[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"sepsis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:sepsis":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,296,0,25,[9,45,74,105,128,161,189,215,252,278,306,332,359,387,409,437,462,492,508,530,553,575,595,611,638],{"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":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":23,"phases":55,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":73},"100581771","phase-1-a-study-to-learn-about-how-safe-bay-3389934-is-its-suitable-dose-and-how-it-affects-the-participants-with-sepsis-induced-coagulopathy-100581771","NCT06854640","A Study to Learn About How Safe BAY 3389934 is, Its Suitable Dose, and How it Affects the Participants With Sepsis Induced Coagulopathy","First in Patient, Dose Escalation, Open Label Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous Infusion of BAY 3389934 to Patients With Sepsis Induced Coagulopathy","Inclusion Criteria:\n\n* Participant must be ≥ 18 and ≤ 80 years of age at the time of signing the informed consent.\n* Participants with diagnosed sepsis according to sepsis-3 criteria. Sepsis is defined as life-threatening organ dysfunction caused by a dysregulated host response to infection.\n* participants with suspected or documented origin of infection.\n* Participants with coagulopathy defined by at least one of the following within 24 hours prior start of study intervention: INR ≥1.40, platelet count in the range of ≥ 30,000\u002Fmm3 to \\\u003C 150,000\u002Fmm3 OR greater than 30% decrease in platelets in 24 hours without other known etiology. The platelet count after decrease should not be \\\u003C 30,000\u002Fmm3.\n* Participants must be receiving treatment in an ICU.\n* Informed consent of capable participant or, in case of participant being incapable of giving informed consent, consent for study inclusion will be sought according to applicable laws and regulations.\n\nExclusion Criteria:\n\n* Clinically significant active bleeding; known bleeding disorder, history of major traumatic or non-traumatic bleeding (intracranial, retroperitoneal, intraocular) or clinically significant gastrointestinal bleeding within last 6 months.\n* Low platelets level or abnormal coagulation status due to any other reason than sepsis.\n* Participants with indication for therapeutic dose of: anticoagulation (heparin, argatroban, vitamin K antagonists\u002Fwarfarin, dabigatran, apixaban, rivaroxaban, edoxaban), oral antiplatelet agents (clopidogrel, ticagrelor, ticlopidine, prasugrel) except low dose (≤100mg) acetyl salicylic acid (ASA), digoxin, metformin\n* Any active malignancy\n* Pregnancy or breastfeeding.\n* Chronic liver disease Child-Pugh Class C.\n* Participants experienced major surgery or major trauma (intrathoracic, intra-abdominal, pelvic or femur) or surgery\u002Ftrauma in any other area with potentially clinically significant consequences due to bleeding within 28 days before study drug administration.\n* Participants experienced neurotrauma or neurosurgery (brain, spine) or orthopedic surgery in spine within 6 months before study drug administration","80 Years",{"count":54,"type":22},36,[56],"PHASE1","Researchers are looking for a better way to treat people who have sepsis induced coagulopathy.\n\nSepsis happens when bacteria and their toxins spread in the blood, causing an infection. To overcome the infection the body responds activating the immune system, sometimes this immune response is too active and causes uncontrolled blood clot formation, also called sepsis-induced coagulopathy. Sepsis coagulopathy damages blood vessels and organs and leads to low platelet levels in the body. In severe cases, it can even lead to death.\n\nThe main purpose of this first in patient study is to learn about how safe BAY 3389934 is, its suitable dose, and how it affects the participants with sepsis induced coagulopathy. For this study, researchers will enroll people receiving treatment for sepsis induced coagulopathy in a hospital intensive care unit (ICU).\n\nFor this, the researchers will collect the number of participants with medical problems during and after receiving BAY 3389934. These medical problems are also known as \"adverse events\". Doctors keep track of all medical problems that happen in studies, even if they do not think they might be related to the study treatments.\n\nParticipants will be divided into 2 groups. The first group will receive the lowest starting dose of BAY3389934. The researcher will carefully monitor how the participant responds to the medication and may adjust the dose, either increasing or decreasing it based on the safety and the tolerability of the drug. If no serious side effects are reported from the first group, the second group will receive higher dose of BAY3389934.\n\nEach participant will be in the study for around 28 days. During the study, the doctors and their study team will:\n\n* Take blood and urine samples,\n* Do physical examinations,\n* Check vital signs such as body temperature, blood pressure and heart rate,\n* Examine heart health using electrocardiogram (ECG)",[28,59],"Coagulopathy",[61,62,63],"DIC","Disseminated intravascular coagulation","Sepsis induced coagulopathy",{"date":65,"type":36},"2026-08-20",{"date":67,"type":36},"2025-03-12",{"date":69,"type":22},"2027-01-17",{"name":71,"class":72},"Bayer","INDUSTRY",20,{"id":75,"slug":76,"hasResults":12,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":82,"enrollmentInfo":83,"targetDuration":4,"studyType":23,"phases":85,"briefSummary":86,"conditions":87,"keywords":92,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":44},"100652823","icu-succeed-for-survivors-of-acute-respiratory-failure-and-their-caregivers-100652823","NCT07778004","ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers","A Pilot Randomized Trial of the Self-Management Using Couples' Coping EnhancEment in Diseases Intervention for Survivors of Acute Respiratory Failure and Their Family Caregivers","ICU-SUCCEED","Patient Inclusion Criteria\n\n* Admitted to the medical ICU at UNC with acute respiratory failure (functional lung impairment resulting in hypoxia, hypercapnia, or both) and\u002For sepsis with significant end organ dysfunction.\n* At least 18 years old\n* Survives to hospital discharge\n* Is expected to be discharged home or to an acute inpatient rehabilitation center with a clear plan to be subsequently discharged home\n* Capable of providing written informed consent\n* Has English language proficiency\n\nCaregiver Inclusion Criteria\n\n* Provides emotional, physical, and\u002For financial support to the patient in a non-professional, unpaid capacity\n* Must be related to the patient in one of the following ways: a spouse or domestic partner, an adult child, a parent, or a sibling\n* At least 18 years of age\n* Has English language proficiency\n* Must be the caregiver of a patient that meets the patient eligibility criteria listed above\n\nPatient Exclusion Criteria:\n\n* No available family caregiver\n* Lacks decision-making capacity\n* Under 18 years of age\n* Living at a location other than home prior to admission\n* Unhoused prior to admission\n* Receives extracorporeal membrane oxygenation (ECMO) during hospital stay\n* Expected to discharge to any location other than home or an acute inpatient rehabilitation center\n* Does not have English language proficiency\n\nCaregiver Exclusion Criteria\n\n* Does