"type":50},"2026-06-18",{"date":296,"type":22},"2030-03-01",{"name":298,"class":57},"Fundacion del Hospital Nacional de Paraplejicos para la Investigacion y la Integracion",{"id":300,"slug":301,"hasResults":12,"nctId":302,"briefTitle":303,"officialTitle":303,"acronym":304,"eligibilityCriteria":305,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":306,"targetDuration":4,"studyType":23,"phases":308,"briefSummary":309,"conditions":310,"keywords":311,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":315,"lastUpdatePostDateStruct":316,"startDateStruct":318,"completionDateStruct":320,"leadSponsor":322,"locationsCount":58},"100639468","phase-3-dexamethasone-treatment-for-sepsis-associated-acute-respiratory-distress-syndrome-a-multicenter-randomised-double-blinded-controlled-trial-100639468","NCT07576660","Dexamethasone Treatment for Sepsis-associated Acute Respiratory Distress Syndrome: a Multicenter, Randomised, Double-blinded, Controlled Trial","DEFEND","Inclusion Criteria:\n\n1. Age 18 years or older\n2. Suspected or confirmed infection\n3. Receipt of invasive mechanical ventilation with a positive end-expiratory pressure (PEEP) of at least 5 cm H₂O, noninvasive positive-pressure ventilation with a PEEP of at least 5 cm H₂O, or high-flow nasal oxygen therapy with a flow rate of at least 30 L\u002Fmin\n4. Acute-onset ARDS, defined as ARDS diagnosed for at least 6 hours but no more than 72 hours, according to the following criteria:\n\n(1) New or worsening respiratory symptoms or respiratory failure (2) Pulmonary infiltrates on chest radiography or computed tomography, or B-lines or consolidation on lung ultrasonography, not fully explained by pleural effusion, lobar or whole-lung collapse or atelectasis, or pulmonary nodules. Patients with unilateral pulmonary infiltrates, B-lines, or consolidation are eligible (3) Respiratory failure not fully explained by cardiac failure or fluid overload (4) Hypoxemia defined as PaO₂\u002FFiO₂ of 300 mm Hg or less, or SpO₂\u002FFiO₂ of 315 or less, with SpO₂ no greater than 97%.\n\nExclusion Criteria:\n\n1. Pregnancy\n2. Planned withdrawal of life-sustaining treatment within the next 24 hours\n3. Current hospitalization for more than 7 days before screening;\n4. Clinical improvement within the 48 hours before randomization, based on the investigator's overall assessment\n5. Highly suspected or confirmed COVID-19 infection\n6. Severe chronic obstructive pulmonary disease, defined as a PaCO₂ ≥ 60 mmHg in a stable condition, or the need for long-term oxygen therapy, excluding CPAP\u002FBiPAP prescribed exclusively for sleep-disordered breathing.\n7. Congestive heart failure (NYHA III-IV)\n8. A definite clinical indication for high-dose corticosteroids at screening, defined as a maximum daily dose exceeding hydrocortisone 200 mg or an equivalent glucocorticoid dose\n9. Contraindications to short-term dexamethasone, including untreated systemic fungal infection, active tuberculosis, active viral hepatitis, or major upper gastrointestinal bleeding\n10. Known hypersensitivity to dexamethasone\n11. Participation in another interventional clinical trial within the previous 30 days",{"count":307,"type":22},1704,[282],"Acute respiratory distress syndrome (ARDS) is a major cause of acute hypoxemic respiratory failure in critically ill patients and is associated with substantial mortality. Current management is largely supportive, and no pharmacologic therapy has been shown consistently to reduce mortality in a broad population of patients with ARDS. Inflammation plays a central role in the pathogenesis of ARDS. Excessive inflammatory activation contributes to alveolar-capillary injury, impaired gas exchange, and progression of organ dysfunction. Glucocorticoids may mitigate these processes and have been associated in some studies with improved clinical outcomes, including shorter duration of mechanical ventilation. However, the effect of glucocorticoids on survival remains uncertain.\n\nARDS is a heterogeneous syndrome with diverse etiologies, and treatment response may vary according to the underlying cause. A post hoc analysis of the Dex-ARDS trial suggested that the treatment effect of glucocorticoids may be greater in ARDS caused by pneumonia or extrapulmonary sepsis. In a cross-sectional survey of 135 patients with ARDS from 20 ICUs in China, pneumonia- and extrapulmonary sepsis-associated ARDS accounted for 77.6% of cases, indicating that these are the predominant etiologic subtypes encountered in clinical practice in China. More importantly, compared with ARDS attributable to other causes, pneumonia- and extrapulmonary sepsis-associated ARDS has been associated with higher mortality, suggesting a greater disease burden, worse prognosis, and a more urgent need for improved treatment strategies. On this basis, the present trial will enroll patients with ARDS caused by sepsis, including pneumonia and extrapulmonary sepsis.\n\nThe primary hypothesis of this study is that, among patients with sepsis-associated ARDS, dexamethasone plus usual care, as compared with placebo plus usual care, will reduce 90-day all-cause mortality. We therefore designed a multicenter, randomized, double-blind, controlled trial to evaluate the clinical efficacy of dexamethasone in patients with sepsis-associated ARDS. The primary objective is to compare dexamethasone plus usual care with placebo plus usual care with respect to 90-day all-cause mortality.",[28],[312,313,314],"Acute respiratory distress syndrome","Sepsis","Dexamethasone","2026-06-25",{"date":317,"type":50},"2026-06-30",{"date":319,"type":22},"2026-07-01",{"date":321,"type":22},"2030-09-30",{"name":215,"class":57},{"id":324,"slug":325,"hasResults":12,"nctId":326,"briefTitle":327,"officialTitle":327,"acronym":328,"eligibilityCriteria":329,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":330,"targetDuration":4,"studyType":202,"phases":4,"briefSummary":332,"conditions":333,"keywords":334,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":343,"lastUpdatePostDateStruct":344,"startDateStruct":346,"completionDateStruct":347,"leadSponsor":349,"locationsCount":351},"100644188","assessment-of-the-reproducibility-of-the-recruitment-to-inflation-ratio-ri-ratio-measurement-in-patients-with-acute-respiratory-distress-syndrome-100644188","NCT07666503","Assessment of the Reproducibility of the Recruitment-to-inflation Ratio (R\u002FI Ratio) Measurement in Patients With Acute Respiratory Distress Syndrome","RIRR","Inclusion