[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"septic-shock\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:septic-shock":29},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,152,0,25,[9,45,70,100,126,154,178,205,226,259,285,308,334,361,384,404,427,445,472,496,515,539,559,586,614],{"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":30,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100652974","personalized-fluid-resuscitation-in-the-emergency-department-a-pilot-trial-100652974",false,"NCT07779720","Personalized Fluid Resuscitation in the Emergency Department: A Pilot Trial","Personalized Fluid Resuscitation for Improved Sepsis Resuscitation Quality in the Emergency Department","FLUID-ED","Inclusion Criteria:\n\n1. Adult patient being treated in the Intermountain Medical Center ED\n2. Patient has suspected sepsis. Suspected sepsis can be identified by a positive sepsis screen (standard screen completed by ED triage nurse), an active sepsis alert (which is triggered based on qualifying information or active by an ED nurse), or clinician report that patient has possible sepsis\n3. Patient is hypotensive OR has an initial lactate ≥4 mmol\u002FL at the time of enrollment. Hypotension is defined as mean arterial pressure (MAP) \\\u003C65 mmHg or systolic blood pressure (SBP) \\\u003C90mmHg or patient is on vasopressors at time of enrollment.\n\nExclusion Criteria:\n\n1. Age \\\u003C 18 years\n2. Known pregnant patients\n3. Patients who are known to be incarcerated\n4. A trained and delegated study team member is not available to perform the NICOM fluid assessment\n5. Patient has been in the ED for \\>6 hours or was transferred from an outside ED\n6. Patient has already received 30 ml\u002Fkg IV fluid or has this fluid volume ordered. Weight-based fluid dosing is calculated based on actual body weight for BMI \\\u003C30kg\u002Fm2 and ideal body weight for BMI ≥30 kg\u002Fm2\n7. Known clinical diagnosis of a condition potentially altering risk\u002Fbenefit profile of NICOM-based fluid assessment, which may include\n\n   1. Hemorrhagic shock (i.e.., active hemorrhage)\n   2. Cardiogenic shock (i.e., hypotension suspected to be due to left or right ventricular failure)\n   3. Obstructive shock (i.e., shock in the setting of known acute central pulmonary embolism, pneumothorax, or pericardial effusion)\n   4. Active volume loss that requires fluid replacement per the treating clinician (i.e., injury due to burn)\n   5. Acute stroke\n   6. Acute myocardial infarction\n   7. Status asthmaticus\n   8. Status epilepticus\n   9. Presence of a left ventricular assist device (LVAD)\n   10. Severe aortic insufficiency\n8. Known clinical contraindication to passive leg raise.\n\n   1. Lower extremity amputation\n   2. Lower extremity trauma\n   3. Open abdomen\n   4. Suspected or known elevated intracranial pressure, for example from intracranial hemorrhage, tumor, or traumatic brain injury\n   5. Contraindication to lying flat\n   6. Inability to cooperate with the maneuver (e.g., severe pain, agitation).\n9. Contraindication to non-invasive cardiac output monitoring (NICOM) lead placement.\n\n   1. Allergy to adhesive used in the NICOM lead stickers\n   2. Skin breakdown precluding lead placement on the patient's chest and back\n10. Treating clinician determines that NICOM assessment is either required or contraindicated for the optimal care of the patient","ALL","18 Years",{"count":21,"type":22},40,"ESTIMATED","INTERVENTIONAL",[25],"NA","The goal of this pilot clinical trial is to learn if a fluid assessment using non-invasive cardiac output monitoring (NICOM) is helpful for patients with sepsis who have low blood pressure in the Emergency Department (ED). The study will measure whether the NICOM assessment changes fluid resuscitation practices and is feasible in the ED setting. All patients will receive standard medical care. Patients assigned to the NICOM group will receive a one-time, non-invasive bedside fluid assessment using NICOM, in addition to standard care, and the results of the fluid assessment will be provided to the treating physician.",[28,29],"Sepsis","Septic Shock",[28,31],"septic shock","RECRUITING","2026-08-19",{"date":35,"type":36},"2026-08-21","ACTUAL",{"date":38,"type":22},"2026-08",{"date":40,"type":22},"2028-05-01",{"name":42,"class":43},"Intermountain Health Care, Inc.","OTHER",1,{"id":46,"slug":47,"hasResults":12,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":23,"phases":55,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":44},"100609401","phase-2-phase-iib-multicenter-randomized-controlled-trial-evaluating-the-efficacy-of-sivelestat-in-patients-with-septic-coagulopathy-100609401","NCT07214103","Phase IIb Multicenter Randomized Controlled Trial Evaluating the Efficacy of Sivelestat in Patients With Septic Coagulopathy","SivelSep","Inclusion Criteria:\n\n* Adults aged 18 to 85 years\n* Patient (male or female) admitted to the ICU with:\n\n  * Septic shock defined by Sepsis-3 criteria: acute, life-threatening organ dysfunction related to a suspected or confirmed infection, requiring vasopressor support to maintain a mean arterial pressure ≥ 65 mmHg and a serum lactate level \\> 2 mmol\u002FL despite adequate fluid resuscitation.\n  * Coagulopathy defined by a SIC score ≥ 4 points.\n* Randomization within 12 hours after the diagnosis of coagulopathy (positive SIC score).\n* Patient affiliated with a national health insurance system.\n* Written informed consent: freely given, dated, and signed.\n\n  * By the patient\n  * Or by a legal representative if the patient is unable to provide consent.\n  * Or through an emergency inclusion procedure if the patient is unable to consent and no family member is available\n\nExclusion Criteria:\n\n* History of hypersensitivity reaction to Sivelestat (the only contraindication for Sivelestat)\n* Patient weight \\> 100 kg\n* Severe chronic liver disease (Child-Pugh C)\n* Contraindication to the use of unfractionated heparin\n* Moribund patient at the time of randomization\n* Limitation of active therapeutic interventions at the time of study inclusion\n* Under legal protection (guardianship, curatorship, or legal safeguard)\n* Pregnancy or breastfeeding\n* Participation in another interventional drug clinical trial","85 Years",{"count":54,"type":22},120,[56],"PHASE2","Sepsis-induced disseminated intravascular coagulation (DIC) is a severe complication occurring in one-third of patients with septic shock, for which no specific treatment currently exists. It results from excessive systemic activation of coagulation and impaired fibrinolysis, leading to the development of disseminated microthromboses. We have recently demonstrated: 1) the contribution of NETs to the hypercoagulability observed in DIC, and 2) the role of neutrophil elastase-bound to NET DNA-in degrading plasminogen, a key factor limiting fibrinolysis and thus preventing the lysis of microthrombi in DIC.\n\nSivelestat is a neutrophil elastase inhibitor used in Japan for the treatment of acute respiratory distress syndrome (ARDS). It has the potential to inhibit: 1) neutrophil activation and the release of inflammatory mediators, and 2) plasminogen degradation, which drives fibrinolytic failure. A recent meta-analysis including 2,050 patients across 15 studies showed that Sivelestat reduced ARDS patient mortality at day 28-30 (RR = 0.81, 95% CI = 0.66-0.98, p = 0.03), decreased mechanical ventilation duration and ICU length of stay, and improved oxygenation.\n\nWe propose to conduct a multicenter, double-blind, placebo-controlled phase IIb trial evaluating the efficacy of Sivelestat in restoring fibrinolysis in patients with septic shock complicated by coagulopathy, defined by a positive SIC score (≥ 4 points).",[29,59],"Coagulopathy","NOT_YET_RECRUITING","2026-08-18",{"date":63,"type":36},"2026-08-20",{"date":65,"type":22},"2027-08-01",{"date":67,"type":22},"2032-12-31",{"name":69,"class":43},"University Hospital, Strasbourg, France",{"id":71,"slug":72,"hasResults":12,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":80,"phases":4,"briefSummary":81,"conditions":82,"keywords":83,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":44},"100652357","discordance-between-capillary-refill-time-and-oxygen-extraction-ratio-in-septic-shock-100652357","NCT07774962","Discordance Between Capillary Refill Time and Oxygen Extraction Ratio in Septic Shock","Discordance Between Capillary Refill Time and Oxygen Extraction Ratio in Septic Shock: A Prospective Observational Cohort Study Evaluating Its Prevalence and Prognostic Value","DISCO-SHOCK","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Diagnosis of septic shock according to the Surviving Sepsis Campaign (SSC) 2026 guideline\n* Presence of both a central venous catheter and an arterial line\n\nExclusion Criteria:\n\n* Active bleeding\n* Ongoing extracorporeal membrane oxygenation (ECMO)\n* Raynaud phenomenon or significant peripheral vascular disease that makes capillary refill time measurement unreliable (e.g., critical ischemia, amputation, digital ulcer\u002Fnecrosis, or inability to measure on the right index finger)\n* Death within the first 6 hours\n* Inability to obtain hour-6 CRT or blood gas (phenotyping not possible)",{"count":79,"type":22},100,"OBSERVATIONAL","In septic shock, restoring large-vessel (macrocirculatory) perfusion-reflected by a normal capillary refill time (CRT)-does not always mean that oxygen use at the tissue level has recovered. This mismatch, sometimes called loss of hemodynamic coherence, may be detectable by comparing CRT with the oxygen extraction ratio (O₂ER), a marker of how much oxygen the tissues are extracting from the blood. Patients whose CRT has normalized but whose O₂ER remains abnormal-either too high (suggesting oxygen delivery that is insufficient for demand) or too low (suggesting microcirculatory shunting)-are considered to have a \"discordant\" perfusion phenotype.