not provide emotional, physical, and\u002For financial support to the patient in a non-profession, unpaid capacity\n* Is not related to the patient in one of the following ways: a spouse or domestic partner, an adult child, a parent, or a sibling\n* Cannot complete surveys or engage in other study activities due to physical or cognitive limitations\n* Unhoused prior to admission\n* Is under 18 years of age\n* Does not have English language proficiency\n* Is not the caregiver of a patient that meets the patient eligibility criteria listed above","99 Years",{"count":84,"type":22},144,[25],"This study will investigate whether a family-centered intervention that has been adapted for patients with critical illness and their caregivers is possible, acceptable, and helpful",[88,89,28,90,91],"Acute Respiratory Failure","Critical Illness","Hypoxia","Hypercapnia",[88,93,94,28,95],"Family-Centered Intervention","Critical illness","Septic shock","NOT_YET_RECRUITING","2026-08-18",{"date":35,"type":36},{"date":100,"type":22},"2026-09-01",{"date":102,"type":22},"2030-09-01",{"name":104,"class":43},"University of North Carolina, Chapel Hill",{"id":106,"slug":107,"hasResults":12,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":112,"sex":18,"minAge":19,"maxAge":113,"enrollmentInfo":114,"targetDuration":4,"studyType":116,"phases":4,"briefSummary":117,"conditions":118,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":44},"100447784","dysfunctional-myelopoiesis-and-myeloid-derived-suppressor-cells-in-sepsis-100447784","NCT05110937","Dysfunctional Myelopoiesis and Myeloid-Derived Suppressor Cells in Sepsis","Dysfunctional Myelopoiesis and Myeloid-Derived Suppressor Cells in Sepsis Pathobiology Subtitle: Pathological Myeloid Activation After Sepsis and Trauma","Sepsis participant:\n\nInclusion Criteria:\n\n1. age ≥18 years\n2. meets criteria for sepsis\u002Fseptic shock by Sepsis-3 consensus criteria.\n\nExclusion Criteria:\n\n1. have disease states that predispose to significant immune system dysfunction\n2. have comorbidity burden or goals of care that preclude recovery after sepsis. These criteria include:\n\n   a. irreversible shock (death \\\u003C12 hours) b. uncontrollable surgical source of sepsis c. patients deemed to be futile care or have advanced directives limiting resuscitative efforts d. alternative diagnoses causing shock state (e.g., hemorrhage, myocardial infarction or pulmonary embolus) e. known HIV infection with CD4+ count \\\u003C200 cells\u002Fmm3 g. severe traumatic brain injury with unencumbered assessment of GCS equaling 3 on admission to the intensive care unit.\n3. known pregnancy\n4. enrollment \\>96 hours after suspected sepsis onset\n5. pre-hospitalization bedridden performance status (WHO\u002FZubrod score ≥4)\n6. subsequent clinical adjudication diagnosis not consistent with sepsis\u002Fseptic shock by Sepsis-3 criteria.\n7. Burn injury greater than 20% total body surface area (tBSA)\n\nTrauma Participant:\n\nInclusion Criteria\n\n1. All adults age ≥ 18 years\n2. Blunt trauma patient with a. Injury Severity Score (ISS) greater than or equal to 25 b. ISS \\> 15 and one of the following: i. \\> 4 units of PRBC or \\>3 units of whole blood or \\>1500 ml of autogenous blood product in the first 24 hours of admission ii. AIS (acute injury score) \\> 2 spine iii. Shock on arrival (Systolic blood pressure (SBP) \\\u003C 90)\n\nOR\n\nc. ISS \\> 15 and two of the following: i. Age \\> 55 ii. AIS \\> 2 chest iii. +ETOH (ethyl alcohol) on arrival iv. Any red blood cell transfusion in first 24 hours\n\nExclusion Criteria\n\n1. Patients not expected to survive greater than 48 hours.\n2. Prisoners.\n3. Pregnancy.\n4. Previous bone marrow transplantation.\n5. Patients with End Stage Renal Disease.\n6. Patients with any pre-existing hematological disease.\n7. Patients deemed to be futile care or have advanced directives limiting resuscitative efforts.\n8. Known HIV infection with CD4+ count \\\u003C200 cells\u002Fmm3\n9. Burn injury greater than 20% tBSA",true,"100 Years",{"count":115,"type":22},450,"OBSERVATIONAL","Adverse outcomes in surgical sepsis patients are secondary to dysregulated emergency myelopoiesis, and expansion of myeloid-derived suppressor cells. Here we propose to determine the underlying mechanisms behind the increased expansion of these leukocyte populations and the underlying mechanisms that drive inflammation and immune suppression.",[28,119],"Trauma Injury","2026-08-17",{"date":33,"type":36},{"date":123,"type":36},"2022-01-04",{"date":125,"type":22},"2029-04-01",{"name":127,"class":43},"University of Florida",{"id":129,"slug":130,"hasResults":12,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":134,"eligibilityCriteria":135,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":136,"targetDuration":4,"studyType":23,"phases":138,"briefSummary":140,"conditions":141,"keywords":144,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":155,"completionDateStruct":156,"leadSponsor":158,"locationsCount":160},"100635701","phase-4-the-vancomycin-piperacillintazobactam-vpt-patient-safety-trial-vps-100635701","NCT07556107","The Vancomycin Piperacillin\u002FTazobactam (VPT) Patient Safety Trial (VPS)","A Randomized Controlled Trial Comparing Renal Effects of Vancomycin Combined With Either Piperacillin\u002FTazobactam or Meropenem: VPT Patient Safety (VPS) Study","VPS","Inclusion criteria\n\n1. Hospitalized or being hospitalized.\n2. Age \\>\u002F=18 yr old.\n3. Serious or suspected serious infection for which VPT or VM considered a broad-spectrum combination antibiotic backbone standard of care by clinician.\n4. Enrollment can be completed before the first dose of abx (ideally) and no later than before the second dose (alternatively).\n5. Consenting\u002Fenrollment will not clinically significantly delay abx administration.\n6. Baseline and \\>\u002F=1 prior Scr available (within 1 yr).\n7. Pt or LAR able to provide IC. Exclusion criteria\n\n1\\. AKI (\\>\u002F=moderate) (KDIGO stage 2-3) (Scr increase \\>\u002F=2-fold from chronic BL) (Scr based).\n\n2\\. CKD (\\>\u002F=moderately to severely decreased eGFR) (KDIGO stage G3b-G5) (by history or eGFR \\\u003C\u002F=44 mL\u002Fmin\u002F1.73M2) (Scr based).\n\n3\\. Beta lactam allergy. 4. Contraindication to VPT or VM. 5. Infection requiring VPT or VM specifically or another abx regimen. 