Criteria:\n\n* Adult patient (age ≥ 18 years)\n* Patient hospitalized in the Intensive Care Unit (ICU) for acute respiratory distress syndrome (according to the Berlin definition), requiring invasive mechanical ventilation with deep sedation and controlled mechanical ventilation mode\n* Patient or next of kin informed about the study and not objecting to participation\n\nExclusion Criteria:\n\n* Undrained pneumothorax or any contraindication to a transient increase in airway pressure\n* Known or suspected intracranial hypertension\n* Patient under legal protection (e.g., guardianship)\n* Not affiliated with a social security system\n* Presence of spontaneous respiratory effort\n* Presence of a leak in the ventilatory circuit\n* Hemodynamic instability (e.g., uncontrolled shock, increasing vasopressor requirement)\n* Uncontrolled severe hypoxemia\n* Undrained pneumothorax or any contraindication to a transient increase in airway pressure\n* Known or suspected intracranial hypertension",{"count":331,"type":22},80,"Acute respiratory distress syndrome (ARDS) is a severe lung condition that often requires invasive mechanical ventilation in the intensive care unit. In these patients, setting the ventilator appropriately is essential to improve oxygenation while limiting ventilator-induced lung injury. One important ventilator setting is positive end-expiratory pressure (PEEP), which helps keep the lungs open. However, the optimal PEEP level may vary from one patient to another.\n\nThe recruitment-to-inflation ratio (R\u002FI ratio) is a bedside measurement used to estimate the potential for lung recruitment during a decrease in PEEP. It compares the compliance of the lung volume recruited by PEEP with the compliance of the already aerated lung. A higher R\u002FI ratio suggests that increasing PEEP is more likely to reopen collapsed lung units, whereas a lower R\u002FI ratio suggests limited recruitability and a higher likelihood that additional pressure would mainly distend lung areas that are already open. In clinical practice, the R\u002FI ratio is increasingly used to guide PEEP adjustment, with the aim of improving recruitment and oxygenation while avoiding unnecessary increases in airway pressure. However, although the R\u002FI ratio is used in routine care, there are currently no data demonstrating that this measurement is reproducible when repeated in the same patient under similar conditions.\n\nThe hypothesis of this study is that the R\u002FI ratio is reproducible when measured twice in the same patient under stable conditions, including no significant changes in ventilator settings, hemodynamic status, or ongoing treatments.\n\nThis prospective, multicenter, non-interventional study will include adult ICU patients with ARDS who are receiving invasive mechanical ventilation, deep sedation, and assist-control ventilation. For each patient, airway opening pressure will be assessed, and the R\u002FI ratio will be measured twice on the same day by a trained clinician, between 20 and 120 minutes apart, without changes in ventilator settings or treatments likely to influence the measurement.\n\nThe main objective is to evaluate the within-patient reproducibility of the R\u002FI ratio. Secondary objectives include describing changes in airway opening pressure and R\u002FI ratio over time, assessing the reproducibility of expired tidal volume during the maneuvers, and evaluating the clinical tolerance of these ventilatory measurements.\n\nThe study will include 80 patients across 4 French intensive care units. No additional intervention outside routine care will be performed. Clinical, ventilatory, and biological data already collected as part of usual care will be recorded.",[28],[335,336,337,338,339,340,341,342],"Mechanical Ventilation","Positive End-Expiratory Pressure","Lung Recruitment","Lung Recruitability","Respiratory Mechanics","Airway Opening Pressure","Reproducibility of Results","Intraclass Correlation Coefficient","2026-06-22",{"date":345,"type":50},"2026-06-24",{"date":317,"type":22},{"date":348,"type":22},"2027-06-30",{"name":350,"class":57},"Assistance Publique - Hôpitaux de Paris",4,{"id":353,"slug":354,"hasResults":12,"nctId":355,"briefTitle":356,"officialTitle":357,"acronym":4,"eligibilityCriteria":358,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":359,"enrollmentInfo":360,"targetDuration":4,"studyType":23,"phases":362,"briefSummary":363,"conditions":364,"keywords":365,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":368,"lastUpdatePostDateStruct":369,"startDateStruct":371,"completionDateStruct":373,"leadSponsor":375,"locationsCount":4},"100633554","phase-3-study-of-xuanbai-shengmai-decoction-in-the-treatment-of-acute-respiratory-distress-syndrome-100633554","NCT07528196","Study of Xuanbai Shengmai Decoction in the Treatment of Acute Respiratory Distress Syndrome","Clinical Collaboration Project of Integrated Traditional Chinese and Western Medicine for Major and Intractable Diseases - A Multicenter, Randomized Controlled Trial of Xuanbai Shengmai Decoction in the Treatment of Acute Respiratory Distress Syndrome","Inclusion Criteria:\n\n1. Met the diagnostic criteria for ARDS according to the 2023 updated global definition.\n2. Within 48 hours of meeting the diagnostic criteria.\n3. Aged ≥ 18 years and ≤ 85 years.\n\nExclusion Criteria:\n\n1. Did not meet the diagnostic criteria.\n2. Pregnant or lactating women.\n3. Patients with gastrointestinal dysfunction (including gastrointestinal bleeding, severe intra-abdominal hypertension, severe intestinal obstruction, etc.), resulting in the inability to administer medication via nasogastric\u002Fnasoenteric tube or orally within 48 hours after enrollment.\n4. SOFA score \\> 13.\n5. Hypersensitivity to the study drugs.