\n\nThis prospective, single-center, observational cohort study aims to determine how often this CRT-O₂ER discordance occurs at the 6th hour of resuscitation in adult patients with septic shock, and whether it is associated with 28-day mortality. Approximately 100 consecutive adult patients diagnosed with septic shock (with pre-existing central venous and arterial catheters) will be followed. Clinical and laboratory measurements-including CRT, O₂ER, lactate, mottling score, and organ dysfunction scores-will be recorded at hours 0, 6, 12, and 24, with the main phenotype grouping performed at hour 6. The study is purely observational: CRT is a painless, non-invasive bedside measurement, and O₂ER is calculated from blood gas samples already drawn as part of routine care, so no additional interventions or blood draws are performed for research purposes.",[29,28],[84,85,86,87,88,89,90,91],"Capillary Refill Time","Oxygen Extraction Ratio","Tissue Perfusion","ScvO2","Microcirculation","Hemodynamic Coherence","Lactate","Observational Cohort Study","2026-08-15",{"date":33,"type":36},{"date":95,"type":22},"2026-08-17",{"date":97,"type":22},"2027-07-17",{"name":99,"class":43},"Istanbul University - Cerrahpasa",{"id":101,"slug":102,"hasResults":12,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":108,"targetDuration":110,"studyType":80,"phases":4,"briefSummary":111,"conditions":112,"keywords":114,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":44},"100384663","impact-of-metabolite-supplementation-to-restore-mitochondrial-dysfunction-during-septic-shock-a-preclinical-study-100384663","NCT04288635","Impact of Metabolite Supplementation to Restore Mitochondrial Dysfunction During Septic Shock: a Preclinical Study","Impact of Metabolite Supplementation to Restore Mitochondrial Dysfunction During Septic Shock: a Preclinical Study: MEFDASE Study","MEFDASE","Inclusion Criteria:\n\n* All patients aged 18 or more\n* Patients with criteria for septic shock according to SEPSIS 3 definition (presumed sepsis, with persisting hypotension requiring vasopressors to maintain mean arterial pressure \\> 65 mmHg and having a serum lactate \\> 2 mmol\u002FL despite adequate fluid expansion).\n* Admitted in the ICU of Angers University Hospital\n\nExclusion Criteria:\n\n* Minor patients (aged less 18)\n* Patient subject to legal protection measures\n* Refusal of the patient or his family\n* Preexisting mitochondrial disease\n* Patient with aplasia\n* Pregnant or parturient women",{"count":109,"type":22},55,"28 Days","Septic shock is defined as a subset of sepsis with severe metabolism alterations, leading to organ failure. Septic shock is associated with a high mortality, around 40% according to the SEPSIS 3 definition.\n\nMetabolic alterations are responsible for lactic acidosis, and results in mitochondrial dysfunction.\n\nThis study aims at evaluate the impact of exogenous metabolites on restoring mitochondrial function in septic shock patients with lactate acidosis.\n\nMitochondrial metabolism (quantitative analysis, mitochondrial function) in intact Peripheral Blood Mononuclear Cells (PBMC) will be isolate and analyse from patients at the early phase of septic shock (admission), at day 2 and 4. Participant's medical history will be recorded: renal and liver metabolism, severity scores and outcomes and the need for supportive care in the intensive care unit (ICU) until 28 days after admission.\n\nFurthermore, the investigators will evaluate wether selected metabolites added to the cell culture medium may improve mitochondrial metabolism.",[29,113],"Multiple Organ Failure",[115],"mitochondrial dysfunction","2026-08-06",{"date":118,"type":36},"2026-08-10",{"date":120,"type":36},"2020-07-09",{"date":122,"type":22},"2027-08-09",{"name":124,"class":125},"University Hospital, Angers","OTHER_GOV",{"id":127,"slug":128,"hasResults":12,"nctId":129,"briefTitle":130,"officialTitle":130,"acronym":131,"eligibilityCriteria":132,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":133,"enrollmentInfo":134,"targetDuration":4,"studyType":23,"phases":136,"briefSummary":137,"conditions":138,"keywords":139,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":44},"100650293","value-of-biomarkers-of-brain-injury-for-predicting-psycho-cognitive-sequelae-secondary-to-sepsis-a-prospective-multicenter-study-100650293","NCT07746050","Value of Biomarkers of Brain Injury for Predicting Psycho-cognitive Sequelae Secondary to Sepsis: a Prospective Multicenter Study","SEPSYM","Inclusion Criteria:\n\n* Adults aged 18-80 years.\n* Admission to a medical or mixed ICU.\n* Sepsis or septic shock according to Sepsis-3 criteria.\n* ICU admission for less than 24 hours.\n* Need for invasive or non-invasive mechanical ventilation and\u002For vasopressor support.\n* Informed consent obtained from the patient or legal representative.\n\nExclusion Criteria:\n\n* Moribund patients.\n* Age \\>80 years.\n* Patients under legal guardianship.\n* History of schizophrenia or bipolar disorder.\n* Pregnancy.\n* No health insurance coverage.\n* Previous inclusion in the study.\n* Refusal to participate.","80 Years",{"count":135,"type":22},210,[25],"To evaluate the value of biomarkers of neuronal and glial injury for predicting cognitive impairment (memory impairment assessed by a MoCA score \\\u003C 26\u002F30) at 3 months in patient admitted in the intensive care unit for a sepsis or a septic shock.",[28,29],[28,140,141,142,143,144],"Delirium","Post intensive care syndrome","Biomarkers","NSE","NFL","2026-08-03",{"date":147,"type":36},"2026-08-04",{"date":149,"type":22},"2026-09",{"date":151,"type":22},"2028-08",{"name":153,"class":43},"Assistance Publique - Hôpitaux de Paris",{"id":155,"slug":156,"hasResults":12,"nctId":157,"briefTitle":158,"officialTitle":158,"acronym":4,"eligibilityCriteria":159,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":160,"enrollmentInfo":161,"targetDuration":4,"studyType":80,"phases":4,"briefSummary":163,"conditions":164,"keywords":166,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":44},"100649568","immune-dysregulation-during-sepsis-a-natural-history-cohort-100649568","NCT07735741","Immune Dysregulation During Sepsis: A Natural History Cohort","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n* Age \\>= 18 years old\n* Admitted to INOVA Fairfax Hospital\n* Meets sepsis-3 definition of sepsis in the last 48 hours\n\n  * Suspected infection\n  * Evidence of organ dysfunction (SOFA score \\>= 2)\n* Ability of subject or LAR to understand and the willingness to sign a written informed consent document\n\nEXCLUSION CRITERIA:\n\nAny individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Hemoglobin \\\u003C 7 microgram\u002FdL at the time of enrollment\n* Hemoglobin \\\u003C10 microgram\u002FdL in patients with known coronary artery disease or active EKG changes consistent with acute ischemia\n* Currently receiving infusion of epinephrine; or dopamine at an infusion rate of \\> 2.5\n\nmicrogram\u002Fkg\u002Fmin, norepinephrine of \\> 20 mircogram\u002Fmin, or vasopressin \\> 0.04 units\u002Fmin\n\n* Neutropenia (absolute neutrophil count less than 1000 cells\u002Fmicroliter)\n* Baseline cognitive impairment\n* Pregnancy","100 Years",{"count":162,"type":22},500,"Background:\n\nSepsis is an illness that occurs when the body s immune system runs out of control. This can damage organs. Sepsis causes an estimated 1 in 5 deaths worldwide. In this natural history study, researchers want to learn more about how the immune system changes during sepsis. They hope this knowledge will help them find better ways to treat sepsis.\n\nObjective:\n\nTo understand how sepsis affects the body over time.\n\nEligibility\n\nPeople aged 18 years and older admitted to INOVA Fairfax Hospital in Virginia and who have sepsis.\n\nDesign:\n\nResearchers will collect data from participants medical records.\n\nParticipants will have blood drawn at least 5 times while they are in the hospital. Blood may be collected for up to 30 days, if they remain in the hospital that long. The blood will be taken from access lines that are already in place. Some blood draws will be optional.\n\nParticipants may opt to have up to 3 tests of their heart function while they are in the hospital.\n\nSome participants may have a sample of fluid collected from their lungs.\n\nParticipants will have a follow-up visit about 90 days after they join the study. This visit will be by phone call if they have left the hospital. They will fill out a questionnaire. They will answer questions about their health and how they feel. The call will last about 30 minutes....",[28,29,165],"Sepsis-Associated Immune Dysregulation",[167],"SEPSIS","2026-07-29",{"date":170,"type":36},"2026-07-30",{"date":172,"type":22},"2027-01-01",{"date":174,"type":22},"2037-01-31",{"name":176,"class":177},"National Heart, Lung, and Blood Institute (NHLBI)","NIH",{"id":179,"slug":180,"hasResults":12,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":184,"eligibilityCriteria":185,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":186,"targetDuration":4,"studyType":23,"phases":188,"briefSummary":190,"conditions":191,"keywords":192,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":197,"startDateStruct":199,"completionDateStruct":200,"leadSponsor":202,"locationsCount":204},"100573474","phase-4-mechanistic-assessment-of-norepinephrine-therapy-vs-angiotensin-ii-in-septic-shock-100573474","NCT06746753","Mechanistic Assessment of Norepinephrine Therapy vs. Angiotensin-II in Septic Shock","Mechanistic Assessment of Norepinephrine TheRapy vs. Angiotensin-II in Septic Shock (MANTRA) Grant Submission- Dysfunctional Renin-Angiotensin System in Septic Shock","MANTRA","Inclusion Criteria:\n\n\\- The presence of septic shock, defined by sepsis-3 criteria: 1-adult patients (18 years or older) with septic shock, defined by SEPSIS-3 criteria: a) suspected or known infection, b) hypotension requiring vasopressors, and c) lactate \\>2mmol\u002FL 2-receiving either norepinephrine or phenylephrine with or without additional vasopressor support 3- total norepinephrine equivalent dose (NED) ≥0.1 mcg\u002Fkg\u002Fmin and ≤0.5 mcg\u002Fkg\u002Fmin, to maintain a MAP of at least 65 mmHg, is required for randomization 4-ability to consent and randomize within 24 hrs of first reaching NED threshold and within 48 hrs of hospital arrival\n\nExclusion Criteria:\n\n* Age \\\u003C18 years\n* Prisoners\n* Pregnant women\n* Patients for whom urgent surgery is anticipated\n* Leukocyte count \\\u003C1,000 cells\u002FμL\n* Absolute monocyte count \\\u003C200 cells\u002FμL\n* Bone marrow transplant within the past 30 days\n* Patients that will be withdrawing aggressive resuscitation, including withdraw of vasopressor support\n* transfer from outside ICU\n* history of liver cirrhosis with Child-Pugh score ≥6",{"count":187,"type":22},78,[189],"PHASE4","Despite best therapy efforts, sepsis and septic shock are associated with mortality rates of up to 40%. This clinical trial will determine the benefit of exogenous Angiotensin II versus norepinephrine (conventional care) treatment in septic shock patients. This trial will determine whether there are better predictors of septic shock severity. This approach may inform more appropriate treatment regimens and improve outcomes for these patients.",[29],[193,194,195],"sepsis","kidney disease","intensive care","2026-07-23",{"date":198,"type":36},"2026-07-24",{"date":149,"type":22},{"date":201,"type":22},"2028-10-07",{"name":203,"class":43},"Wake Forest University Health Sciences",2,{"id":206,"slug":207,"hasResults":12,"nctId":208,"briefTitle":209,"officialTitle":210,"acronym":211,"eligibilityCriteria":212,"healthyVolunteers":213,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":214,"targetDuration":4,"studyType":23,"phases":216,"briefSummary":217,"conditions":218,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":220,"startDateStruct":221,"completionDateStruct":223,"leadSponsor":225,"locationsCount":4},"100648434","alterations-of-the-renin-angiotensin-aldosterone-system-in-septic-shock-100648434","NCT07721974","Alterations of the Renin-angiotensin-aldosterone System in sEptic Shock","\" Étude Des altérations du système rénine-angiotensine-aldostérone au Cours du Choc Septique \" Alterations of the Renin-angiotensin-aldosterone System in sEptic Shock","ARES","Inclusion Criteria:\n\nAdult patients with septic shock:\n\n* Proven or suspected infection.