6. Participation in another research study with interventions that may impact study endpoints.",{"count":137,"type":22},852,[139],"PHASE4","The VPT Safety Trial (VPS) compares two common antibiotic combinations to see how they affect the kidneys of patients in the hospital with serious infections. Both combinations are approved by the Food and Drug Administration (FDA). The goal is to help doctors know which combination is safer so they can make better choices for their patients.",[142,143,28],"Infection","Acute Kidney Injury",[145,146,147,148,149,150,151,152],"infection","hospitalized","AKI","cystatin c","vancomycin","piperacillin\u002Ftazobactam","meropenem","RCT","2026-08-16",{"date":97,"type":36},{"date":120,"type":22},{"date":157,"type":22},"2028-12-31",{"name":159,"class":43},"Bassett Healthcare",3,{"id":162,"slug":163,"hasResults":12,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":167,"eligibilityCriteria":168,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":169,"targetDuration":4,"studyType":116,"phases":4,"briefSummary":171,"conditions":172,"keywords":173,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":184,"completionDateStruct":185,"leadSponsor":187,"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":170,"type":22},100,"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],[174,175,176,177,178,179,180,181],"Capillary Refill Time","Oxygen Extraction Ratio","Tissue Perfusion","ScvO2","Microcirculation","Hemodynamic Coherence","Lactate","Observational Cohort Study","2026-08-15",{"date":33,"type":36},{"date":120,"type":22},{"date":186,"type":22},"2027-07-17",{"name":188,"class":43},"Istanbul University - Cerrahpasa",{"id":190,"slug":191,"hasResults":12,"nctId":192,"briefTitle":193,"officialTitle":193,"acronym":194,"eligibilityCriteria":195,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":196,"targetDuration":198,"studyType":116,"phases":4,"briefSummary":199,"conditions":200,"keywords":203,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":209,"startDateStruct":210,"completionDateStruct":211,"leadSponsor":213,"locationsCount":44},"100644641","t6a-biomarker-for-detection-of-bacterial-infection-in-newborn-infants-100644641","NCT07670624","T6A Biomarker for Detection of Bacterial Infection in Newborn Infants","T6ASepsis","Inclusion Criteria:\n\n* Newborn infants who require blood testing for screening for bacterial infection OR treating physician suspects bacterial infection in newborn infant\n* Signed informed consent form\n\nExclusion Criteria:\n\n1. Refusal to participate in study or not providing written informed consent by caregivers\u002Fparents\n2. Antibiotic treatment of any kind.",{"count":197,"type":22},210,"1 Week","This study aims to assess the efficacy of a new biomarker, N6-threonylcarbamoyladenosine (t6A), for the early diagnosis of Early-Onset Sepsis (EOS) in newborns.",[28,201,202],"Newborn Sepsis","Biomarker Discovery",[204,205,206,207],"t6a","newborn sepsis","infectious disease biomarker","biomarker","2026-08-13",{"date":120,"type":36},{"date":100,"type":22},{"date":212,"type":22},"2029-01-31",{"name":214,"class":43},"Salzburger Landeskliniken",{"id":216,"slug":217,"hasResults":12,"nctId":218,"briefTitle":219,"officialTitle":219,"acronym":220,"eligibilityCriteria":221,"healthyVolunteers":112,"sex":18,"minAge":222,"maxAge":223,"enrollmentInfo":224,"targetDuration":4,"studyType":23,"phases":226,"briefSummary":229,"conditions":230,"keywords":234,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":244,"startDateStruct":245,"completionDateStruct":247,"leadSponsor":249,"locationsCount":251},"100584790","phase-3-limited-versus-extended-trophic-feeding-let-feed-trial-100584790","NCT06893939","Limited Versus Extended Trophic Feeding (LET-FEED) Trial","LET-FEED","Inclusion Criteria:\n\n* \\\u003C1500 gram birthweight\n* 25w0d-31w6d at birth\n* Consent to feed donor milk when parent's own milk is not available or of insufficient quantity\n\nExclusion Criteria:\n\n* \\\u003C5th percentile for weight at birth (Fenton growth curve)\n* Parent or legal guardian unable to provide consent within 36 hours after birth\n* Congenital anomaly affecting decisions on enteral feedings (e.g. gastroschisis, omphalocele, congenital diaphragmatic hernia, congenital heart disease, etc.)\n* Known genetic condition affecting growth, feeding, or mortality\n* Vasopressor use within first 24 hours after birth (not including hydrocortisone)\n* Considered terminally ill","0 Years","2 Years",{"count":225,"type":22},350,[227,228],"PHASE2","PHASE3","Study Hypothesis\u002FQuestion In infants born very preterm, advancing enteral feeds after 24 hours from birth (limited trophic feeds) versus after 72 hours (extended trophic feeds) reduces the risk of all-cause late onset sepsis (LOS) without increasing the risk of other adverse outcomes.\n\nStudy Design Type This is a multi-center, open-label, parallel-group, individual randomized controlled trial comparing two different trophic feeding regimens in preterm infants born between 25w0d and 31w6d. These infants will be randomly assigned to either the intervention group, receiving limited trophic feeding (20 to 25 mL\u002Fkg\u002Fday for one day) or the control group, receiving extended trophic feeding (20 to 25 mL\u002Fkg\u002Fday for three days) prior to advancing enteral feeds until full feeding volume (140 mL\u002Fkg\u002Fday) is achieved.\n\nEligibility Criteria Preterm infants with gestational ages between 25 0\u002F7 and 31 6\u002F7 weeks and a birthweight of \\\u003C1500 grams who are admitted to six participating neonatal units will be eligible for inclusion. Infants with \\\u003C5th percentile for weight at birth, vasopressor use within first 24 hours of life major congenital\u002Fgenetic anomalies affecting enteral feeding, growth, or mortality, and those with a terminal illness in which decisions to withhold or limit support have been made will be excluded. Infants of parents or legal guardians who are unable to provide consent within 36 hours of birth will also be excluded.\n\nStudy Intervention\u002FMethods Written parental informed consent will be obtained prenatally or within the first 36 hours of birth. Infants will be randomized to receive limited trophic feeds of 24 to 36 hours or extended trophic feeds for 72 hours prior to the advancement of enteral feeds. Infants will be fed parent's own milk (POM) with donor human milk as the alternative if POM is unavailable.\n\nPrimary Outcome Late-onset sepsis, defined as positive blood, urine, and\u002For cerebrospinal fluid (CSF) cultures in the presence of compatible clinical signs of sepsis, occurring after postnatal day 3 and before hospital discharge, and treated with antibiotics for 5 days or more.\n\nSecondary Outcome(s) The trial will assess various secondary outcomes including length of hospital stay, all-cause in-hospital mortality, duration of IV fluids and central line utilization, necrotizing enterocolitis (Bell's stage IIa or higher), severe intraventricular hemorrhage (grade III or IV either unilaterally or bilaterally), bronchopulmonary dysplasia (oxygen requirement or positive pressure ventilation at 36 weeks corrected gestational age), or retinopathy of prematurity requiring intervention. Additionally, growth metrics throughout hospitalization will be evaluated using change in weight, length, and head circumference z-scores from birth to 36 weeks' corrected gestational age between infants in the limited and extended trophic feeding groups.\n\nWe will also evaluate the 2 year developmental outcomes of a subset of participants who consent to follow up. This will include the Bayley Scales of Infant and Toddler Development-4th edition Language, Cognitive, and Motor domain scores at 2 years corrected age.",[28,231,232,233],"Length of Stay","Mortality","Neurodevelopmental Delay",[235,236,237,238,239,240,241,242,243],"Feeding","Nutrition","Prematurity","Very preterm","Trophic","Trophic feeds","Trophic feeding","enteral feeds","sepsis",{"date":120,"type":36},{"date":246,"type":36},"2025-07-03",{"date":248,"type":22},"2031-02-28",{"name":250,"class":43},"University of Washington",6,{"id":253,"slug":254,"hasResults":12,"nctId":255,"briefTitle":256,"officialTitle":257,"acronym":258,"eligibilityCriteria":259,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":260,"targetDuration":4,"studyType":116,"phases":4,"briefSummary":262,"conditions":263,"keywords":268,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":271,"lastUpdatePostDateStruct":272,"startDateStruct":273,"completionDateStruct":274,"leadSponsor":276,"locationsCount":44},"100652456","point-of-care---sepsis-study-100652456","NCT07774013","Point of Care - Sepsis Study","Diagnostic Accuracy of Inflammatory Parameters for the Diagnosis of Early Onset Neonatal Sepsis and Differentiation Between Viral and Bacterial Infections in Preterm Infants Using a Point-of-care Device - a Pilot Study (POCT Sepsis)","POCT Sepsis","Inclusion Criteria:\n\n* Preterm neonates born at \\\u003C37+0 weeks of gestation who are admitted to the Division of Neonatology, Department of Pediatrics, Medical University of Graz after birth.