\n6. Withdrawal of treatment.","85 Years",{"count":361,"type":22},308,[282],"Acute respiratory distress syndrome (ARDS) is a common clinical syndrome in the ICU characterized by extremely high mortality and complex pathogenesis.At present, research on individualized treatment, phenotypic differences, and therapeutic efficacy in ARDS has become a hotspot.As characterized by syndrome differentiation, traditional Chinese medicine (TCM) treatment emphasizes interindividual heterogeneity and personalized management, which is expected to serve as a breakthrough in multi-target immune regulation for ARDS. The primary objective of the study is to investigate the effect of Xuanbai Shengmai Decoction on the prognosis of patients with ARDS in a prospective randomized controlled trial. The secondary objective is to evaluate the safety of Xuanbai Shengmai Decoction in the treatment of patients with ARDS.",[28],[28,366,367],"Traditional Chinese Medicine","Xuanbai Shengmai Decoction","2026-06-03",{"date":370,"type":50},"2026-06-05",{"date":372,"type":22},"2026-08-20",{"date":374,"type":22},"2027-12",{"name":215,"class":57},{"id":377,"slug":378,"hasResults":12,"nctId":379,"briefTitle":380,"officialTitle":380,"acronym":381,"eligibilityCriteria":382,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":383,"targetDuration":4,"studyType":202,"phases":4,"briefSummary":384,"conditions":385,"keywords":386,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":392,"lastUpdatePostDateStruct":393,"startDateStruct":395,"completionDateStruct":397,"leadSponsor":399,"locationsCount":58},"100599897","pulmonary-overdistension-assessment-with-electrical-impedance-tomography-in-patients-with-acute-respiratory-distress-syndrom-in-prone-position-100599897","NCT07090460","Pulmonary Overdistension Assessment With Electrical Impedance Tomography in Patients With Acute Respiratory Distress Syndrom in Prone Position.","Tomo-BPCO","Inclusion Criteria:\n\n* Patients hospitalized in the ICU and who suffered moderate or severe COP (Gold 3 and 4)), with respiratory acidosis under NIV or intubated, and equipped with EIT over the age of 18.\n\nExclusion Criteria:\n\n* Broncho-pleural leaks\n* Pregnant or breastfeeding woman.\n* Guardianship or curatorship\n* Deprived of liberty\n* No health insurance\n* Impossibility to correctly position the EIT belt (e.g., dressings, chest drainage, etc.)\n* Contra indications to EIT (e.g., implantable cardiac defibrillator, pacemaker, instable spinal lesions)",{"count":250,"type":22},"Mechanical ventilation in COPD requires a good interaction Patient-Ventilator without asynchronies in order to reduce mortality. Dynamic hyperinflation with PEEPi is responsible for major asynchronies in COPD. It is supposed to be symmetrical between the 2 lungs with the same PEEPi. EIT can measure the distribution of tidal ventilation and interlung lung insufflation delay on the impedance time curve of each lung. Moreover, it is possible in intubated COPD patients to assess one lung PEEPi during low flow insufflation with pressure-EIT monitoring.\n\nThis study aims to measure interlungs insufflation delay under mechanical ventilation in COPD patients",[28],[387,335,388,389,390,391],"Chronic Obstructive Pulmonary Disease","NIV","Asynchronies","Electrical Impedance Tomography","Pressure Impedance curve","2026-05-28",{"date":394,"type":50},"2026-06-01",{"date":396,"type":50},"2025-11-22",{"date":398,"type":22},"2026-09",{"name":400,"class":57},"Centre Hospitalier de la côte Basque",{"id":402,"slug":403,"hasResults":12,"nctId":404,"briefTitle":405,"officialTitle":405,"acronym":406,"eligibilityCriteria":407,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":408,"targetDuration":4,"studyType":202,"phases":4,"briefSummary":410,"conditions":411,"keywords":412,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":416,"lastUpdatePostDateStruct":417,"startDateStruct":419,"completionDateStruct":421,"leadSponsor":423,"locationsCount":58},"100623318","study-of-the-immunological-pathophysiological-mechanisms-associated-with-acute-respiratory-distress-syndrome-100623318","NCT07395076","Study of the Immunological Pathophysiological Mechanisms Associated With Acute Respiratory Distress Syndrome","IMMUNORESP2","Inclusion Criteria:\n\n* ARDS risk factors: bacterial or viral pneumonia, extrapulmonary infection, major trauma, transfusion, inhalation injury, or shock.\n* Pulmonary edema not explained by a cardiogenic cause or volume overload.\n* Onset of respiratory symptoms within \\\u003C7 days.\n* Bilateral pulmonary involvement on chest X-ray, CT scan, or ultrasound.\n* PaO₂\u002FFiO₂ ≤ 300 assessed with PEEP ≥ 5 cmH₂O.\n\nExclusion Criteria:\n\n* ARDS with intubation for more than 48 hours.\n* Contraindications to bronchoscopy: effective anticoagulation, dual antiplatelet therapy, thrombocytopenia \\\u003C50 G\u002FL.\n* Pre-existing immunodeficiency: active solid tumor or remission \\\u003C5 years, active hematologic malignancy or remission \\\u003C5 years, systemic disease (even without specific treatment), solid organ or bone marrow transplant, HIV infection with CD4 \\\u003C200\u002Fmm³.\n* Cardiac arrest with a poor prognosis (NSE \\>60, malignant EEG, diffuse ischemia on imaging, loss of trunk reflexes).\n* Patients \\\u003C18 year-old\n* Patients under legal guardianship, curatorship, or deprived of liberty.\n* Ongoing pregnancy.\n* Patients without social security coverage.",{"count":409,"type":22},50,"About 10% of patients admitted to the ICU suffer from ARDS, with a mortality rate of around 35-45%. The lack of therapeutic innovation in ARDS can be partly explained by the heterogeneity of patients included under this definition.\n\nA better understanding of the pathophysiological mechanisms underlying the different patient phenotypes is essential to develop new therapeutic strategies.\n\nObjectives:\n\nTo characterize the inflammatory profile of patients with ARDS using circulating biomarkers and single-cell RNA sequencing of pulmonary immune cells.\n\nThe investigators hypothesize that there is a correlation between the profile of serum biomarkers (inflammatory sub-phenotypes), the transcriptome of pulmonary immune cells.\n\nBriefly the experimental scheme is as follow:\n\n* Population: patients with ARDS under invasive mechanical ventilation in the ICU.\n* Intervention:\n\n  1. Determination of the inflammatory subphenotype on circulatory inflammatory biomarkers.\n  2. Characterization of inflammation by single cell RNA sequencing on lung immune cells collected on broncho-alveolar fluid.",[28],[413,414,415],"acute respiratory distress syndrome","subphenotypes","ADRS","2026-05-13",{"date":418,"type":50},"2026-05-14",{"date":420,"type":50},"2026-05-11",{"date":422,"type":22},"2029-05-11",{"name":350,"class":57},{"id":425,"slug":426,"hasResults":12,"nctId":427,"briefTitle":428,"officialTitle":429,"acronym":430,"eligibilityCriteria":431,"healthyVolunteers":432,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":433,"targetDuration":4,"studyType":23,"phases":435,"briefSummary":436,"conditions":437,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":438,"lastUpdatePostDateStruct":439,"startDateStruct":440,"completionDateStruct":442,"leadSponsor":444,"locationsCount":4},"100632919","promoting-change-in-practice-for-respiratory-failure-100632919","NCT07519941","Promoting Change in Practice for Respiratory Failure","Promoting Change in Practice for Respiratory Failure: the PRECIPICE Study","PRECIPICE","Inclusion Criteria:\n\n* We will include physicians, nurses, and other staff at participating ICUs who consent to participate.