\n* Persistent arterial hypotension requiring norepinephrine administration to maintain a mean arterial pressure above 65 mmHg despite adequate fluid resuscitation.\n* Hyperlactatemia \\> 2 mmol\u002FL.\n\nAdult critically ill control patients with sepsis without circulatory failure:\n\n* Proven or suspected infection.\n* Absence of persistent arterial hypotension requiring norepinephrine administration to maintain a mean arterial pressure above 65 mmHg.\n* An increase of at least 2 points in the SOFA score attributable to infection.\n\nAdult critically ill control patients with cardiogenic shock:\n\n* Acute cardiac disease, such as myocardial infarction.\n* Persistent arterial hypotension requiring norepinephrine administration to maintain a mean arterial pressure above 65 mmHg despite adequate fluid resuscitation.\n* Low cardiac output: cardiac index \\\u003C 2.2 L\u002Fmin\u002Fm² or the need for inotropic support (including norepinephrine) to maintain a cardiac index \\> 2.2 L\u002Fmin\u002Fm².\n* Elevated left ventricular filling pressures, measured invasively or estimated by echocardiography.\n* Hyperlactatemia \\> 2 mmol\u002FL.\n\nAdult healthy volunteers:\n\n* Absence of active or chronic disease.\n* Absence of long-term medication use.\n* No surgery or medication intake within the previous month.\n* Absence of ongoing pregnancy.\n* Non-smoker.\n\nExclusion Criteria:\n\n* Patients deprived of liberty by judicial or administrative decision.\n* Patients admitted to the intensive care unit for more than 48 hours.\n* Patients previously enrolled in an interventional study with overlapping follow-up.\n* Patients benefiting from State Medical Aid (AME).",true,{"count":215,"type":22},320,[25],"Septic shock is a common and life-threatening condition associated with an in-hospital mortality rate exceeding 40%. The symptomatic management of septic shock relies primarily on vasopressor therapy, particularly norepinephrine. However, the use of high doses of norepinephrine may lead to adverse effects, prompting the search for alternative therapeutic strategies, including angiotensin II, which has recently been investigated as an adjunctive vasopressor.\n\nIndeed, alterations of the renin-angiotensin-aldosterone system (RAAS), particularly a relative deficiency of angiotensin II, have been hypothesized to occur during septic shock. However, to date, no human study has used gold-standard techniques for measuring RAAS peptides to confirm this hypothesis.\n\nFurthermore, it remains unclear whether these alterations are specific to septic shock or may also be observed in less severe infections (sepsis) or in other forms of circulatory failure, such as cardiogenic shock.",[29],"2026-07-20",{"date":196,"type":36},{"date":222,"type":22},"2026-09-15",{"date":224,"type":22},"2031-10",{"name":153,"class":43},{"id":227,"slug":228,"hasResults":12,"nctId":229,"briefTitle":230,"officialTitle":230,"acronym":4,"eligibilityCriteria":231,"healthyVolunteers":12,"sex":18,"minAge":232,"maxAge":4,"enrollmentInfo":233,"targetDuration":4,"studyType":23,"phases":235,"briefSummary":237,"conditions":238,"keywords":241,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":250,"lastUpdatePostDateStruct":251,"startDateStruct":253,"completionDateStruct":255,"leadSponsor":257,"locationsCount":44},"100633704","phase-3-comparative-efficacy-and-safety-of-propofol-ketamine-combination-versus-propofol-monotherapy-in-geriatric-patients-under-invasive-ventilation-100633704","NCT07530146","Comparative Efficacy and Safety of Propofol-Ketamine Combination Versus Propofol Monotherapy in Geriatric Patients Under Invasive Ventilation","Inclusion Criteria:\n\n* Age ≥ 65 years\n* Admitted to ICU with a diagnosis of infection (sepsis, septic shock, or pneumonia)\n* Known history of cardiac disease (e.g., ischemic heart disease, heart failure, arrhythmias)\n* Requiring endotracheal intubation for airway protection or respiratory failure\n* Informed consent obtained from patient or legal representative\n* Patient NOT on sedation prior randomization.\n\nExclusion Criteria:\n\n* Known allergy or contraindication to propofol or ketamine\n* Severe hepatic or renal dysfunction (Child-Pugh C, eGFR \\\u003C 30 mL\u002Fmin\u002F1.73m²)\n* Uncontrolled hypertension (SBP \\> 180 mmHg or DBP \\> 110 mmHg)\n* Intracranial pathology (e.g., raised intracranial pressure, recent stroke, brain tumor)\n* Ongoing use of other sedative or anesthetic agents within 12 hours prior to intubation\n* Do-not-intubate or do-not-resuscitate orders\n* Participation in another interventional trial within the last 30 days\n* History of Psychosis\n* Severe Organ Dysfunction: Patients with Child-Pugh C hepatic failure\n* • Severe hypotension despite vasopressor therapy (systolic blood pressure \\\u003C 100 mmHg or diastolic blood pressure \\\u003C 70 mmHg)","65 Years",{"count":234,"type":22},41,[236],"PHASE3","The study is a prospective randomized controlled trial comparing the efficacy and safety of propofol-ketamine (\"Ketofol\") versus propofol monotherapy in geriatric ICU patients. Eligible participants are critically ill elderly patients with a history of cardiac disease who require endotracheal intubation and have not yet received sedation. The investigators focus on a specific population in which geriatric patients have different pharmacokinetics and pharmacodynamics and are more prone to side effects than other populations.\n\nPrimary outcome: Incidence of hemodynamic instability (defined as hypotension requiring vasopressors), measured by mean arterial pressure (MAP) at baseline, during intubation, and post-intubation at 1, 5, 10, 30, and then every 8h for 24 hours.",[239,29,240],"The Critically Ill Patient is Requiring Intubation","Pneumonia",[242,243,31,244,245,246,247,248,249],"ketofol","propofol","pneumonia","geriatric","elderly","critical ill","ICU patient","intubation","2026-07-19",{"date":252,"type":36},"2026-07-21",{"date":254,"type":36},"2026-05-13",{"date":256,"type":22},"2026-10",{"name":258,"class":43},"Helwan University",{"id":260,"slug":261,"hasResults":12,"nctId":262,"briefTitle":263,"officialTitle":264,"acronym":4,"eligibilityCriteria":265,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":266,"targetDuration":4,"studyType":23,"phases":268,"briefSummary":269,"conditions":270,"keywords":271,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":277,"lastUpdatePostDateStruct":278,"startDateStruct":279,"completionDateStruct":281,"leadSponsor":283,"locationsCount":44},"100648012","effect-of-targeting-upper-normal-serum-magnesium-levels-on-norepinephrine-requirements-in-septic-shock-patients-100648012","NCT07716956","Effect of Targeting Upper Normal Serum Magnesium Levels on Norepinephrine Requirements in Septic Shock Patients","Effect of Targeting Upper Normal Serum Magnesium Levels on Norepinephrine Requirements in Septic Shock Patients: a Randomized Controlled Trial.","Inclusion Criteria:\n\n* Male and female adult patients (aged ≥18 years) diagnosed with septic shock.\n* Resistant septic shock that requires corticosteroids.\n\nExclusion Criteria:\n\n* Pregnancy.\n* Baseline hypermagnesemia (serum magnesium level \\> 2.3 mg\u002FdL).\n* Renal impairment with creatinine clearance (CrCl) \\\u003C 10 ml\u002Fmin.\n* Mixed shock.",{"count":267,"type":22},60,[25],"The goal of this clinical trial is to assess the effect of targeting upper normal serum magnesium levels on norepinephrine requirements in adult patients with septic shock.\n\nThe main questions it aims to answer are:\n\n1. Does maintaining upper normal serum magnesium levels lower the total cumulative dose and duration of norepinephrine therapy?\n2. Does this approach reduce the intensive care unit (ICU) length of stay, duration of mechanical ventilation and mortality?\n\nThis study will compare an intervention group to a control group to see the effect of targeting upper normal serum magnesium levels.\n\nParticipants will:\n\n* Have their serum magnesium levels assessed at baseline (Day 0), at three-day intervals (Days 3, 6, 9) thereafter and on the day of norepinephrine discontinuation.\n* Receive individualized intravenous magnesium sulfate infusions to achieve and maintain the target serum magnesium levels.\n* Have their demographic data collected and be monitored closely for clinical data, vital signs, Mean Arterial Pressure (MAP), urine output and laboratory parameters.",[29,28],[272,273,274,275,276],"vasopressors","norepinephrine","magnesium sulfate","magnesium level","ICU ( Intensive Care Unit )","2026-07-16",{"date":252,"type":36},{"date":280,"type":22},"2026-07",{"date":282,"type":22},"2027-07",{"name":284,"class":43},"Alexandria University",{"id":286,"slug":287,"hasResults":12,"nctId":288,"briefTitle":289,"officialTitle":290,"acronym":291,"eligibilityCriteria":292,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":293,"targetDuration":4,"studyType":80,"phases":4,"briefSummary":295,"conditions":296,"keywords":297,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":277,"lastUpdatePostDateStruct":301,"startDateStruct":303,"completionDateStruct":305,"leadSponsor":307,"locationsCount":4},"100645454","comparison-of-manual-paop-and-automatic-paop-smart-wedge-100645454","NCT07703592","Comparison of Manual PAOP and Automatic PAOP (Smart Wedge)","Comparison of Pulmonary Artery Occlusion Pressure (PAOP) Measurements Performed by an Expert Versus Those Obtained Using the SmartWedge Algorithm in Patients Undergoing Pulmonary Artery Catheterization (Swan-Ganz IQ™).","SMART-PAPO","Inclusion Criteria:\n\n* Age ≥18 years;\n* Admission to an intensive care unit;\n* Presence of a Swan-Ganz IQ™ pulmonary artery catheter placed as part of patient care;\n* Measurement of pulmonary artery occlusion pressure (PAOP) performed by the attending clinician as part of patient care.\n\nExclusion Criteria:\n\n* Pregnancy;\n* Court-ordered protective measures.\n* Refusal to participate by the patient's family members or the patient themselves.