\n* Written parental informed consent before birth.\n\nExclusion Criteria:\n\n* Term and preterm neonates who are not admitted to the neonatal care unit.\n* No point-of-care measurement of IL-6 and PCT in neonatal blood for infants who do not require blood gas analysis within the first 12 hours of life.",{"count":261,"type":22},80,"This pilot study will evaluate whether a rapid point-of-care blood test can help identify early signs of infection and sepsis in preterm infants. The study will include preterm infants born before 37 weeks of pregnancy who are admitted to the neonatal care unit and have a suspected infection.\n\nThe researchers will measure several substances in the blood that can increase during infection, including interleukin-6 (IL-6), procalcitonin (PCT), C-reactive protein (CRP), and myxovirus resistance protein A (MxA). Results obtained with the point-of-care device will be compared with standard laboratory measurements. The researchers will also study whether measuring IL-6 and PCT during the first 12 hours of life may provide useful information about infection earlier than CRP testing and whether combined MxA and CRP measurements may help distinguish bacterial from viral infections.\n\nThis is an observational study and will not change the infants' standard medical care or treatment. Results from the point-of-care device will not be used to make treatment decisions during the study. Blood samples will be collected as part of, or together with, routine blood sampling whenever possible. The study is expected to include approximately 40 preterm infants, with a maximum of 80 infants enrolled.",[264,28,265,266,267],"Neonate","IL6","PCT","Point of Care",[269,243,265,266,270],"neonate","Point of care","2026-08-12",{"date":33,"type":36},{"date":182,"type":22},{"date":275,"type":22},"2028-08-31",{"name":277,"class":43},"Medical University of Graz",{"id":279,"slug":280,"hasResults":12,"nctId":281,"briefTitle":282,"officialTitle":283,"acronym":284,"eligibilityCriteria":285,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":286,"targetDuration":288,"studyType":116,"phases":4,"briefSummary":289,"conditions":290,"keywords":291,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":271,"lastUpdatePostDateStruct":298,"startDateStruct":300,"completionDateStruct":302,"leadSponsor":304,"locationsCount":44},"100613957","a-study-on-how-the-immune-system-responds-to-sepsis-and-its-long-term-effects-100613957","NCT07273344","A Study on How the Immune System Responds to Sepsis and Its Long-term Effects","A Systems Immunology Approach to Characterize the Immune Response in Sepsis and Its Long-term Complications","HEAL-SEPSIS","Inclusion Criteria:\n\n* Adults (≥18years).\n* Sepsis 3 criteria: defined as having a suspected or documented infection accompanied by organ dysfunction, represented by a total Sequential Organ Failure Assessment (SOFA-2) score 2 or more for new admissions or as 2 or more point-increase of the total SOFA-2 score for hospitalized patients.\n\nExclusion Criteria:\n\n* Known chemotherapy-induced or long-term neutropenia.\n* Known CD4 counts \\\u003C400 cells\u002FµL.\n* History of primary immunodeficiency\n* Chronic intake of corticosteroids (defined as total daily dose equal or greater than 0.4 mg\u002Fkg of equivalent prednisone for more than the last 15 days).\n* Current use of biologics.\n* Solid organ transplant recipients.\n* Recipients of allogeneic bone marrow transplants.",{"count":287,"type":22},400,"1 Year","Sepsis occurs when an infection, caused by bacteria, a virus, or a fungus, enters the body and throws the immune system out of balance. Instead of protecting the body, the immune response may become too strong and start damaging healthy organs, or it may become too weak and fail to control the infection. Both situations can be life-threatening. Even people who survive sepsis may experience long-term health problems, such as new infections, heart and blood vessel diseases, or early death.\n\nThis study aims to better understand how the immune system behaves during and after sepsis. We believe that there are different types of immune responses in sepsis, called immunotypes. We will identify these immunotypes by examining substances in the blood and changes in immune cells. We will then study which immunotypes help protect patients and which may cause short- or long-term harm.\n\nUnderstanding these immunotypes may make it possible in the future to quickly determine what type of immune response a patient with sepsis has. This could help doctors choose the best treatment for each individual patient.\n\nA total of 400 patients with sepsis from the intensive care unit will take part in this study. We will collect blood samples at several time points and gather information about their health. Participants will be followed from their intensive care admission until one year after they return home.",[28],[292,243,293,294,295,296,297],"observational","cohort study","immune endotypes","endotypes","immunotypes","post-sepsis syndrome",{"date":299,"type":36},"2026-08-14",{"date":301,"type":36},"2025-11-03",{"date":303,"type":22},"2028-12-01",{"name":305,"class":43},"Radboud University Medical Center",{"id":307,"slug":308,"hasResults":12,"nctId":309,"briefTitle":310,"officialTitle":311,"acronym":312,"eligibilityCriteria":313,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":314,"targetDuration":4,"studyType":23,"phases":316,"briefSummary":317,"conditions":318,"keywords":319,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":324,"startDateStruct":325,"completionDateStruct":327,"leadSponsor":329,"locationsCount":331},"100624302","call-for-life-sepsis-100624302","NCT07407868","Call for Life Sepsis","Evaluating The Impact on 90-day Survival Of Post-Discharge Follow-up Strategies Delivered To Adult Patients Hospitalized With Sepsis Across A Research Network In Sub-Saharan Africa","C4L-Sepsis","Inclusion Criteria:\n\n* At admission\n\n  1. Adults ≥18 years.\n  2. Participant's hospital admission diagnosis is consistent with the following broad definition of sepsis, incorporating its principal components (signs of infection plus signs of severity\u002Forgan dysfunction):\n\n     1. Signs of infection: Suspected or proven infection, as determined by the medical team in charge.\n     2. Illness severity: Decision of the medical team to admit the patient to an adult medical ward of the study hospital, according to clinical appraisal of the treating physician and applicable guidelines.\n  3. Participant\u002Fproxy is willing to have their medical records reviewed by the trial team and get daily follow-ups until the time of discharge and to be approached again by the study team for a second informed consent process towards the time of hospital discharge.