\n\nExclusion Criteria:\n\n* We will exclude potential participants who cannot speak either English or Spanish.",true,{"count":434,"type":22},20,[25],"Approximately 300,000 Hispanic individuals experience respiratory failure each year in the U.S. Hispanic patients are twice as likely to die from respiratory failure as non-Hispanic patients. There is an urgent need to identify and remediate mechanisms that increase risk of death from respiratory failure. The team's preliminary work identified two potential mechanisms: Hispanic patients with respiratory failure are more likely to be deeply sedated and less likely to receive physical therapy than non-Hispanic patients, which are both associated with mortality and poor long-term functional outcomes. The overall objective of this proposal is to improve outcomes for patients with respiratory failure through changes in intensive care unit (ICU) practice. This trial will refine and pilot an intervention to promote guideline-concordant care. The team's preliminary intervention will be iteratively refined through patient, family, and clinician engagement and piloted at two U.S. ICUs. The outcome of this study will be an intervention aimed at reducing mortality from respiratory failure.",[28],"2026-05-07",{"date":420,"type":50},{"date":441,"type":22},"2026-08-01",{"date":443,"type":22},"2027-04-01",{"name":445,"class":57},"New York University",{"id":447,"slug":448,"hasResults":12,"nctId":449,"briefTitle":450,"officialTitle":450,"acronym":451,"eligibilityCriteria":452,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":453,"targetDuration":4,"studyType":23,"phases":455,"briefSummary":456,"conditions":457,"keywords":459,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":513,"lastUpdatePostDateStruct":514,"startDateStruct":515,"completionDateStruct":516,"leadSponsor":518,"locationsCount":520},"100635867","win-ratio-analysis-to-determine-a-strategy-of-non--invasive-support-for-respiratory-failure-in-the-emergency-department-100635867","NCT07558265","WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department","WINDSURFER","Inclusion Criteria:\n\n* Age ≥18 years\n* Presenting to the Emergency Department (ED) with Acute Hypoxemic Respiratory failure (AHRF), defined as:\n\n  * \\[(respiratory rate ≥25 breaths\u002Fmin) AND (requiring ≥6 L\u002Fmin of oxygen required to maintain SpO2 ≥90%), OR SpO2:FiO2 ratio\\\u003C250\\] OR\n  * Arrival at ED on prehospital Non-Invasive Respiratory Support (NIRS).\n* Clinical need for NIRS\n* Randomization ≤2 hours after identification of need for NIRS\n* Randomization ≤6 hours of ED arrival\n\nExclusion Criteria:\n\n* Urgent need for intubation\n* Cardiac arrest\n* Respiratory arrest\n* Patient not located in the ED\n* Craniofacial anatomic features that prohibit either Non-Invasive Positive Pressure Ventilation (NIPPV) or High Flow Nasal Oxygen (HFNO) interface\n* Tracheostomy or laryngectomy stoma\n* Hemodynamic instability requiring \\>0.2mcg\u002Fkg\u002Fmin of norepinepherine (or equivalent) to maintain mean arterial pressure \\>65mmHg\n* Pre-existing \"do not resuscitate\" or \"do not intubate\" order\n* Home use of non-invasive positive-pressure ventilation for respiratory support of a medical condition other than sleep apnea\n* Transferred from another Emergency Department\n* History of advanced chronic obstructive pulmonary disease\n* History of advanced heart failure\n* Presence of opt-out identification\n* Prisoner\n* Known or apparent pregnant\n* Previous enrollment in WINDSURFER\n* A patient-specific contraindication makes one assigned study intervention unsafe",{"count":454,"type":22},500,[25],"The purpose of this clinical trial is to determine the best initial non-invasive respiratory support (NIRS) strategy for adults who present to the emergency department with acute hypoxemic respiratory failure, a condition in which blood oxygen levels are dangerously low and require urgent treatment. This study compares two commonly used non-invasive respiratory support strategies to evaluate their effectiveness and safety, based on important patient outcomes during hospitalization, including survival, the need for invasive mechanical ventilation, and the duration of respiratory support. Participants will be randomly assigned (with an equal chance) to receive one of the following treatments:\n\n* Non-Invasive Positive Pressure Ventilation (NIPPV): Oxygen delivered under pressure through a face mask.\n* High-Flow Nasal Oxygen (HFNO): Oxygen delivered at high-flow through a specially designed nasal cannula placed in the nostrils.\n\nResearchers will compare the two treatment strategies using a hierarchical assessment of major pulmonary outcomes, including:\n\n* Hospital survival\n* Days on mechanical ventilation\n* Duration of non-invasive respiratory support\n\nAs part of the study, researchers will collect:\n\n* Blood and urine samples\n* Physiologic measurements (such as chest movement measured through sensors placed on the skin)\n* Information from participants' medical records",[458,28],"Acute Hypoxic Respiratory Failure",[460,461,36,462,463,464,387,465,466,467,468,469,470,471,472,473,474,475,476,477,478,335,479,480,481,482,483,484,485,486,487,488,489,490,491,492,493,494,495,496,497,498,499,500,501,502,503,504,505,506,507,508,451,509,510,511,512],"Acute Hypoxemic Respiratory Failure","Acute Decompensated Heart Failure","BiPAP","BPAP","COPD","Continuous Positive Airway Pressure","HFNO","High-Flow Nasal Oxygen","EPAP","Expiratory Positive Airway Pressure","FiO2","Inspired Oxygen Fraction","IMV","Invasive Mechanical Ventilation","IPAP","Inspiratory Positive Airway Pressure","MAPE","Major Adverse Pulmonary Events","MV","NIRS","Non-Invasive Respiratory Support","NIPPV","Non-Invasive Positive Pressure Ventilation","PaCO2","Partial pressure of carbon dioxide in arterial blood","PaO2","Partial pressure of oxygen in arterial blood","P:F","Ratio of PaO2 to FiO2","RR","Respiratory Rate","P-SILI","Patient Self-Inflicted Lung Injury","RRT","Renal Replacement Therapy","RSFD","Respiratory Support Free Days","S:F","Ratio of SpO2 to FiO2","SpO2","Transcutaneous