\n* Cardiac output measurements by thermodilution or by continuous cardiac output analysis that cannot be interpreted.",{"count":294,"type":22},30,"The pulmonary artery catheter (Swan-Ganz) is a standard tool in intensive care for measuring and monitoring the pulmonary artery occlusion pressure (PAOP). The Swan-Ganz IQ™ model also allows automatic measurement to reduce the risk of error (Smart Wedge). However, the concordance between this automatic method and the manual method remains poorly studied in real clinical conditions and may vary depending on certain clinical situations. This study therefore aims to compare the PAOP automatically measured (Smart Wedge) with the manual PAOP measurement at bedside based on data collected in clinical practice.",[29],[298,299,300],"Swan-ganz IQ™","Swan-Ganz","pulmonary artery occlusion preassure",{"date":302,"type":36},"2026-07-17",{"date":304,"type":22},"2026-07-10",{"date":306,"type":22},"2028-07-10",{"name":153,"class":43},{"id":309,"slug":310,"hasResults":12,"nctId":311,"briefTitle":312,"officialTitle":313,"acronym":314,"eligibilityCriteria":315,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":316,"targetDuration":4,"studyType":23,"phases":318,"briefSummary":319,"conditions":320,"keywords":321,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":326,"lastUpdatePostDateStruct":327,"startDateStruct":328,"completionDateStruct":330,"leadSponsor":332,"locationsCount":44},"100450653","phase-4-albumin-and-crystalloid-administration-in-septic-shock-100450653","NCT05148286","Albumin and Crystalloid Administration in Septic Shock","Albumin and Crystalloid Administration in Septic Shock (ALCAMIST): Multi-center, Open Labelled Randomized Controlled Trial","ALCAMIST","Inclusion Criteria:\n\n* Adult patients (≥ 18 years) who visit an ED directly and are suspected of sepsis with shock\n* Shock is defined as hypotension (mean arterial blood pressure (MAP) \\\u003C 65 or systolic blood pressure \\\u003C 80) and tissue hypoperfusion such as an initial serum lactate level ≥ 4 mmol\u002FdL.\n\nExclusion Criteria:\n\n* patients who are transferred from another hospital after initial fluid administration\n* patients who have set limitations on treatment (e.g. patients with a signed do-not-resuscitate order)\n* patients with moribund conditions with life expectancy less than 28 days due to secondary diseases or advanced malignant disease and palliative situations with life expectancy less than 6 months\n* patients who have been administered albumin before enrollment\n* patients who have known hypersensitivity to albumin\n* Clinical conditions, where albumin administration may be unfavorable (e.g. pulmonary edema, congestive heart failure, traumatic brain injury)\n* lactation\n* patients who do not voluntarily consent to participate in the trial.",{"count":317,"type":22},2426,[189],"The current guideline emphasizes fluid resuscitation as the mainstay of initial management for septic shock. Albumin has the oncotic activity to maintain intravascular volumes with additional beneficial properties in sepsis. Prior studies showed that the replacement of albumin might have survival advantages in patients with septic shock. The investigators aim to assess whether the early administration of albumin with crystalloid as initial fluid resuscitation improves survival in patients with septic shock compared to resuscitation without albumin.",[29],[322,323,324,325],"Septic shock","Fluid resuscitation","Albumin","Crystalloid","2026-07-15",{"date":277,"type":36},{"date":329,"type":36},"2022-01-17",{"date":331,"type":22},"2027-12-31",{"name":333,"class":43},"Asan Medical Center",{"id":335,"slug":336,"hasResults":12,"nctId":337,"briefTitle":338,"officialTitle":339,"acronym":340,"eligibilityCriteria":341,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":133,"enrollmentInfo":342,"targetDuration":4,"studyType":23,"phases":344,"briefSummary":345,"conditions":346,"keywords":347,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":353,"lastUpdatePostDateStruct":354,"startDateStruct":355,"completionDateStruct":357,"leadSponsor":359,"locationsCount":44},"100647605","effects-of-hemoadsorption-on-vascular-integrity-in-septic-shock-100647605","NCT07711197","Effects of Hemoadsorption on Vascular Integrity in Septic Shock","Effects of Hemoadsorption on Vascular Integrity in Septic Shock (ADSORP-VIP Trial): Protocol of a Prospective, Randomised, Controlled Trial","ADSORP-VIP","Inclusion Criteria:\n\n* Septic shock as defined by Sepsis-3 criteria.\n* Serum lactate levels \\>2 and \\\u003C8 mmol\u002FL at screening.\n* Fluid unresponsiveness: Objectively confirmed via dynamic tests or fluid challenges following initial resuscitation.\n* Vasopressor Dose Threshold: Norepinephrine base equivalent (NEE) dose \\> 0.5 µg\u002Fkg\u002Fmin.\n* Systemic corticosteroid treatment on board for at least 30 minutes.\n* Tissue perfusion impairment: Persistently elevated serum lactate AND\u002FOR prolonged capillary refill time (\\> 3 seconds) despite standard therapy.\n* Alternative causes of shock (e.g., obstructive or cardiogenic) must be ruled out using critical care ultrasonography (CCUS).\n* Arterial, central venous catheters and an invasive hemodynamic device (PiCCO, Getinge) in place.\n* Inclusion within a maximum of 12 hours after the onset of vasopressor need.\n* High likelihood of a dysregulated immune response (PCT ≥ 5 ng\u002FmL AND\u002FOR IL-6 ≥ 1000 pg\u002FmL AND\u002FOR Ferritin ≥ 1000 ng\u002FmL).\n* Written informed, retrospective or prospective consent.\n\nExclusion Criteria:\n\n* Patients under 18 years of age and over 80.\n* Unlikely to survive for 24 hours (Moribund).\n* Pregnancy.\n* SOFA-2 score ≥ 16 at ICU admission.\n* Source control is uncertain.\n* Thrombocytopenia (\\\u003C20,000\u002FµL).\n* Criteria of standard guideline-based medical treatment not exhausted.\n* End-stage organ failure (chronic renal failure (estimated glomerular filtration rate (eGFR) \\\u003C15 mL\u002Fmin\u002F1.73 m2), chronic liver failure (MELD Score \\>30, ChildPugh score class C.), chronic heart failure (New York Heart Association class IV.); severe chronic pulmonary disease (chronic obstructive pulmonary disease: GOLD D)).\n* Expected need to disconnect CytoSorb therapy for more than 2 hours (e.g., surgery, CT transfer).",{"count":343,"type":22},110,[25],"This study aims to investigate the effects of adjunctive CytoSorb hemoadsorption therapy versus standard medical treatment on endothelial dysfunction in patients with refractory septic shock. The investigators hypothesize that hemoadsorption mitigates endothelial and glycocalyx injury by removing inflammatory mediators and other injurious circulating molecules, promoting hemodynamic stabilization.",[29],[193,31,348,349,350,351,352],"hemoadsorption","CytoSorb","endothelial dysfunction","syndecan-1","vasoplegia","2026-07-14",{"date":302,"type":36},{"date":356,"type":22},"2026-09-01",{"date":358,"type":22},"2029-01-01",{"name":360,"class":43},"Semmelweis University",{"id":362,"slug":363,"hasResults":12,"nctId":364,"briefTitle":365,"officialTitle":366,"acronym":367,"eligibilityCriteria":368,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":369,"targetDuration":371,"studyType":80,"phases":4,"briefSummary":372,"conditions":373,"keywords":375,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":353,"lastUpdatePostDateStruct":376,"startDateStruct":377,"completionDateStruct":379,"leadSponsor":381,"locationsCount":204},"100622823","artice-real-data-collection--observational-trial-phase-4-study-100622823","NCT07388628","ARTICE® Real Data Collection & Observational Trial, Phase 4 Study","ARTISTRY - ARTICE® Therapy Registry Study","ARTistry","Inclusion Criteria:\n\n* Subjects ≥ 18 years who are planned to receive ARTICE® treatment during their ICU stay\n\nExclusion Criteria:\n\n\\-",{"count":370,"type":22},200,"7 Days","The objectives of this registry study are to:\n\n1. Record real-life data related to the use of the ARTICE® therapy in sepsis subjects.\n2. Further evaluate ARTICE® treatment efficacy.\n3. Identify potential sub-groups, assess their risk-benefit- and safety profile.\n4. Changes in SOFA score D0 to SOFA Score D7.",[28,29,374],"Immunoparalysis in Septic Shock",[28,31,374],{"date":326,"type":36},{"date":378,"type":36},"2025-09-25",{"date":380,"type":22},"2027-12",{"name":382,"class":383},"Artcline GmbH","INDUSTRY",{"id":385,"slug":386,"hasResults":12,"nctId":387,"briefTitle":388,"officialTitle":389,"acronym":390,"eligibilityCriteria":391,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":392,"targetDuration":4,"studyType":80,"phases":4,"briefSummary":394,"conditions":395,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":304,"lastUpdatePostDateStruct":396,"startDateStruct":398,"completionDateStruct":400,"leadSponsor":402,"locationsCount":44},"100367698","septic-shock-induced-immunosuppression-100367698","NCT04067674","Septic Shock-induced Immunosuppression","Evaluation of Immunosuppression in Septic Shock: Biomarkers and Pharmacological Restoration","IMMUNOSEPSIS 4","Inclusion Criteria:\n\n* Age over 18 years\n* Patient admitted to ICU\n* Diagnosis of septic shock within less than 48h at time of screening defined by :\n* Presence of a microbiologically diagnosed or suspected infection\n* Initiation of a vasopressive treatment to maintain mean arterial blood pressure ≥ 65 mm Hg initiated during the first 48h after ICU admission\n* Presence of an hyperlactatemia \\> 2 mmol\u002FL (18 mg\u002FdL) during the 24h before or after initiation of vasopressive treatment despite adequate volemic reanimation (30 ml\u002Fkg)\n* Blood sample at D3\u002FD4 available (lab working days)\n* Non opposition to study participation obtained from patient or next of kin\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding woman\n* Patient with no social security insurance, with restricted liberty or under legal protection\n* Language barrier\n* Patient taking part in interventional study about medicin that could interfere with biologic results",{"count":393,"type":22},305,"Septic syndromes are a major although largely under-recognized health care problem and represent the first cause of mortality in intensive care units (ICU). While it has long been known that sepsis deeply perturbs immune homeostasis by inducing a tremendous systemic inflammatory response, novel findings indicate that sepsis indeed initiates a more complex immune response that varies over time, with the concomitant occurrence of both pro- and anti-inflammatory mechanisms. As a resultant, after a short pro-inflammatory phase, septic patients enter a stage of protracted immunosuppression. This is illustrated in those patients by reactivation of dormant viruses (cytomegalovirus (CMV) or Herpes Simplex Virus (HSV)) or infections due to pathogens, including fungi, which are normally pathogenic solely in immunocompromised hosts. These alterations might be directly responsible for worsening outcome in patients who survived initial resuscitation as nearly all immune functions are deeply compromised. New promising therapeutic strategies are currently emerging from those recent findings such as adjunctive immunostimulation for the most immunosuppressed patients. The prerequisite for immunostimulation administration (Interferon gama (IFNg), Granulocyte Macrophage Colony Stimulating Factor (GM-CSF), interleukin 7 (IL-7)) however relies on clinicians' capacity to identify patients who could benefit the most from these immunoadjuvant therapies, as there is no clinical sign of immune dysfunctions.