\n  4. Evidence of a personally signed and dated informed consent form stating that the participant\u002Fproxy has been informed of, had opportunity to ask questions about and have consented to the initial study procedures that will be conducted during their hospitalization. At discharge\n  5. Patient has overcome the critically ill phase of their hospitalization and is, according to the non-study clinical team caring for the patient, expected to be discharged within the next 24 hours.\n  6. Participant is willing and able to comply with scheduled phone follow-ups, and other study procedures.\n  7. Evidence of a personally signed and dated informed consent form stating that the participant has been informed of, had opportunity to ask questions about and have consented to all procedures that will be conducted at the time of and after their discharge, and alternatives and risks for the study.\n  8. The participant confirms that there is availability of mobile network coverage in their place of residence.\n\nExclusion Criteria:\n\nAt Admission;\n\n1. Patient who requires hospitalization for a condition that requires emergent or urgent obstetric or surgical intervention (including burns, trauma, abscess)\n2. Persons who are currently or have been previously enrolled into this study.\n3. Patient is terminally ill due to an underlying condition other than sepsis.\n4. The patient is a detainee or prisoner.\n5. The patient is unable to speak English and Luganda.\n\n   * At Discharge:\n\n   At discharge\n6. The patient is unable to hear.\n7. Participant states they will be unable to return to same health facility for the scheduled 14-day post-discharge clinic assessment (provided by the non-study clinical team)\n8. Patients requiring clinical care for more than 10 days (if clinical care was completed and participant is ready for discharge but are still in hospital for financial or logistical reasons beyond 10 days, they can still be eligible)",{"count":315,"type":22},1410,[25],"Sepsis is a life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis-attributable mortality in sub-Saharan Africa (sSA) is high, with in-hospital mortality in some settings approaching 40%. Studies show that mortality among children under 5 years hospitalized with sepsis remains high within the first 6 months of discharge. Additionally, high mortality has been observed among other populations within sSA, with factors such as HIV infection being associated with increased risk. Reducing sepsis deaths contributes to the achievement of the Sustainable Development Goals (SDG), particularly SDG 3 in reducing maternal mortality (3.1), neonatal and under five mortality (3.2), and burden of mortality from communicable diseases (3.3) and improving universal health coverage (3.8). The World Health Organization (WHO) has recognized sepsis as a global priority, with low- and middle-income settings being particularly affected. In sSA, sepsis is commonly associated with infectious diseases like malaria, Human Immunodeficiency Virus\u002F Acquired Immunodeficiency Syndrome (HIV\u002FAIDS), pneumonia, tuberculosis, and diarrhea. Guidelines from the Surviving Sepsis Campaign (SSC) have become standard in some settings. However, little is known about patients' status post-discharge. This study aims to evaluate two post-discharge follow-up strategies for adult sepsis patients. Study duration is 45 months, participants will receive intervention up to 90 days post discharge.\n\nDescription of intervention: Post-discharge follow-up strategy 1: Enhanced Discharge Intervention (EDI) Post-discharge follow-up strategy 2: EDI plus Interactive Voice Response (IVR)\n\n\\*All participants will receive a feature phone.\n\nObjectives:\n\nThe study aims to evaluate two post-discharge follow-up strategies for adult patients hospitalized with sepsis, focusing on their efficacy in reducing the 90-day mortality, and their effect on return to follow-up, number of re-admissions, and quality of life.\n\nPrimary efficacy endpoint\n\n* 90- day all-cause mortality post discharge Secondary end points\n* Time to death\n* 28-day all-cause mortality\n* Attendance within 14-day check-up post discharge\n* Re-admission within 28 and 90 days\n* Days alive and out of hospital (DAOH)\n* Quality of life score (Baseline vs 28 day and Baseline vs 90 days)\n* Differences in baseline demographic and clinical characteristics (e.g., age, sex, disease severity, comorbidities, key laboratory values) between randomized participants and screen failures. Study design: This is an open-label, randomized, parallel, interventional study, with two post-discharge follow-up strategies: 1) EDI; or 2) EDI plus IVR system. Fixed allocation randomization at a 1:1 ratio will be applied to either study arm.\n\nSample size: A total of 1,410 (705 per arm) from the four countries (Uganda, Nigeria, Ghana and Mozambique) will be enrolled competitively across the sites.",[28],[320,321,322],"Reduce post discharge sepsis mortality,","Interactive Voice Response System,","Call for life - IVR","2026-08-10",{"date":271,"type":36},{"date":326,"type":36},"2026-06-10",{"date":328,"type":22},"2028-06-15",{"name":330,"class":43},"Makerere University",2,{"id":333,"slug":334,"hasResults":12,"nctId":335,"briefTitle":336,"officialTitle":337,"acronym":4,"eligibilityCriteria":338,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":339,"enrollmentInfo":340,"targetDuration":4,"studyType":23,"phases":342,"briefSummary":343,"conditions":344,"keywords":346,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":352,"startDateStruct":353,"completionDateStruct":355,"leadSponsor":357,"locationsCount":44},"100575403","evaluation-of-pediatric-ecart-implementation-100575403","NCT06771830","Evaluation of Pediatric eCART Implementation","A Rapid Diagnostic of Risk in Hospitalized Pediatric Patients to Improve Outcomes Using Machine Learning","Inclusion Criteria (pediatric patients):\n\n* All pediatric patients scored on pediatric eCART (or eligible for scoring on either algorithm in the pre-implementation period) will be screened for study eligibility.\n* Patients eligible for pediatric eCART scoring include pediatric (\\\u003C18 years of age) patients\n* Inpatient locations\n\nExclusion Criteria (pediatric patients):\n\n* Patients who are ineligible for pediatric eCART scoring\n* Neonates and birth encounters will be excluded from the pediatric eCART study\n\nInclusion Criteria (nurse clinicians):\n\n* UW Health nurses who interact with eCART during patient care\n\nExclusion Criteria (nurse clinician):\n\n* UW Health nurses no longer employed at UW Health","17 Years",{"count":341,"type":22},30000,[25],"This is a study comparing 3 years of retrospective data (pre-implementation) to 2 years of prospective data after the implementation of a pediatric version of Electronic Cardiac Arrest Risk Triage (pediatric eCART), a clinical decision support (CDS) tool that uses electronic health records (EHR) to identify patients with high risk for life threatening outcomes. Up to 30,000 encounters with pediatric patients will be assessed. Acceptability of the pediatric eCART intervention will also be measured from pediatric nurse clinicians.",[345,28],"Pediatric ALL",[347,348,349,350,351],"machine learning","artificial intelligence","clinical decision support","triage","electronic medical records",{"date":208,"type":36},{"date":354,"type":36},"2025-12-01",{"date":356,"type":22},"2027-12",{"name":358,"class":43},"University of