measurement of peripheral arterial saturation","UADE","Unanticipated Adverse Device Effects","VAS","Visual Analog Scale","VDays","Ventilator Days","VFD","Ventilator-Free Days","WIN ratio analysis to determine a strategy of non-invasive support for respiratory failure in the emergency department trial","WR","WIN Ratio","Bilevel Positive Airway Pressure","2026-05-05",{"date":438,"type":50},{"date":267,"type":22},{"date":517,"type":22},"2031-08",{"name":519,"class":57},"Ohio State University",2,{"id":522,"slug":523,"hasResults":12,"nctId":524,"briefTitle":525,"officialTitle":526,"acronym":527,"eligibilityCriteria":528,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":529,"targetDuration":4,"studyType":23,"phases":531,"briefSummary":532,"conditions":533,"keywords":534,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":513,"lastUpdatePostDateStruct":542,"startDateStruct":544,"completionDateStruct":546,"leadSponsor":548,"locationsCount":550},"100445032","phase-3-pirfenidone-to-prevent-fibrosis-in-ards-100445032","NCT05075161","Pirfenidone to Prevent Fibrosis in Ards.","Pirfenidone to Prevent Fibrosis in ARDS. A Randomized Controlled Trial - PIONEER","PIONEER","Inclusion Criteria:\n\nConcomitant presence of:\n\n* ARDS (moderate and severe) - Berlin definition\n\n  1. Within 1 week of a known clinical insult or new or worsening respiratory symptoms\n  2. Bilateral opacities on CXR which are not fully explained by effusions, lobar\u002Flung collapse or nodules\n  3. Respiratory failure not fully explained by cardiac failure or fluid overload\n  4. PaO2\u002FFiO2\\\u003C200 mmHg with PEEP\\\u003C=5 cmH2O (invasive mechanical ventilation)\n* Inflammatory ARDS phenotype (28), defined by at least one of the following:\n\n  1. High plasma levels of inflammatory biomarkers\n  2. Vasopressor dependence\n  3. Lower serum bicarbonate or increased serum lactate\n* Informed consent expressed by the patient or by legal representative or on the Ethical Committee indication.\n* Age \\>=18 years\n\nExclusion Criteria:\n\n* Intubated and mechanically ventilated via an endotracheal or tracheostomy tube (\\>7 days) up to the time of randomization\n* ARDS severe or moderate for more than 36 hours\n* Untreated pulmonary embolism, pleural effusion or pneumothorax as the primary cause of ARF\n* ARF fully explained by left ventricular failure or fluid overload\n* Consent declined\n* Severe chronic respiratory disease requiring domiciliary ventilation\n* Clinical suspicion for significant restrictive lung disease\n* Pregnant women or women of childbearing potential who are sexually active\n* Known allergy to pirfenidone\n* Concomitant use of fluvoxamine\n* Known severe hepatic failure\n* Known severe renal failure or necessity of dialysis not related to acute disease\n* Little chance of survival (SAPS II score\\>75)",{"count":530,"type":22},130,[282],"Acute respiratory distress syndrome (ARDS) is a severe form of acute lung injury and a major cause of Intensive Care Unit (ICU) admission worldwide. Despite a large number of randomized clinical trials, a specific and effective pharmacological approach for patients with ARDS is still lacking.\n\nFibroproliferation is a crucial part of the host defence response, and severe fibrotic lung disease affects ARDS patients even years after acute phase resolution.\n\nPirfenidone is an oral anti-fibrotic drug, approved and largely used for treatment of idiopathic pulmonary fibrosis (IPF). The effect of Pirfenidone in ARDS has been evaluated only in animal models.\n\nThis is a randomized controlled study to evaluate for the first time the efficacy of Pirfenidone in ARDS.",[28],[35,535,335,536,537,538,539,540,541],"Pulmonary Fibrosis","Antifibrotic drug","Intensive Care Unit","ICU discharge","Mortality","Spirometry","Quality of life",{"date":543,"type":50},"2026-05-08",{"date":545,"type":50},"2022-06-01",{"date":547,"type":22},"2026-12",{"name":549,"class":57},"Università Vita-Salute San Raffaele",17,{"id":552,"slug":553,"hasResults":12,"nctId":554,"briefTitle":555,"officialTitle":555,"acronym":4,"eligibilityCriteria":556,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":19,"enrollmentInfo":557,"targetDuration":559,"studyType":202,"phases":4,"briefSummary":560,"conditions":561,"keywords":562,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":566,"lastUpdatePostDateStruct":567,"startDateStruct":569,"completionDateStruct":571,"leadSponsor":573,"locationsCount":4},"100634866","effect-of-positive-end-expiratory-pressure-titration-on-venous-excess-ultrasound-score-and-renal-outcomes-in-patients-with-acute-respiratory-distress-syndrome-100634866","NCT07545252","Effect of Positive End-Expiratory Pressure Titration on Venous Excess Ultrasound Score and Renal Outcomes in Patients With Acute Respiratory Distress Syndrome","Inclusion Criteria:\n\n* Age ≥18 years.\n* Diagnosis of ARDS according to the Berlin criteria.\n* Invasive mechanical ventilation ≥24 hours.\n* Requirement of PEEP ≥5 cmH₂O.\n\nExclusion Criteria:\n\n* Known end-stage renal disease on chronic dialysis.\n* History of renal transplantation.\n* Pregnancy.\n* Known severe tricuspid regurgitation.\n* Chronic liver disease with portal hypertension.\n* Poor ultrasound window precluding adequate venous Doppler assessment.",{"count":558,"type":22},40,"3 Days","This study is a prospective observational cohort study conducted planned to include 40 patients with ARDS to assess the effect of different levels of PEEP titration on VExUS score and renal outcomes in patients with Acute Respiratory Distress Syndrome.",[28],[35,563,564,565],"mechanically ventilatuon","PEEP Titration","VExUS","2026-04-16",{"date":568,"type":50},"2026-04-22",{"date":570,"type":22},"2026-04-12",{"date":572,"type":22},"2026-10-12",{"name":574,"class":57},"Fayoum University",{"id":576,"slug":577,"hasResults":12,"nctId":578,"briefTitle":579,"officialTitle":579,"acronym":4,"eligibilityCriteria":580,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":581,"targetDuration":582,"studyType":202,"phases":4,"briefSummary":583,"conditions":584,"keywords":587,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":596,"lastUpdatePostDateStruct":597,"startDateStruct":599,"completionDateStruct":601,"leadSponsor":603,"locationsCount":58},"100634644","the-feasibility-of-pulmonary-perfusion-assessment-using-sodium-bicarbonate-contrast-with-electrical-impedance-tomography-a-prospective-pilot-study-100634644","NCT07542366","The Feasibility of Pulmonary Perfusion