\n\nIn this context, the main objectives of IMMUNOSEPSIS 4 study are:\n\n1. to identify the best biomarkers for sepsis-induced immunosuppression\n2. to evaluate ex vivo candidate treatments which could rejuvenate immune functions after septic shock",[29],{"date":397,"type":36},"2026-07-13",{"date":399,"type":36},"2019-10-21",{"date":401,"type":22},"2026-11-21",{"name":403,"class":43},"Hospices Civils de Lyon",{"id":405,"slug":406,"hasResults":12,"nctId":407,"briefTitle":408,"officialTitle":408,"acronym":409,"eligibilityCriteria":410,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":411,"targetDuration":4,"studyType":23,"phases":413,"briefSummary":414,"conditions":415,"keywords":416,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":418,"lastUpdatePostDateStruct":419,"startDateStruct":420,"completionDateStruct":422,"leadSponsor":424,"locationsCount":426},"100630133","association-between-muscle-l3-ct-scan-muscle-derived-parameters-of-muscle-function-upon-intensive-care-unit-admission-and-3-months-mortality-after-icu-discharge-for-patients-admitted-for-septic-shock-the-sims-study-100630133","NCT07483710","Association Between Muscle L3 CT Scan Muscle Derived Parameters of Muscle Function Upon Intensive Care Unit Admission and 3 Months Mortality After ICU Discharge for Patients Admitted for Septic Shock. The SIMS Study","SIMS","Inclusion Criteria:\n\nPatients hospitalized in intensive care for septic shock defined by the presence of a documented or suspected infection, plasma lactate \\>2 mmol\u002FL, and an increase in SOFA score of more than 2 points from baseline (Singer et al., 2016)\n\n* Patients who underwent a non-contrast CT scan within 48 hours prior to admission and up to 24 hours after admission to intensive care\n* Patients affiliated with or eligible for social security\n\nExclusion Criteria:\n\n* Patients with a neuromuscular disease prior to admission to intensive care.\n* Pregnant women\n* Patients under guardianship and\u002For conservatorship\n* Refusal of consent.",{"count":412,"type":22},196,[25],"Muscle dysfunction in intensive care units is associated with significant morbidity and mortality. During septic shock, there is an increased catabolism and systemic inflammation resulting in quantitative and qualitative muscle impairment. In the intensive care setting, quantitative and qualitative assessment of muscle function is challenging due to critical care environments (general anesthesia, altered consciousness, etc.). CT scan measurement at the 3rd lumbar level has been proposed to evaluate muscle function. Recent retrospective studies have highlighted increased mortality among patients with muscle mass impairment and\u002For decreased muscle density.",[29],[31,417],"CT Scan","2026-07-08",{"date":304,"type":36},{"date":421,"type":36},"2026-03-19",{"date":423,"type":22},"2030-05-01",{"name":425,"class":43},"Centre Hospitalier Universitaire de Saint Etienne",4,{"id":428,"slug":429,"hasResults":12,"nctId":430,"briefTitle":431,"officialTitle":432,"acronym":4,"eligibilityCriteria":433,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":434,"targetDuration":4,"studyType":80,"phases":4,"briefSummary":436,"conditions":437,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":438,"lastUpdatePostDateStruct":439,"startDateStruct":440,"completionDateStruct":441,"leadSponsor":443,"locationsCount":4},"100646012","splanchnic-perfusion-monitoring-in-septic-shock-using-doppler-ultrasound-100646012","NCT07698834","Splanchnic Perfusion Monitoring in Septic Shock Using Doppler Ultrasound","Splanchnic Perfusion Monitoring Using Doppler Ultrasound in Septic Shock Patients: Correlation With Lactate Clearance, Organ Dysfunction, and Enteral Feeding Intolerance","Inclusion Criteria:\n\n* 1\\. Adult patients (≥18 years). 2. ICU admission with septic shock (Sepsis-3 definitions).\n\nExclusion Criteria:\n\n\\- 1. Advanced chronic liver disease. 2. Portal vein thrombosis. 3. Mesenteric ischemia (or clinical suspicion strongly suggesting it). 4. Severe right-sided heart failure. 5. Pregnancy. 6. Morbid obesity or any condition causing poor\u002Funsafe ultrasound acoustic window.\n\n7\\. Intra-abdominal conditions preventing adequate Doppler assessment. 8. Limitation of care \u002F do-not-resuscitate orders. 9. Pre-existing major gastrointestinal bleeding\u002Fobstruction if that is relevant to enteral feeding intolerance outcomes in your ICU.",{"count":435,"type":22},80,"evaluation whether splanchnic Doppler ultrasound indices (SMA resistive index, portal vein pulsatility fraction, hepatic artery resistive index\u002Fflow parameters) can:\n\n1. Reflect regional tissue perfusion in septic shock, as correlated with lactate clearance.\n2. Associate with organ dysfunction severity and progression (SOFA dynamics).\n3. Predict enteral feeding intolerance in ICU patients receiving enteral nutrition",[29],"2026-07-07",{"date":397,"type":36},{"date":149,"type":22},{"date":442,"type":22},"2027-10",{"name":444,"class":43},"Assiut University",{"id":446,"slug":447,"hasResults":12,"nctId":448,"briefTitle":449,"officialTitle":450,"acronym":451,"eligibilityCriteria":452,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":133,"enrollmentInfo":453,"targetDuration":4,"studyType":23,"phases":455,"briefSummary":456,"conditions":457,"keywords":458,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":462,"lastUpdatePostDateStruct":463,"startDateStruct":465,"completionDateStruct":467,"leadSponsor":469,"locationsCount":471},"100641441","hemoadsorpion-in-patients-with-septic-shock-efficacy-and-safety-evaluation-100641441","NCT07661303","Hemoadsorpion in Patients With Septic Shock: Efficacy and Safety Evaluation","Hemoadsorpion in Patients With Septic Shock: Efficacy and Safety Evaluation. A Pilot Multicenter Randomized Controlled Trial","HAdSS","Inclusion Criteria:\n\n* Septic shock according to SEPSIS-3 criteria\n* Age: 18-80 years\n* SOFA ≥9 points\n* Diagnosis of septic shock established \\\u003C12 hours ago\n* Invasive hemodynamic monitoring\n* Norepinephrine dose \\>0.2 mcg\u002Fkg\u002Fmin\n\nExclusion Criteria:\n\n* Absolute neutrophil count less than 500 cells\u002FμL\n* Pregnancy\n* End-stage heart failure (NYHA stage IV)\n* Pulmonary embolism with obstructive shock\n* Ongoing bleeding\n* Atonic coma\n* More than 30 points on the MELD scale, class C on the Child-Pugh scale\n* HIV infection\n* Burns over 10% of the body surface area\n* Patients with oncohematological diseases\n* Patients with a recognized palliative status or the definition of \"metastatic cancer\"\n* RRT using membranes with a high cutoff point and increased adsorption capacity within 72 hours from the initiation of the first hemoadsorption procedure\n* Use of plasma exchange within 72 hours from the initiation of the first hemoadsorption procedure",{"count":454,"type":22},76,[25],"Hemoadsorpion in Patients With Septic Shock: Efficacy and Safety Evaluation. A Pilot Multicenter Randomized Controlled Trial.\n\nThe goal of this clinical trial is the estimation of the efficacy and safety of hemoadsorption procedures (LPS (Lipopolysaccharide) and inflammatory mediators adsorption) in participants with septic shock.\n\nThe main questions it aims to answer are:\n\nDoes hemoadsorption decrease the severity of MODS (multiple organ disfunction syndrome)?\n\nThe study will include participants aged 18 to 80 years with a verified diagnosis of septic shock according to SEPSIS 3 criteria, diagnosed within 12 hours, and a SOFA (sequential organ failure assessment) score of 9 or more.\n\nIn addition to Standard of Care (SOC), blood purification, including hemoadsorption, will be used. The minimum waiting time after diagnosis of septic shock and initiation of basic therapy before inclusion of the patient in the study therapy is 4 hours.\n\nThe choice of procedure will be based on the EAA (Endotoxin Activity Assay) result:\n\n* for an EAA level of 0.6-0.9, selective lipopolysaccharide (LPS) adsorption with duration from 2 to 10 hours;\n* for an EAA level less than 0.6, inflammatory mediator adsorption with duration from 6 to 12 hours.\n\nThe choice of a specific adsorbers within the LPS and inflammatory mediator adsorption group will be based on randomization.\n\nThe use of LPS adsorption is planned based on randomization: Toramyxin R-20 or Efferon LPS. The use of inflammatory mediator adsorption is planned based on randomization: Jafron (HA 330) or CytoSorb.",[29],[322,348,459,460,461],"blood purification","MODS","Endotoxemia","2026-06-30",{"date":464,"type":36},"2026-07-02",{"date":466,"type":22},"2026-06-25",{"date":468,"type":22},"2027-12-25",{"name":470,"class":125},"Moscow Multidisciplinary Clinical Center \"Kommunarka\"",7,{"id":473,"slug":474,"hasResults":12,"nctId":475,"briefTitle":476,"officialTitle":476,"acronym":477,"eligibilityCriteria":478,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":479,"targetDuration":4,"studyType":80,"phases":4,"briefSummary":481,"conditions":482,"keywords":483,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":488,"lastUpdatePostDateStruct":489,"startDateStruct":491,"completionDateStruct":493,"leadSponsor":495,"locationsCount":44},"100646844","characterizing-perfusion-and-congestion-responses-to-fluid-loading-in-critically-ill-septic-patients-100646844","NCT07685002","Characterizing Perfusion and Congestion Responses to Fluid Loading in Critically Ill Septic Patients","FLUID-IMPACTS","Inclusion Criteria:\n\n* Patients with septic shock, defined according to proven or suspected infection with hypotension requiring vasopressor therapy, either community or hospital onset.\n* Mechanical ventilation\n* Central venous catheter in the superior vena cava territory\n* Arterial catheter in place\n* Positive passive leg-raising (PLR) test-defined as an increase of \\>10% in subaortic velocity-time integral-which predicts responsiveness to fluid loading.\n\nExclusion Criteria:\n\n* Contraindication to performing a passive leg-raising manoeuvre (e.g., unstable spinal fracture, intracranial hypertension, critical limb ischemia).\n* Age \\\u003C 18 years.\n* Lack of social coverage or individuals deprived of liberty.\n* Pregnant women.