Wisconsin, Madison",{"id":360,"slug":361,"hasResults":12,"nctId":362,"briefTitle":363,"officialTitle":364,"acronym":4,"eligibilityCriteria":365,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":366,"enrollmentInfo":367,"targetDuration":4,"studyType":116,"phases":4,"briefSummary":369,"conditions":370,"keywords":374,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":379,"lastUpdatePostDateStruct":380,"startDateStruct":381,"completionDateStruct":383,"leadSponsor":385,"locationsCount":44},"100651520","eeg-changes-and-cognitive-profiles-in-sepsis-patients-with-different-inflammatory-phenotypes-100651520","NCT07760415","EEG Changes and Cognitive Profiles in Sepsis Patients With Different Inflammatory Phenotypes","Electroencephalogram Changes and Cognitive Function Profiles in Sepsis Patients With Different Inflammatory Phenotypes","Inclusion Criteria:\n\n* Age ≥18 years and ≤90 years\n* First-time admission to the Intensive Care Unit (ICU)\n* Diagnosis of sepsis according to Sepsis-3.0 criteria (documented or clinically suspected infection plus Sequential Organ Failure Assessment \\[SOFA\\] score ≥2 points)\n* Expected ICU survival time ≥24 hours\n* Written informed consent provided by the patient or legal surrogate\n\nExclusion Criteria:\n\n* Pregnancy or lactation\n* Cardiopulmonary-cerebral resuscitation (CPCR) performed during the current hospital admission\n* Pre-existing primary central nervous system (CNS) diseases, including:\n\nAcute cerebrovascular disease (e.g., hemiplegia, cranial nerve palsy) Central nervous system infection (e.g., pleocytosis in cerebrospinal fluid) Organic or metabolic encephalopathy (e.g., hepatic, renal, pulmonary, pancreatic, or severe inherited metabolic disorders) Drug-related encephalopathy (e.g., antipsychotic-associated encephalopathy, serotonin syndrome, neurotoxic antibiotics) Other structural or immunological brain diseases (e.g., traumatic brain injury, intracranial neoplasm, autoimmune encephalopathy)\n\n\\- Inability to cooperate with or tolerate scalp EEG electrode placement (e.g., extensive scalp trauma or open scalp infection)","90 Years",{"count":368,"type":22},78,"To characterize the electroencephalogram (EEG) features of sepsis patients with distinct inflammatory response phenotypes, dynamically track their evolutionary trajectories, and analyze their associations with long-term changes in cognitive function.",[28,371,372,373],"Sepsis Associated Encephalopathy","Sepsis and Septic Shock","Sepsis at Intensive Care Unit",[28,375,376,377,378],"Sepsis-Associated Encephalopathy","Electroencephalogram","Inflammatory Phenotype","Cognitive Dysfunction","2026-08-08",{"date":271,"type":36},{"date":382,"type":22},"2026-08-01",{"date":384,"type":22},"2027-05-01",{"name":386,"class":43},"Xiangya Hospital of Central South University",{"id":388,"slug":389,"hasResults":12,"nctId":390,"briefTitle":391,"officialTitle":392,"acronym":4,"eligibilityCriteria":393,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":394,"targetDuration":4,"studyType":23,"phases":396,"briefSummary":397,"conditions":398,"keywords":400,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":401,"lastUpdatePostDateStruct":402,"startDateStruct":403,"completionDateStruct":405,"leadSponsor":406,"locationsCount":4},"100651038","personalized-nutritional-formula-for-icu-patients-a-study-on-prognosis-and-multidimensional-health-markers-100651038","NCT07755033","Personalized Nutritional Formula for ICU Patients: A Study on Prognosis and Multidimensional Health Markers","The Effect of an Individualized Nutrition Formula on Clinical Prognosis, Intestinal and Pulmonary Microbiota, Serum Metabolomics, and Macronutrient Balance in Critically Ill Patients: A Prospective Interventional Study","Inclusion Criteria:\n\nCritically ill patients admitted to the intensive care unit (ICU) who meet the indications for enteral nutrition support.\n\nAge ≥ 18 years. APACHE II score \\> 8 at ICU admission. Expected ICU length of stay \\> 7 days.\n\nExclusion Criteria:\n\nAge \\\u003C 18 years. Pregnancy or lactation. Known allergy to any component of the enteral nutrition formula. Gastrointestinal bleeding, incomplete intestinal obstruction, or other conditions precluding full enteral nutrition.\n\nKnown severe thyroid dysfunction (e.g., thyrotoxic crisis, myxedema coma, or uncontrolled hyperthyroidism\u002Fhypothyroidism).\n\nChronic end-stage organ failure, including: New York Heart Association (NYHA) Class IV heart failure, Child-Pugh Class C cirrhosis, or Stage 5 chronic kidney disease (CKD).\n\nPrimary intestinal diseases (e.g., Crohn's disease, ulcerative colitis, or intestinal malignancies), short bowel syndrome, or history of extensive small bowel resection (residual small intestine \\\u003C 100 cm).\n\nMetabolic disorders that significantly affect nutritional metabolism (e.g., Sheehan's syndrome, or other conditions with major metabolic consequences) as determined by the investigator.",{"count":395,"type":22},1200,[25],"This study aims to evaluate the effects of an individualized enteral nutrition formula on clinical outcomes in critically ill adult patients in the intensive care unit (ICU). Participants will be randomly assigned to one of two groups: the individualized nutrition group or the standard nutrition group. In the individualized group, the total daily amount of enteral nutrition will be calculated and adjusted daily based on the patient's resting energy expenditure (measured by indirect calorimetry) and serum protein levels. In the standard group, a fixed-dose formula will be administered according to routine clinical protocols recommended by current guidelines. The intervention will be initiated within 48 hours of ICU admission and continued for up to 14 days or until ICU discharge. The study will assess clinical prognosis, as well as changes in gut and pulmonary microbiota, serum metabolomics, and macronutrient balance. The findings may provide evidence for personalized nutrition strategies in critically ill patients.",[28,236,399],"Gut -Microbiota",[89],"2026-08-05",{"date":323,"type":36},{"date":404,"type":22},"2026-07-28",{"date":157,"type":22},{"name":407,"class":408},"Chinese Medical Association","NETWORK",{"id":410,"slug":411,"hasResults":12,"nctId":412,"briefTitle":413,"officialTitle":414,"acronym":415,"eligibilityCriteria":416,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":19,"enrollmentInfo":417,"targetDuration":419,"studyType":116,"phases":4,"briefSummary":420,"conditions":421,"keywords":422,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":426,"lastUpdatePostDateStruct":427,"startDateStruct":429,"completionDateStruct":431,"leadSponsor":433,"locationsCount":436},"100623519","early-sepsis-recognition-tool-100623519","NCT07397689","Early Sepsis Recognition Tool","Sepsis Optimal Recognition Toolkit in Children (SORT): An Early Recognition Tool for Children in Asia","SORT","Inclusion Criteria:\n\n* Children \\\u003C 18 years old\n* Suspected infection defined by (1) blood culture performed (irrespective of result), AND (2) use of broad-spectrum anti-microbial agents, in the first 24 hours of admission\n\nExclusion Criteria:\n\n* 18 years and older\n* Patients who discharge At Own Risk (AOR) without outcome data",{"count":418,"type":22},40000,"30 Days","This study seeks to develop early recognition tools specially designed for children meeting the Phoenix definition and explore implementation science aspects by