Assessment Using Sodium Bicarbonate Contrast With Electrical Impedance Tomography: A Prospective Pilot Study","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Admitted to the intensive care unit (ICU)\n* Receiving invasive mechanical ventilation with controlled or assisted-controlled mode\n* Presence of a central venous catheter suitable for contrast bolus injection\n* Hemodynamically stable (no ongoing cardiopulmonary resuscitation; no uncontrolled shock judged by treating physician)\n* Expected to remain on mechanical ventilation for the duration of the EIT examination\n* Written informed consent obtained from the patient or legally authorized representative\n\nExclusion Criteria:\n\n* Known pregnancy\n* Known allergy, intolerance, or contraindication to sodium bicarbonate or hypertonic saline\n* Severe arrhythmia or unstable cardiovascular status in which small bolus injection is deemed unsafe by the treating physician\n* Uncontrolled agitation or conditions that preclude correct EIT belt placement (e.g., extensive chest wounds, large chest dressings, chest wall deformity that prevents belt use)\n* Implanted electronic devices or metallic implants in the thoracic area considered a contraindication to EIT by the manufacturer's instructions\n* End-stage disease with expected survival of only a few hours, in whom participation is not appropriate as judged by the treating physician\n* Participation in another interventional trial that, in the opinion of the investigator, could interfere with EIT measurements or safety assessment",{"count":117,"type":22},"28 Days","The goal of this observational pilot study is to learn if sodium bicarbonate can be used safely and effectively as a contrast agent to map lung blood flow using electrical impedance tomography (EIT) in adults on mechanical ventilation. Electrical impedance tomography (EIT) is a bedside imaging method that uses a soft belt with small sensors around the chest to track changes in electrical signals related to breathing and blood flow.\n\nThe main questions are:\n\nDoes sodium bicarbonate create clear, readable lung blood flow images with EIT? Are these images similar in quality and pattern to images made with hypertonic saline (10% sodium chloride)? Is the short-term safety profile acceptable, including effects on blood pressure, heart rhythm, and blood tests?\n\nResearchers will compare two contrast agents within the same participant to see if image quality and lung blood flow patterns match:\n\nHypertonic saline (10% sodium chloride) Sodium bicarbonate (5%)\n\nParticipants will:\n\nHave an EIT belt placed around the chest during routine ICU care Pause the ventilator briefly during image capture to reduce motion Receive two small intravenous boluses through an existing central line, one of hypertonic saline and one of sodium bicarbonate, with time between doses Have routine monitoring of vital signs; blood gases and electrolytes may be checked per clinical care Be observed for any short-term side effects Findings from this study will show whether sodium bicarbonate is a practical and safe option for EIT-based lung blood flow assessment and will guide larger future studies.",[106,28,38,585,586],"Critical Illness","Feasibility of Contrast-enhanced Electrical Impedance Tomography (EIT) for Pulmonary Perfusion Assessment in Mechanically Ventilated Adults",[261,588,589,590,591,592,335,593,594,595],"Pulmonary Perfusion","Contrast-Enhanced EIT","Sodium Bicarbonate Contrast","Hypertonic Saline (10% NaCl)","First-Pass Impedance Signal","Intensive Care Unit (ICU)","Ventilation-Perfusion (V\u002FQ) Matching","Feasibility Study","2026-04-14",{"date":598,"type":50},"2026-04-21",{"date":600,"type":50},"2024-09-26",{"date":602,"type":22},"2026-09-25",{"name":604,"class":57},"First Affiliated Hospital of Wannan Medical College",{"id":606,"slug":607,"hasResults":12,"nctId":608,"briefTitle":609,"officialTitle":609,"acronym":610,"eligibilityCriteria":611,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":612,"targetDuration":4,"studyType":23,"phases":614,"briefSummary":615,"conditions":616,"keywords":617,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":620,"lastUpdatePostDateStruct":621,"startDateStruct":622,"completionDateStruct":623,"leadSponsor":625,"locationsCount":4},"100632667","ultraprotective-lung-ventilation-with-respiratory-extracorporeal-life-support-for-ards-100632667","NCT07516665","Ultraprotective Lung Ventilation With Respiratory Extracorporeal Life Support for ARDS","NOVAEOLIA","Inclusion Criteria:\n\n1. Intubation and Invasive mechanical ventilation ≤ 7 days\n2. Presence of all of the following conditions for ≤48 hours:\n\n   * 80 ≤ PaO2\u002FFiO2 ≤300 with PEEP \\>5 cmH2O\n   * Bilateral opacities not fully explained by effusions, lobar\u002Flung collapse, or nodules\n   * Respiratory failure not fully explained by cardiac failure or fluid overload\n3. One of the following criteria (with Vt set at 6 mL\u002Fkg PBW):\n\n   * DeltaP ≥15 cm H2O OR\n   * Ventilatory ratio ≥2.2\n4. Signed Informed consent from a close relative or surrogate or a family member. According to the specifications of emergency inclusion, randomization without the close relative\u002Fsurrogate consent could be performed if the patient is unable to give his\u002Fger consent and when the close relative\u002Fsurrogate\u002Ffamily member are absent. Close relative\u002Fsurrogate\u002Ffamily member consent will be asked as soon as possible after randomization. The patient will be asked as soon as possible to give his\u002Fher consent for the continuation of the trial when his\u002Fher condition will allow.