\n* Extracorporeal membrane oxygenation (veno-venous or venoarterial)\n* Cirrhosis with portal hypertension or portal vein thrombosis\n* Inability to obtain non-opposition from the patient or their legal representative.",{"count":480,"type":22},170,"Sepsis is a leading cause of mortality worldwide and a major contributor to deaths in intensive care units. Early hemodynamic resuscitation, particularly fluid loading, is a cornerstone of septic shock management. However, the benefit-risk balance of fluid administration is difficult to assess in routine practice. Insufficient fluid resuscitation may result in persistent tissue hypoperfusion, organ ischemia, and multiorgan failure, whereas excessive fluid administration is associated with increased mortality, mainly due to systemic venous congestion and organ edema.\n\nThe concept of fluid tolerance, defined as the ability of a patient to receive fluids without developing harmful consequences related to fluid overload, is increasingly recognized. Nevertheless, its evaluation remains challenging because of the lack of validated tools and consensual thresholds. In addition, although several markers of tissue perfusion and systemic venous congestion have been described, their combined clinical relevance and prognostic value following fluid loading in septic shock have not been specifically evaluated.\n\nThis study aims to assess perfusion and congestion responses to fluid loading in patients with septic shock. The primary objective is to compare patients according to changes in tissue perfusion markers (lactate concentration, mottling score, capillary refill time, venous-to-arterial CO₂ gradient, and central venous oxygen saturation) and systemic venous congestion markers (central venous pressure and hepatic and portal vein Doppler indices) after fluid administration. Secondary objectives include evaluating the evolution of venous congestion markers and their association with organ dysfunction within 48 hours, the relationship between post-fluid loading congestion dynamics and 28-day mortality, and identifying pre-fluid loading predictors of patients who fail to improve tissue perfusion while exhibiting worsening venous congestion.\n\nThis is a prospective, multicenter, non-interventional observational cohort study conducted in five intensive care units. Eligible patients are adult patients with septic shock, mechanically ventilated, equipped with arterial and central venous catheters, and presenting a positive passive leg-raising test defined as an increase greater than 10% in cardiac output or left ventricular outflow tract velocity-time integral. All patients receive standard care in accordance with international guidelines, and fluid administration is entirely at the discretion of the treating physician.\n\nClinical, biological, hemodynamic, and echocardiographic data are collected before and after fluid loading. Patients are retrospectively classified into four groups based on the presence or absence of improvement in tissue perfusion and worsening of venous congestion. Follow-up continues until ICU discharge or day 28.\n\nApproximately 280 patients are expected to be screened to include 170 patients. The results may help identify patients who are fluid responsive in terms of cardiac output but at risk of harmful venous congestion, supporting more individualized fluid resuscitation strategies in septic shock.",[29],[193,484,485,486,487],"septic","shock","fluid load","organ dysfunction","2026-06-29",{"date":490,"type":36},"2026-07-06",{"date":492,"type":22},"2026-06",{"date":494,"type":22},"2028-06",{"name":153,"class":43},{"id":497,"slug":498,"hasResults":12,"nctId":499,"briefTitle":500,"officialTitle":501,"acronym":502,"eligibilityCriteria":503,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":504,"targetDuration":4,"studyType":80,"phases":4,"briefSummary":505,"conditions":506,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":508,"lastUpdatePostDateStruct":509,"startDateStruct":510,"completionDateStruct":512,"leadSponsor":513,"locationsCount":44},"100646948","biomarkers-of-inflammation-infection-and-immunity-in-the-critical-area-marina-the-use-of-inflammatory-and-immunity-biomarkers-as-early-predictors-of-clinical-severity-organ-damage-response-to-treatment-and-infectious-complications-in-patients-admitted-to-the-critical-care-area-100646948","NCT07682766","BioMArkeRs of INflammation, Infection, and Immunity in the Critical Area (MARINA): the Use of Inflammatory and Immunity Biomarkers as Early Predictors of Clinical Severity, Organ Damage, Response to Treatment, and Infectious Complications in Patients Admitted to the Critical Care Area.","The MARINA Study: bioMArkeRs of INflammation, Infection, and Immunity in the Critical Area: the Use of Inflammatory and Immunity Biomarkers as Early Predictors of Clinical Severity, Organ Damage, Response to Treatment, and Infectious Complications in Patients Admitted to the Critical Care Area.","MARINA","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Written informed consent to participate in the study (or deferred consent, obtained as soon as clinically feasible, in patients unable to provide consent at the time of enrollment)\n* Surgical group: patients who have undergone a high-risk elective or emergency surgical procedure under general anesthesia within the previous 24 hours (cardiac surgery, thoracic surgery, abdominal surgery)\n* Infection group: suspected or confirmed infection (including sepsis and septic shock), either community- or hospital-acquired\n* Immunocompromised group (subset of the infection group): patients with impaired immune status, including solid organ transplant (SOT) recipients, hematopoietic stem cell transplant (HSCT) recipients, bone marrow transplant recipients, CAR-T cell therapy recipients, or any other form of severe immunosuppression\n\nExclusion Criteria:\n\n* Refusal to provide informed consent\n* Age \\\u003C 18 years\n* Pregnancy\n* Therapeutic limitations or clinical decision to withdraw or withhold life-sustaining treatment at the time of enrollment",{"count":370,"type":22},"The MARINA study (bioMARkers of INflammation, infection, and immunity in critical cAre) is a multicenter, prospective and retrospective observational cohort study designed to evaluate the diagnostic and prognostic role of inflammatory and immune biomarkers in critically ill patients.\n\nThe study enrolls adult patients (≥18 years) admitted to intensive care or step-down units who present with signs or symptoms of active infection, including sepsis and septic shock. Three main patient populations are targeted: (1) patients with suspected or confirmed infection (community- or hospital-acquired); (2) patients undergoing high-risk major surgery (cardiac, thoracic, or abdominal) under general anesthesia; and (3) immunocompromised patients (solid organ transplant, HSCT, bone marrow transplant, CAR-T cell therapy, or other severe immunosuppression).\n\nSerial measurements of established and emerging biomarkers - including procalcitonin, C-reactive protein, MR-proadrenomedullina, copeptin, ferritin, interleukin-6, troponin, D-dimer, lactate, lymphocyte subpopulations, and immunoglobulins - are collected at predefined time points (T1: within 24 hours; T2: within 72 hours; T7: at day 7 of ICU admission) and integrated with clinical data on a dedicated electronic platform.\n\nThe primary endpoint is 28-day mortality. Secondary endpoints include assessment of organ damage, clinical severity, response to treatment, infectious complications (including VAP and bacteremia), superinfections (bacterial, viral, fungal), ICU and hospital length of stay, and the ability of biomarkers to guide antimicrobial de-escalation. Long-term survival at 90 and 180 days is also assessed.\n\nA minimum sample size of 200 patients (prospective phase) is planned across participating centers in Italy and Spain. The study duration is four years from ethical approval.",[29,507],"Immunocompromised Patients","2026-06-26",{"date":490,"type":36},{"date":511,"type":36},"2025-01-01",{"date":331,"type":22},{"name":514,"class":43},"University of Turin, Italy",{"id":516,"slug":517,"hasResults":12,"nctId":518,"briefTitle":519,"officialTitle":520,"acronym":4,"eligibilityCriteria":521,"healthyVolunteers":213,"sex":18,"minAge":19,"maxAge":133,"enrollmentInfo":522,"targetDuration":524,"studyType":80,"phases":4,"briefSummary":525,"conditions":526,"keywords":527,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":531,"lastUpdatePostDateStruct":532,"startDateStruct":534,"completionDateStruct":535,"leadSponsor":537,"locationsCount":4},"100644180","myeloid-bias-in-the-bone-marrow-of-septic-patients-and-its-correlation-with-disease-severity-and-prognosis-a-single-center-prospective-cohort-study-100644180","NCT07667153","Myeloid Bias in the Bone Marrow of Septic Patients and Its Correlation With Disease Severity and Prognosis: A Single-Center, Prospective Cohort Study","Myeloid Bias in the Bone Marrow of Septic Patients","1\\. Inclusion Criteria\n\n(1) Sepsis-Associated Critical Illness Cohort\n\n* Age 18-80 years, both genders;\n* Meets the Sepsis-3.0 criteria: confirmed or suspected infection with an acute increase in SOFA score of ≥2 points;\n* Admitted to the intensive care unit (ICU) for 48-72 hours at the time of enrolment;\n* Expected ICU length of stay ≥7 days;\n* Written informed consent provided by the patient or their legally authorized representative.\n\n  (2) Non-Septic Critical Illness Cohort\n* Age 18-80 years, both genders;\n* Admitted to the ICU for 48-72 hours with a diagnosis of non-infectious critical illness, including but not limited to: (a) severe acute pancreatitis; (b) major trauma (Injury Severity Score ≥16); (c) post-major surgery (e.g., cardiovascular surgery, hepatectomy); (d) acute cerebrovascular disease (ischaemic stroke, intracerebral haemorrhage); (e) other critical conditions requiring ICU support;\n* Expected ICU length of stay ≥7 days;\n* Written informed consent provided by the patient or their legally authorized representative.\n\n  (3) Healthy Volunteer Control Cohort\n* Age 18-80 years, both genders.\n* No acute or chronic medical history; recent health check-up results are normal.\n* Normal complete blood count: white blood cell count, haemoglobin, and platelet count within the normal reference ranges;\n* Willing and able to provide written informed consent.\n\n  2\\. Exclusion Criteria\n\n  (1) Sepsis-Associated Critical Illness Cohort\n* Haematological disorders: previous or current primary haematological diseases affecting bone marrow haematopoiesis, including leukaemia, myelodysplastic syndromes, aplastic anaemia, multiple myeloma, lymphoma, etc;\n* Active malignancy or receipt of chemotherapy\u002Fradiotherapy within the past 3 years;\n* Immunosuppressed state: (a) use of immunosuppressive agents within the past 3 months (including glucocorticoids ≥0.5 mg\u002Fkg\u002Fday for ≥2 weeks); (b) history of solid organ or haematopoietic stem cell transplantation; (c) HIV infection or AIDS; (d) congenital immunodeficiency;\n* Blood transfusion or bone marrow transplantation within the past 3 months;\n* Severe chronic organ dysfunction: (a) Child-Pugh Class C liver disease; (b) end-stage renal disease (eGFR \\\u003C30 mL\u002Fmin) without regular dialysis;\n* Abnormalities at the puncture site: infection, rash, trauma, or anatomical deformity at the posterior superior iliac spine;\n* Pregnancy or breastfeeding;\n* Moribund state with expected survival \\\u003C24 hours;\n* Participation in another interventional clinical trial within 3 months before or at enrolment;\n* Refusal to sign informed consent by the patient or legal representative.