investigating facilitators and barriers to adopting Phoenix sepsis criteria in clinical practice. This addresses the critical need for systemic, evidence-based approaches to paediatric sepsis identification across diverse healthcare settings in Asia.",[142,28],[423,424,145,425],"Phoenix sepsis score","early recognition","child","2026-08-04",{"date":428,"type":36},"2026-08-07",{"date":430,"type":36},"2026-02-01",{"date":432,"type":22},"2028-12",{"name":434,"class":435},"KK Women's and Children's Hospital","OTHER_GOV",19,{"id":438,"slug":439,"hasResults":12,"nctId":440,"briefTitle":441,"officialTitle":441,"acronym":442,"eligibilityCriteria":443,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":52,"enrollmentInfo":444,"targetDuration":4,"studyType":23,"phases":445,"briefSummary":446,"conditions":447,"keywords":448,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":454,"lastUpdatePostDateStruct":455,"startDateStruct":456,"completionDateStruct":458,"leadSponsor":460,"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.",{"count":197,"type":22},[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],[28,449,450,451,452,453],"Delirium","Post intensive care syndrome","Biomarkers","NSE","NFL","2026-08-03",{"date":426,"type":36},{"date":457,"type":22},"2026-09",{"date":459,"type":22},"2028-08",{"name":461,"class":43},"Assistance Publique - Hôpitaux de Paris",{"id":463,"slug":464,"hasResults":12,"nctId":465,"briefTitle":466,"officialTitle":467,"acronym":468,"eligibilityCriteria":469,"healthyVolunteers":12,"sex":18,"minAge":222,"maxAge":19,"enrollmentInfo":470,"targetDuration":4,"studyType":116,"phases":4,"briefSummary":472,"conditions":473,"keywords":478,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":454,"lastUpdatePostDateStruct":485,"startDateStruct":486,"completionDateStruct":487,"leadSponsor":489,"locationsCount":491},"100649703","triage-performance-and-physiological-predictors-of-serious-illness-in-febrile-children-in-the-pediatric-emergency-department-100649703","NCT07739004","Triage Performance and Physiological Predictors of Serious Illness in Febrile Children in the Pediatric Emergency Department","Triage Performance and Physiological Parameters Predicting Serious Illness in Children Presenting With Fever to the Pediatric Emergency Department: A Multicenter Prospective Cohort Study","PEDTRIAGE","Inclusion Criteria:\n\n* Age 0-18 years\n* Presentation to the pediatric emergency department\n* Fever \\>=38.0 C at triage OR history of fever within the preceding 24 hours\n\nExclusion Criteria:\n\n* Presentation due to trauma\n* Elective visits\n* Missing triage data\n* Re-attendance within 72 hours for the same episode (only the first visit is included)",{"count":471,"type":22},3000,"This multicenter prospective observational cohort study evaluates how well the initial triage category assigned by the Turkish Ministry of Health three-level color-coded triage system (Red-Yellow-Green) predicts serious clinical outcomes in children aged 0-18 years who present with fever to pediatric emergency departments. The study additionally assesses whether physiological parameters recorded at triage (heart rate, respiratory rate, oxygen saturation, capillary refill time, AVPU level of consciousness, and general appearance) provide independent and incremental prognostic value beyond the assigned triage category. Ten centers across Turkey will enroll consecutive eligible febrile children over a 3-month period. Routine clinical care and triage decisions are not altered by the study. The primary outcome is a composite serious clinical outcome. The study is reported in accordance with the STROBE and TRIPOD statements.",[474,475,476,477,28],"Fever","Triage","Pediatric Emergency Medicine","Serious Bacterial Infection",[479,480,481,482,483,484],"pediatric triage","febrile children","clinical prediction model","emergency department","physiological parameters","undertriage",{"date":401,"type":36},{"date":404,"type":36},{"date":488,"type":22},"2026-12-01",{"name":490,"class":43},"TC Erciyes University",10,{"id":493,"slug":494,"hasResults":12,"nctId":495,"briefTitle":496,"officialTitle":496,"acronym":4,"eligibilityCriteria":497,"healthyVolunteers":112,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":498,"targetDuration":4,"studyType":116,"phases":4,"briefSummary":500,"conditions":501,"keywords":4,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":454,"lastUpdatePostDateStruct":502,"startDateStruct":503,"completionDateStruct":504,"leadSponsor":506,"locationsCount":4},"100647701","development-of-context-adapted-quality-indicators-for-early-sepsis-care-in-sub-saharan-africa---a-modified-delphi-consensus-procedure-100647701","NCT07711535","Development of Context-Adapted Quality Indicators for Early Sepsis Care in Sub-Saharan Africa - A Modified Delphi Consensus Procedure","Inclusion Criteria:\n\n* Professionals with proven experience in sepsis care or sepsis research in low- and middle-income countries, particularly Sub-Saharan Africa including physicians, nurses, researchers, and other healthcare professionals involved in early acute care and quality assurance\n* Minimum age of 18\n* Willingness to voluntarily participate in one or more Delphi rounds\n\nExclusion criteria:\n\n* Lack of professional expertise in the field of sepsis care\n* Refusal to consent to participation\n* Withdrawal from participation at the participant's own request",{"count":499,"type":22},45,"The research project is an anonymous, prospective, non-interventional consensus study in the form of a modified Delphi method, consisting of three online surveys and structured feedback meetings without recording. The goal is the structured evaluation and consolidation of expert assessments to develop context-adapted quality indicators and operationalize them for early sepsis care in Sub-Saharan Africa.",[28],{"date":401,"type":36},{"date":38,"type":22},{"date":505,"type":22},"2026-10",{"name":507,"class":43},"Charite University, Berlin, Germany",{"id":509,"slug":510,"hasResults":12,"nctId":511,"briefTitle":512,"officialTitle":512,"acronym":4,"eligibilityCriteria":513,"healthyVolunteers":112,"sex":18,"minAge":19,"maxAge":514,"enrollmentInfo":515,"targetDuration":4,"studyType":116,"phases":4,"briefSummary":516,"conditions":517,"keywords":519,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":454,"lastUpdatePostDateStruct":523,"startDateStruct":524,"completionDateStruct":526,"leadSponsor":528,"locationsCount":44},"100506542","correlation-of-memory-cd8-t-cells-with-sepsis-severity-and-mortality-a-single-center-unblinded-prospective-non-interventional-observational-study-100506542","NCT05875740","Correlation of Memory CD8+ T Cells With Sepsis Severity and Mortality: a Single-center, Unblinded, Prospective, Non-interventional, Observational Study","Inclusion Criteria:\n\nPatients aged 18-60 years old without restriction of gender, race, religion, creed or nationality; No sedative drugs with elimination half-life were used before inclusion in the study; Patients and\u002For their family members know and agree to participate in the trial.