\n5. Social security registration (AME excluded)\n\nExclusion Criteria:\n\n1. Age \\\u003C18 years\n2. Pregnancy or breastfeeding\n3. Catheter access to femoral vein or jugular vein impossible\n4. Expected duration of mechanical ventilation \\\u003C 48 hours\n5. Chronic restrictive or obstructive (COPD) respiratory insufficiency with home ventilation or oxygen therapy\n6. Currently receiving ECLS therapy\n7. Severe cardiac failure or ongoing acute coronary syndrome\n8. Heparin-induced thrombocytopenia\n9. Severe underlying pre-existing condition with expected six-month mortality \\>50%\n10. Contraindication for systemic anticoagulation (including platelet count \\\u003C50G\u002FL)\n11. Patient moribund, decision to limit therapeutic interventions\n12. Acute brain injury or irreversible neurological pathology\n13. Bone marrow transplantation within the last 1 year\n14. Actual body weight exceeding 1 kg per centimeter of height\n15. Prior enrolment in the trial",{"count":613,"type":22},290,[25],"Acute respiratory distress syndrome (ARDS) accounts for approximately 10% of all ICU admissions and 23% of patients requiring mechanical ventilation (MV). Despite advances in care, hospital mortality remains high, ranging from 34% in mild cases to 46% in severe ARDS. Positive-pressure MV remains the cornerstone of ARDS management. However, when excessive stress and strain are applied to the lung parenchyma, it can exacerbate lung injury, leading to ventilator-induced lung injury (VILI). VILI substantially contributes to morbidity and mortality in ARDS. Strategies that reduce tidal volume (Vt), driving pressure (ΔP, defined as plateau pressure minus PEEP), and respiratory rate (RR) can lower the mechanical power (PowerRS), i.e., the energy delivered to the lungs by the ventilator. This reduction in pulmonary stress and strain may lessen VILI and potentially improve survival. Nonetheless, reducing Vt to \\\u003C6 ml\u002Fkg in order to achieve plateau pressures \\\u003C23-25 cm H₂O, driving pressures \\\u003C9-11 cm H₂O, and RR \\\u003C15-20\u002Fmin can result in severe hypercapnia. This, in turn, may increase intracranial pressure, promote pulmonary hypertension, impair myocardial contractility, reduce renal perfusion, and trigger endogenous catecholamine release. Thus, such \"ultraprotective\" MV strategies are not feasible for most ARDS patients managed with conventional ventilation. The neutral findings of the REST trial further suggested that low-flow extracorporeal CO₂ removal (ECCO₂R) devices may provide insufficient CO₂ clearance to enable ultraprotective ventilation while adequately controlling respiratory acidosis. Moreover, since partial lung derecruitment may occur with substantial Vt reduction, extracorporeal membrane oxygenation (ECMO) may be necessary, particularly in patients with PaO₂\u002FFiO₂ \\\u003C120-130 at the time of Vt reduction. Therefore, respiratory extracorporeal life support (ECLS)-ranging from high-flow ECCO₂R to mid-flow venovenous ECMO (VV-ECMO)-can be employed in this setting. These modalities facilitate further reductions in ventilatory intensity while ensuring adequate oxygenation and CO₂ removal.",[28],[618,619],"ECLS","Acute Respiratory Distress Syndorme (ARDS)","2026-04-09",{"date":596,"type":50},{"date":420,"type":22},{"date":624,"type":22},"2028-08",{"name":350,"class":57},{"id":627,"slug":628,"hasResults":12,"nctId":629,"briefTitle":630,"officialTitle":631,"acronym":4,"eligibilityCriteria":632,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":633,"targetDuration":4,"studyType":23,"phases":634,"briefSummary":635,"conditions":636,"keywords":637,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":620,"lastUpdatePostDateStruct":641,"startDateStruct":642,"completionDateStruct":644,"leadSponsor":646,"locationsCount":4},"100457781","phase-2-multicentric-randomized-study-to-assess-safety-and-efficacy-of-centhaquine-in-patients-with-ards-100457781","NCT05241067","Multicentric, Randomized Study to Assess Safety and Efficacy of Centhaquine in Patients With ARDS","A Multicentric, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Centhaquine as an Adjuvant to the Standard of Care in Patients With Moderate to Severe Acute Respiratory Distress Syndrome (ARDS)","Inclusion Criteria:\n\nA subject will be eligible for inclusion in the study if he\u002Fshe fulfills the following criteria:\n\n1. Adult male or female aged 18 years or older\n2. Hospitalized in the ICU diagnosed with moderate to severe ARDS having a PaO2\u002FFiO2 ratio of \\\u003C 200 mmHg or the SPO2\u002FFiO2 ratio of ≤ 235( if SPO2 ≤ 97 %) with PEEP ≥ 5 cm H20 include the patient receiving invasive \u002Fnon-invasive ventilation (NIV\u002FCPAP).\n3. The first dose of the study drug should be administered within 48 hours of confirming moderate to severe ARDS.\n4. Requires vasopressor support\n5. Written informed consent\n\nExclusion Criteria:\n\nA subject will not be eligible for inclusion in this study if he\u002Fshe meets any of the following exclusion criteria:\n\n1. Receiving or expected to receive extracorporeal membrane oxygenation or high-frequency oscillatory ventilation\n2. Confirmed pregnancy\n3. Breast feeding\n4. Participating in another interventional study\n5. Requires or having the renal replacement therapy\n6. Hepatic failure (Child-Pugh scores B and C)",{"count":331,"type":22},[99],"Acute respiratory distress syndrome (ARDS) is a life-threatening condition with a diffuse, inflammatory form of lung injury, causing pulmonary infiltration and respiratory failure leading to poor oxygenation. It is a rapidly progressive form of respiratory failure and accounts for approximately 10% of admissions to the intensive care unit (ICU) and has a high mortality (40%) in severe cases. Globally, approximately 3 million ARDS cases are reported each year, with around 200,000 cases seen in the United States.\n\nThe etiology of ARDS could be pulmonary or extra-pulmonary. Patients with ARDS have symptoms like difficulty in breathing, shortness of breath, and cyanosis, and they may require assisted breathing\u002Fventilatory support\u002Fextracorporeal membrane oxygenation. About 25% of ARDS patients need mechanical ventilation to support breathing; however, a ventilator-induced lung injury (VILI) is known to further exacerbate ARDS in many of them. In recent decades, numerous efforts have been made to develop therapies for treating\u002Fmanaging ARDS. Unfortunately, they have been largely unsuccessful or inconclusive, and at present, no effective pharmacological therapy for ARDS is available. Hence, development of better therapeutics for ARDS is an unmet need.