\n\n  (2) Non-Septic Critical Illness Cohort\n* Evidence of infection: confirmed or suspected active infection (including pneumonia, intra-abdominal infection, urinary tract infection, bloodstream infection, etc.) within 48 hours of ICU admission;\n* All other exclusion criteria listed for the Sepsis-Associated Critical Illness Cohort (items 1-10) apply.\n\n  (3) Healthy Volunteer Control Cohort\n* History of infection within the past 1 month;\n* Abnormalities at the puncture site: infection, rash, trauma, or anatomical deformity at the posterior superior iliac spine;\n* Pregnancy or breastfeeding.",{"count":523,"type":22},45,"90 Days","Sepsis remains a leading cause of critical illness worldwide, yet the underlying mechanisms driving its profound and persistent immune dysfunction are incompletely understood. The bone marrow, as the birthplace of all immune cells, plays a central role in orchestrating systemic immune responses. Emerging evidence from animal models suggests that sepsis triggers emergency myeloid-biased hematopoiesis in the bone marrow, characterized by expansion of myeloid progenitors and myeloid-derived suppressor cells (MDSCs) at the expense of lymphoid and erythroid lineages. This bone marrow remodeling precedes peripheral immune alterations and may represent the initiating event of sepsis-induced immunosuppression. However, direct clinical evidence in humans is scarce. This prospective, single-center cohort study aims to systematically characterize bone marrow hematopoietic remodeling in patients with septic shock, compared to critically ill non-septic patients and healthy volunteers, and to determine whether the degree of myeloid lineage bias correlates with disease severity, immunosuppression, and adverse clinical outcomes.\n\nThis study will enroll three cohorts. Bone marrow aspirates and peripheral blood samples will be collected at 48-72 hours post-enrollment for flow cytometric immunophenotyping of hematopoietic stem\u002Fprogenitor cells, MDSC subsets, and PD-L1 expression, as well as cytokine profiling and exploratory single-cell transcriptomics. Rectal swabs will be collected synchronously for 16S rRNA sequencing and untargeted metabolomics to investigate the association between gut microbiota, microbial metabolites, and bone marrow myeloid skewing, testing the gut-bone marrow-immune axis hypothesis. Clinical severity (SOFA\u002FAPACHE II), secondary infections, and 90-day mortality will be assessed to evaluate prognostic value. By integrating bone marrow hematopoiesis, gut microbiome, and clinical outcomes, this study seeks to provide novel mechanistic insights into sepsis-induced immunoparalysis and identify potential biomarkers or therapeutic targets for immune restoration.",[28,29],[28,528,529,530],"Bone marrow","Myeloid bias","Prognosis","2026-06-18",{"date":533,"type":36},"2026-06-24",{"date":326,"type":22},{"date":536,"type":22},"2027-12-30",{"name":538,"class":43},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology",{"id":540,"slug":541,"hasResults":12,"nctId":542,"briefTitle":543,"officialTitle":544,"acronym":545,"eligibilityCriteria":546,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":547,"targetDuration":4,"studyType":80,"phases":4,"briefSummary":548,"conditions":549,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":551,"lastUpdatePostDateStruct":552,"startDateStruct":554,"completionDateStruct":556,"leadSponsor":557,"locationsCount":44},"100327767","does-urinary-timp2-and-igfbp7-can-identify-high-risk-patients-of-progression-from-mild-and-moderate-to-severe-acute-kidney-injury-during-septic-shock-100327767","NCT03547414","Does Urinary TIMP2 and IGFBP7 Can Identify High Risk Patients of Progression From Mild and Moderate to Severe Acute Kidney Injury During Septic Shock?","Does Urinary TIMP2 and IGFBP7 Can Identify High Risk Patients of Progression From Mild and Moderate to Severe Acute Kidney Injury During Septic Shock? HEMOCHECK","HEMOCHECK","Inclusion Criteria:\n\n* Age 18 or over\n* Septic shock (according to Bone's criteria) within 4 hours of introduction of catecholamines\n* AKI, characterized by a KDIGO score ≥ 1\n* Social security coverage\n\nExclusion Criteria:\n\n* AKI requiring emergency RRT (in the critical care physician's opinion).\n* Anuria\n* Stage 4-5 chronic kidney failure with a GFR below 30 ml\u002Fmin.\n* Rapidly progressing renal disorders (glomerulonephritis, HUS, blockage, etc.)\n* Obstructive AKI\n* Probable glomerular damage (nephritic syndrome, nephrotic syndrome, chronic glomerulonephritis)\n* Pregnancy or breastfeeding\n* Legal guardianship or lack of social security coverage.\n* Cardiocirculatory arrest\n* Life expectancy \\\u003C48 hours.\n* Child C cirrhosis\n* Prior occurrence of AKI during the current hospital stay\n* Transplantation\n* Subject participating in another study with an exclusion period ongoing at the time of the pre-inclusion",{"count":343,"type":22},"Septic shock is one of the leading causes of death in patients admitted to the intensive care unit (ICU). Acute kidney injury (AKI) occurs in almost 50% of septic patients and is associated with significant mortality. Progression to the last stage (KDIGO stage 3) of AKI is an important step in the disease, as it usually requires initiation of RRT. Renal biomarkers are unable to accurately identify those patients who will progress to severe AKI (KDIGO 3). However, identification of patients at risk of progression to severe AKI could help the clinician to initiate optimal therapy including RRT. A new urine test, the Nephrocheck™ corresponding to the product of the urinary concentrations of 2 markers of renal tubule injury (TIMP2 and IGFBP7) has been validated. The Investigator have already performed two previous studies including septic shock patients (AKICHECK and BIOOCHECK). those previous datas will be reanalysed to examine whether the new urinary biomarkers TIMP2 and IGFBP7 can predict progression within 24 hours and 72 hours from mild and moderate (KDIGO 1 or 2) to severe AKI (KDIGO 3) in patients with septic shock.\n\n-All the datas required will be collected from two previous studies (AKICHECK and BIOCHECK) performed in 3 centers: Amiens medical ICU, Melun medico surgical ICU and Montpellier Medical ICU.",[550,29],"Acute Kidney Injury","2026-06-15",{"date":553,"type":36},"2026-06-16",{"date":555,"type":36},"2018-05-16",{"date":492,"type":22},{"name":558,"class":43},"Centre Hospitalier Universitaire, Amiens",{"id":560,"slug":561,"hasResults":12,"nctId":562,"briefTitle":563,"officialTitle":564,"acronym":4,"eligibilityCriteria":565,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":52,"enrollmentInfo":566,"targetDuration":4,"studyType":23,"phases":568,"briefSummary":569,"conditions":570,"keywords":572,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":579,"lastUpdatePostDateStruct":580,"startDateStruct":581,"completionDateStruct":583,"leadSponsor":584,"locationsCount":204},"100641364","effects-of-esmolol-on-sublingual-microcirculation-and-vascular-waterfall-phenomenon-in-patients-with-septic-shock-100641364","NCT07657754","Effects of Esmolol on Sublingual Microcirculation and Vascular Waterfall Phenomenon in Patients With Septic Shock","Effects of Esmolol on Sublingual Microcirculation and Vascular Waterfall Phenomenon in Patients With Septic Shock: A Prospective, Multicenter, Single-arm, Open-label, Pilot Physiological Study","Inclusion Criteria:\n\nAge 18-85 years. Diagnosis of septic shock according to Sepsis-3 criteria, requiring norepinephrine to maintain MAP ≥65 mmHg after adequate fluid resuscitation.\n\nPersistent tachycardia after initial hemodynamic optimization, adequate analgesia\u002Fsedation, and correction of reversible causes, defined as heart rate ≥95 beats\u002Fmin.\n\nContinuous norepinephrine infusion for ≥6 hours, with norepinephrine dose ≥0.10 μg\u002Fkg\u002Fmin at enrollment.\n\nAdequate volume status or absence of fluid responsiveness assessed by dynamic indices, echocardiography, or advanced hemodynamic monitoring; if PiCCO is used, GEDVI \\>700 mL\u002Fm² and\u002For ITBVI \\>850 mL\u002Fm² may be used as supportive criteria.\n\nPreserved or hyperdynamic cardiac function before esmolol initiation, defined as cardiac index \\>3.0 L\u002Fmin\u002Fm² or absence of severe septic cardiomyopathy.\n\nAbility to obtain sublingual microcirculatory images of acceptable quality at baseline.\n\nWritten informed consent obtained from the patient or legally authorized representative.\n\nExclusion Criteria:\n\nShock mainly caused by non-septic etiologies, including cardiogenic, hypovolemic, obstructive, hemorrhagic, or anaphylactic shock.\n\nSevere cardiac dysfunction or severe septic cardiomyopathy, including cardiac index \\\u003C2.2 L\u002Fmin\u002Fm² despite adequate preload, severe ventricular dysfunction, or need for inotropic agents at enrollment.\n\nUse of β-blockers before ICU admission or within 24 hours before enrollment. Contraindications to esmolol or β-blockade, including high-grade atrioventricular block without pacing, severe bradycardia, sick sinus syndrome, severe bronchospasm\u002Fasthma, or known allergy to esmolol.\n\nSevere structural heart disease or major pulmonary conditions affecting hemodynamics or safety, including severe valvular disease, significant congenital heart disease, cardiomyopathy, severe pulmonary bullae, or untreated pneumothorax.\n\nAcute coronary syndrome, life-threatening arrhythmia, or cardiac arrest before enrollment during the current ICU stay.\n\nConditions interfering with sublingual microcirculatory assessment, including major oral\u002Fsublingual lesions, active oral bleeding, inability to access the sublingual area, or poor baseline image quality.\n\nPregnancy or lactation, expected death or withdrawal of life-sustaining treatment within 24 hours, expected ICU stay \\\u003C48 hours, or inability to obtain informed consent.",{"count":567,"type":22},20,[25],"This prospective, multicenter, single-arm interventional pilot study aims to evaluate the short-term physiological effects of intravenous esmolol on sublingual microcirculation and vascular-waterfall parameters in adult patients with septic shock. Eligible patients will have septic shock according to Sepsis-3 criteria, persistent tachycardia after initial hemodynamic optimization, ongoing norepinephrine support, adequate volume status or absence of significant fluid responsiveness, and preserved or hyperdynamic cardiac function.