\n\nCenthaquine is a first-in-class resuscitative agent for hypovolemic shock approved for marketing in India. Centhaquine has been found to be an effective resuscitative agent in rat, rabbit, and swine models of hemorrhagic shock. Its safety and tolerability have been demonstrated in a human phase I study in 25 subjects (CTRI\u002F2014\u002F06\u002F004647). Results from multicentric, randomized, double-blind, parallel, controlled clinical phase II (CTRI\u002F2017\u002F03\u002F008184) and phase III (CTRI\u002F2019\u002F01\u002F017196) studies conducted in India indicate that centhaquine is a novel, first-in-class, highly effective resuscitative agent for hypovolemic shock. A total of 155 patients with hypovolemic shock have been studied in the combined phase II and III trials, while a multicentric phase IV study (NCT05956418) in 400 patients with hypovolemic shock is currently being conducted in India. The outcomes of the completed trials indicate that centhaquine is safe and reduces mortality significantly (P=0.0271) compared to standard treatment of hypovolemic shock. In the phase II and III studies, ARDS and MODS were evaluated as secondary endpoints. Centhaquine provided hemodynamic stability and significantly reduced ARDS and multiple organ dysfunction score (MODS) in patients enrolled in these trials, which suggests that centhaquine has potential beyond treating hypovolemic shock and could be useful for ARDS treatment. Centhaquine is likely to provide hemodynamic stability, improve tissue oxygenation, reduce pulmonary edema, reduce ARDS score, and reduce MODS in patients with ARDS.",[28],[35,638,639,640],"Resuscitation","Centhaquine","Hypoxia",{"date":596,"type":50},{"date":643,"type":22},"2026-05",{"date":645,"type":22},"2026-12-31",{"name":647,"class":116},"Pharmazz, Inc.",{"id":649,"slug":650,"hasResults":12,"nctId":651,"briefTitle":652,"officialTitle":653,"acronym":4,"eligibilityCriteria":654,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":655,"targetDuration":4,"studyType":202,"phases":4,"briefSummary":656,"conditions":657,"keywords":658,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":663,"lastUpdatePostDateStruct":664,"startDateStruct":666,"completionDateStruct":668,"leadSponsor":670,"locationsCount":672},"100631749","trunk-inclination-positive-end-expiratory-pressure-and-lung-recruitability-100631749","NCT07504731","Trunk Inclination, Positive End-expiratory Pressure, and Lung Recruitability","Impact of Trunk Inclination on Lung Mechanics According to PEEP and Reruitability","Inclusion Criteria:\n\n* Intubated moderate and severe ARDS according to the Berlin definition (PaO2\u002FFiO2 ratio \\\u003C= 200 mmHg)\n* Under continuous sedation with or without paralysis\n\nExclusion Criteria:\n\n* Age \\\u003C18 years\n* Bronchopleural fistula\n* Pure COPD exacerbation\n* Contraindication to EIT monitoring (e.g. burns, pacemaker, thoracic wounds limiting electrode belt placement)\n* Hemodynamic instability (Systolic BP \\\u003C 75 mmHg or MAP \\\u003C 60 mmHg despite vasopressors and\u002For heart rate \\\u003C 55 bpm)\n* Contraindications to mobilization (e.g., intracranial hypertension, spinal cord injury)\n* Intra-abdominal hypotension (IAP≥12mmHg)\n* Pregnancy\n* Attending physician deems the transient application of high airway pressures to be unsafe",{"count":558,"type":22},"This multicenter, physiological, observational study hypothesizes that in moderate to severe ARDS, trunk inclination unloads the chest wall, but its impact on lung mechanics depends on PEEP levels and lung recruitability.",[28],[659,660,661,662],"trunk inclination","lung mechanics","positive end-expiratory pressure","lung recruitability","2026-03-25",{"date":665,"type":50},"2026-04-01",{"date":667,"type":50},"2026-03-20",{"date":669,"type":22},"2027-04-30",{"name":671,"class":57},"Zhongda Hospital",3,{"id":674,"slug":675,"hasResults":12,"nctId":676,"briefTitle":677,"officialTitle":678,"acronym":679,"eligibilityCriteria":680,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":681,"targetDuration":4,"studyType":23,"phases":682,"briefSummary":683,"conditions":684,"keywords":685,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":691,"lastUpdatePostDateStruct":692,"startDateStruct":694,"completionDateStruct":695,"leadSponsor":697,"locationsCount":4},"100628611","spontaneous-vs-controlled-mechanical-ventilation-in-acute-hypoxemic-respiratory-failure-100628611","NCT07463885","Spontaneous vs Controlled Mechanical Ventilation in Acute Hypoxemic Respiratory Failure","Spontaneous Versus Controlled Mechanical Ventilation in Patients With Acute Hypoxemic Respiratory Failure: A Feasibility Study and Pilot Trial","SVALBARD","Inclusion Criteria:\n\nWe will include patients who fulfil all the following criteria:\n\n* Acutely admitted to the ICU\n* AND age ≥ 18 years\n* AND invasive mechanical ventilation via endotracheal tube or tracheostomy for less than 24 hours\n* AND moderate acute hypoxemic respiratory failure, defined as a PaO₂-FiO₂ ratio between 13.3-26.6 kPa (100-200 mmHg) with PEEP ≥ 5 cm H2O, based on arterial blood gas analysis obtained within 2 hours before randomisation.\n* AND new pulmonary infiltrate (uni- or bilateral) on chest x-ray or CT-scan obtained no more than 24 hours before randomisation.\n\nExclusion Criteria:\n\n* Previously randomised into the SVALBARD trial.\n* Informed consent following inclusion expected to be unobtainable\n* Patient under coercive measures\n* Withdrawal from active therapy or brain death deemed imminent.\n* Chronic hypercapnic respiratory failure defined as PaCO2 \\> 8 kPa (60 mm Hg) in the outpatient setting.\n* Listed for lung transplant.\n* Acute heart failure \u002F acute myocardial infarction \u002F cardiac arrest during or causing index ICU admission.\n* Use of home oxygen.\n* Chronic mechanical ventilation for any reason except for non-invasive mechanical ventilation (CPAP\u002FBIPAP) used solely for sleep apnoea disorder.\n* Currently receiving ECMO therapy.\n* Burns \\>70 % total body surface.\n* Acute brain injury or stroke (any, including subarachnoid haemorrhage, SAH).\n* Intracranial hypertension.\n* Patients with planned repeat surgical interventions during current stay in ICU.",{"count":331,"type":22},[25],"Acute hypoxemic respiratory failure may progress to acute respiratory distress syndrome, a life-threatening condition that often requires mechanical ventilation. The optimal ventilation strategy in this patient population remains uncertain.\n\nThe SVALBARD trial is a feasibility and pilot study designed to compare spontaneous versus controlled mechanical ventilation in patients with acute hypoxemia respiratory failure.\n\nThe primary objective is to assess the feasibility of the study procedures and interventions, while also collecting descriptive data on key clinical variables to inform the design of a future randomized controlled trial.",[28,460],[312,686,255,687,688,689,690],"Acute hypoxemic respiratory failure","assisted ventilation","controlled ventilation","feasibility trial","randomised clinical trial","2026-03-11",{"date":693,"type":50},"2026-03-13",{"date":52,"type":22},{"date":696,"type":22},"2028-03-30",{"name":698,"class":57},"Oslo University Hospital"]