\n\nApproximately 20 patients will be enrolled from participating intensive care units. After baseline assessment, participants will receive continuous intravenous esmolol infusion according to the study protocol and clinical safety criteria. Sublingual microcirculatory variables, including microvascular flow index, perfused vessel density, proportion of perfused vessels, and heterogeneity index, as well as vascular-waterfall parameters, including estimated critical closing pressure, estimated mean systemic filling pressure, and the Pcc-Pmsf gradient, will be measured at baseline and at 3, and 6 hours after esmolol initiation. Additional systemic hemodynamic, perfusion, vasopressor, and safety variables will also be collected.\n\nThe primary objective is to characterize immediate changes in sublingual microcirculation and vascular-waterfall physiology after esmolol administration and to provide preliminary data for the design of future controlled studies.",[29,28,571],"Critical Illness Sepsis, Severe",[573,574,575,576,577,578,29],"esmolol","sublingual microcirculation","microvascular flow index","critical closing pressure","mean systemic filling pressure","vascular waterfall","2026-06-14",{"date":531,"type":36},{"date":582,"type":22},"2026-08-01",{"date":536,"type":22},{"name":585,"class":43},"First Affiliated Hospital of Wannan Medical College",{"id":587,"slug":588,"hasResults":12,"nctId":589,"briefTitle":590,"officialTitle":591,"acronym":4,"eligibilityCriteria":592,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":52,"enrollmentInfo":593,"targetDuration":4,"studyType":23,"phases":594,"briefSummary":595,"conditions":596,"keywords":600,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":579,"lastUpdatePostDateStruct":610,"startDateStruct":611,"completionDateStruct":612,"leadSponsor":613,"locationsCount":204},"100641345","papaverine-and-sublingual-microcirculation-in-septic-shock-100641345","NCT07657741","Papaverine and Sublingual Microcirculation in Septic Shock","Effects of Papaverine on Sublingual Microcirculation and Vascular Waterfall Phenomenon in Patients With Septic Shock: A Prospective, Multicenter, Single-arm, Open-label, Pilot Physiological Study","Inclusion Criteria:\n\n* Age 18-85 years.\n* Septic shock according to Sepsis-3 criteria, defined as suspected or documented infection requiring vasopressors to maintain mean arterial pressure ≥65 mmHg and serum lactate \\>2 mmol\u002FL after adequate fluid resuscitation.\n* Enrollment within 24 hours after diagnosis of septic shock in the ICU.\n* Receiving continuous norepinephrine infusion at enrollment.\n* Receiving invasive mechanical ventilation at enrollment, allowing assessment of vascular waterfall-related hemodynamic variables.\n* PiCCO-based hemodynamic monitoring, invasive arterial pressure monitoring, and central venous access available before papaverine administration.\n* Ability to obtain sublingual microcirculatory images of acceptable quality at baseline.\n* Written informed consent obtained from the patient or legally authorized representative.\n\nExclusion Criteria:\n\n* Shock primarily caused by non-septic etiologies, including cardiogenic, hypovolemic, obstructive, hemorrhagic, or anaphylactic shock.\n* Expected death or planned withdrawal of life-sustaining treatment within 24 hours.\n* Known allergy or hypersensitivity to papaverine.\n* Severe hemodynamic instability judged unsuitable for papaverine by the treating physician, including refractory hypotension or rapidly escalating vasopressor requirement.\n* Clinically significant arrhythmia, high-grade atrioventricular block, acute coronary syndrome, or active myocardial ischemia before enrollment.\n* Severe hepatic dysfunction judged by the investigator to substantially increase the risk of papaverine-related adverse effects.\n* Conditions preventing reliable sublingual microcirculatory assessment, including major oral or sublingual lesions, active oral bleeding, inability to access the sublingual area, or poor baseline image quality.\n* Pregnancy or lactation.\n* Participation in another interventional clinical trial that may affect study outcomes or safety.",{"count":567,"type":22},[25],"This is a prospective, multicenter, single-arm, open-label, pilot physiological study designed to evaluate the effects of intravenous papaverine on sublingual microcirculation and the vascular waterfall phenomenon in adult patients with septic shock.\n\nEligible patients will have septic shock according to Sepsis-3 criteria, require norepinephrine support after adequate fluid resuscitation, and have PiCCO-based hemodynamic monitoring available before papaverine administration. Papaverine will be administered as an intravenous infusion of 30 mg over 10 minutes, followed by a continuous infusion of 2-5 mg\u002Fhour. Sublingual microcirculatory variables, vascular-waterfall-related indices, PiCCO-derived hemodynamic variables, macrocirculatory parameters, tissue perfusion variables, vasopressor dose, and safety outcomes will be assessed before and after papaverine administration.\n\nThe study aims to explore whether papaverine can improve microvascular perfusion and reduce microcirculatory flow impairment in septic shock, and to provide preliminary physiological and safety data for future controlled trials.",[29,597,598,599],"Microcirculatory Dysfunction","Sublingual Microcirculation","Hemodynamic Instability",[322,601,602,603,604,605,606,607,608,609],"Papaverine","Sublingual microcirculation","Microcirculatory dysfunction","Vascular waterfall phenomenon","Critical closing pressure","Perfused vessel density","Microvascular flow index","Proportion of perfused vessels","Pilot physiological study",{"date":531,"type":36},{"date":582,"type":22},{"date":536,"type":22},{"name":585,"class":43},{"id":615,"slug":616,"hasResults":12,"nctId":617,"briefTitle":618,"officialTitle":619,"acronym":620,"eligibilityCriteria":621,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":52,"enrollmentInfo":622,"targetDuration":4,"studyType":23,"phases":623,"briefSummary":624,"conditions":625,"keywords":627,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":579,"lastUpdatePostDateStruct":636,"startDateStruct":637,"completionDateStruct":638,"leadSponsor":639,"locationsCount":204},"100641303","effects-of-dexmedetomidine-on-sublingual-microcirculation-and-vascular-waterfall-phenomenon-in-patients-with-septic-shock-100641303","NCT07657715","Effects of Dexmedetomidine on Sublingual Microcirculation and Vascular Waterfall Phenomenon in Patients With Septic Shock","Effects of Dexmedetomidine on Sublingual Microcirculation and Vascular Waterfall Phenomenon in Patients With Septic Shock: A Prospective, Multicenter, Single-arm, Open-label, Pilot Physiological Study","DEX-MICRO","Inclusion Criteria:\n\n* Age 18-85 years.\n* Diagnosis of septic shock according to Sepsis-3 criteria, defined as suspected or documented infection with vasopressor requirement to maintain mean arterial pressure ≥65 mmHg and serum lactate \\>2 mmol\u002FL after adequate fluid resuscitation.\n* Enrollment within 24 hours after diagnosis of septic shock in the ICU.\n* Receiving invasive mechanical ventilation.\n* Receiving continuous intravenous sedative and\u002For analgesic therapy other than dexmedetomidine before enrollment, with a clinical decision to add dexmedetomidine for sedation management.\n* Continuous norepinephrine infusion at enrollment.\n* PiCCO catheter in place and PiCCO-based hemodynamic monitoring available before dexmedetomidine initiation.\n* Written informed consent obtained from the patient or legally authorized representative.\n\nExclusion Criteria:\n\n* Shock primarily caused by non-septic etiologies, including cardiogenic, hypovolemic, obstructive, hemorrhagic, or anaphylactic shock.\n* Expected death or withdrawal of life-sustaining treatment within 24 hours.\n* Known allergy or hypersensitivity to dexmedetomidine.\n* Severe bradycardia or clinically significant conduction abnormality before enrollment, including heart rate \\\u003C50 beats\u002Fmin, second-degree or third-degree atrioventricular block, sick sinus syndrome, or other conduction abnormality without a functioning pacemaker.\n* Severe uncontrolled arrhythmia, acute coronary syndrome, or clinically significant myocardial ischemia before enrollment.\n* Severe hemodynamic instability judged unsuitable for dexmedetomidine by the treating physician, including refractory hypotension or rapidly escalating vasopressor requirement.\n* Severe hepatic dysfunction judged by the investigator to substantially increase the risk of dexmedetomidine accumulation or adverse effects.\n* Conditions interfering with sublingual microcirculatory assessment, including major oral or sublingual lesions, active oral bleeding, inability to access the sublingual area, or poor baseline image quality.\n* Pregnancy or lactation.\n* Participation in another interventional clinical trial that may affect study outcomes or safety.",{"count":567,"type":22},[25],"This prospective, multicenter, single-arm, open-label interventional pilot study aims to evaluate the short-term physiological effects of intravenous dexmedetomidine on sublingual microcirculation and vascular-waterfall parameters in adult patients with septic shock.\n\nEligible patients will have septic shock according to Sepsis-3 criteria, require norepinephrine support after adequate fluid resuscitation, receive invasive mechanical ventilation, and have PiCCO-based hemodynamic monitoring available before dexmedetomidine initiation. After baseline assessment, participants will receive intravenous dexmedetomidine according to the study protocol. Dexmedetomidine will be administered as a continuous intravenous infusion at 0.2-0.7 µg\u002Fkg\u002Fhour without a loading dose. The infusion rate may be adjusted according to the target sedation level, hemodynamic status, and adverse effects.\n\nSublingual microcirculatory variables, including microvascular flow index, perfused vessel density, proportion of perfused vessels, and heterogeneity index, as well as vascular-waterfall parameters, including estimated critical closing pressure, estimated mean systemic filling pressure, and the Pcc-Pmsf gradient, will be measured at baseline, 3 hours, and 6 hours after initiation of dexmedetomidine. Systemic hemodynamic, perfusion, vasopressor, PiCCO-derived, sedation-related, and safety outcomes will also be collected.\n\nThe primary objective is to characterize immediate changes in sublingual microcirculation and vascular-waterfall physiology after dexmedetomidine administration and to provide preliminary data for future controlled studies.",[29,28,626],"Critical Illness",[628,31,574,575,578,576,577,629,630,631,632,633,634,635,273],"dexmedetomidine","Pcc","Pmsf","PiCCO","mechanical ventilation","sedation","bradycardia","hypotension",{"date":531,"type":36},{"date":582,"type":22},{"date":536,"type":22},{"name":585,"class":43}]