\n\nExclusion Criteria:\n\nHistory of solid organ or bone marrow transplantation; Diseases that may affect immune-related indicators, such as autoimmune diseases such as rheumatoid arthritis and SLE, or hematological malignancies such as leukemia and lymphoma; Have received radiotherapy or chemotherapy within the past 30 days, or have received immunosuppressive drugs (tripterygium, mycophenolate, cyclophosphamide, FK506, etc); Pregnancy or lactation; Chronic nephrosis; Severe chronic liver disease (child-Pugh: Grade C); alcohol or opioid dependence, mental illness, or severe cognitive impairment; Patients and\u002For their family members refuse to participate in the trial.","60 Years",{"count":261,"type":22},"Sepsis is defined as a life-threatening organ dysfunction that is caused by a dysregulated host response to infection. Severe sepsis is the most common cause of death among critically ill patients in non-coronary intensive care units (ICU). Sustained excessive inflammation and immune dysfunction have been confirmed to play a key role in organ damage and early death of sepsis patients. Therefore, it is important to reduce excessive inflammatory response mediated by immune cells and pro-inflammatory cytokines in the acute phase of sepsis.\n\nSingle-cell RNA sequencing performed on both septic patients and mice suggest that changes in Tcm (CD3+ CD8+ CD44+ CD127+ CD62L+) and Tem (CD3+ CD8+ CD44+ CD127+ CD62L -) in the acute phase of sepsis may play an important role in sepsis. In addition, animal researches showed that Tcm and Tem decreased decreased continuously at 24, 48 and 72h after cecal ligation and perforation (CLP) in mice, and the adoptive transfer of Tcm , sorting from spleen of mice 24h after CLP , but not Tem improved 7-day survival rate of sepsis mice.\n\nThis observational study is aimed to investigate the quantity and proliferation of Tcm and Tem in the acute phase of sepsis and their correlation with severity level and mortality of septic patients in ICU.",[28,518],"Inflammatory Response",[243,520,521,522],"CD8+ T cell","central memory CD8+ T cell","inflammatory response",{"date":426,"type":36},{"date":525,"type":36},"2023-09-06",{"date":527,"type":22},"2026-09-30",{"name":529,"class":43},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology",{"id":531,"slug":532,"hasResults":12,"nctId":533,"briefTitle":534,"officialTitle":534,"acronym":4,"eligibilityCriteria":535,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":113,"enrollmentInfo":536,"targetDuration":4,"studyType":116,"phases":4,"briefSummary":538,"conditions":539,"keywords":541,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":543,"lastUpdatePostDateStruct":544,"startDateStruct":546,"completionDateStruct":548,"leadSponsor":550,"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",{"count":537,"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....",[28,29,540],"Sepsis-Associated Immune Dysregulation",[542],"SEPSIS","2026-07-29",{"date":545,"type":36},"2026-07-30",{"date":547,"type":22},"2027-01-01",{"date":549,"type":22},"2037-01-31",{"name":551,"class":552},"National Heart, Lung, and Blood Institute (NHLBI)","NIH",{"id":554,"slug":555,"hasResults":12,"nctId":556,"briefTitle":557,"officialTitle":558,"acronym":559,"eligibilityCriteria":560,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":52,"enrollmentInfo":561,"targetDuration":4,"studyType":23,"phases":563,"briefSummary":564,"conditions":565,"keywords":566,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":543,"lastUpdatePostDateStruct":567,"startDateStruct":568,"completionDateStruct":570,"leadSponsor":572,"locationsCount":574},"100609524","phase-2-a-study-to-investigate-the-efficacy-safety-and-tolerability-of-azd4144in-participants-with-sepsis-associated-acute-kidney-injury-100609524","NCT07215702","A Study to Investigate the Efficacy, Safety, and Tolerability of AZD4144in Participants With Sepsis-associated Acute Kidney Injury.","A Phase IIa, Randomised, Double-blind, Placebo-controlled, Multicentre Study to Assess the Efficacy, Safety, and Tolerability of AZD4144 in Participants With Sepsis-associated Acute Kidney Injury (SERENIA)","SERENIA","Inclusion Criteria Age ≥ 18 to ≤ 80 years at the time of signing the informed consent. Participants who are admitted to an ICU or an equivalent critical-care unit.\n\nDiagnosis of sepsis according to criteria defined by The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3) based on:\n\nA. Suspected or confirmed bacterial infection AND B. Acute increase of mSOFA score of 2 or more excluding renal component (change in score measured to account for participants that may meet mSOFA criteria from pre-existing organ dysfunction before the onset of infection).\n\nHaemodynamic therapy:\n\nA. 30 mL\u002Fkg or clinically appropriate volume resuscitation prior to randomisation.\n\nB. Vasopressor and\u002For inotrope therapy for sepsis-induced hypotension (eg, norepinephrine \\[noradrenaline\\], epinephrine \\[adrenaline\\], phenylephrine, dopamine, dobutamine) for ≥ 4 hours.\n\nDiagnosis of AKI, within 72 hours of sepsis diagnosis, with modified KDIGO Stage ≥ 1, defined as: Increase in SCr to ≥ 1.5 × baseline (outpatient \\[preferred\\] or admission pre-AKI reference). Timing of AKI diagnosis is defined as the time that the initial qualifying SCr was reported. AKI must persist after completion of initial volume resuscitation (30 mL\u002Fkg or as clinically indicated per investigator discretion).\n\nOutpatient pre-AKI reference eGFR ≥ 30 mL\u002Fmin\u002F1.73 m2, if available within 2 weeks to 12 months prior to admission (preferred). If not available, admission pre-AKI reference eGFR ≥ 45 mL\u002Fmin\u002F1.73 m2 .\n\nBody weight ≥ 40 kg or ≤ 125 kg. Female or male, assigned at birth, inclusive of all gender identities. All FOCBP must have a negative pregnancy test at the Screening visit (Visit 1).\n\nContraception:\n\nA. Sexually active fertile male participants with partners of childbearing potential must adhere to the contraception methods detailed in CSP from the time of first administration of study intervention administration until 100 days after the last dose of study intervention.\n\nB. FOCBP must not be lactating and must agree to use an approved method of highly effective contraception, as detailed in the CSP from the time of first administration of study intervention until 100 days after last dose of study intervention.\n\nCapable of giving signed informed consent (participant or LAR). Provision of signed and dated written Optional Genomics Initiative Research Information and Consent Form prior to collection of samples for optional genomics initiative research.\n\nExclusion Criteria Any clinical evidence which in the investigator's opinion makes it undesirable for the potential participant to enrol in the study.\n\nKnown history of Stage 4 or 5 CKD with documented sustained eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m2 prior to hospital admission.\n\nSepsis diagnosed \\> 7 days after hospital admission (to include from time of outside admission if patient transferred from another healthcare setting).\n\nAKI attributed to causes other than sepsis, including but not limited to compromised renal perfusion-related causes (surgical complication, acute abdominal aortic aneurysm, dissection, renal artery stenosis, etc), glomerular disease, acute interstitial nephritis, and medication toxicity.\n\nEvidence of recovery from AKI prior to randomisation defined as:\n\nA. A reduction of SCr to less than 1.5 times reference SCr in the last available local SoC laboratory result before randomisation or B. A \\> 25% reduction in SCr from peak SCr after volume resuscitation prior to randomisation.\n\nExpected survival from sepsis \\\u003C 24 hours. Expected survival \\\u003C 90 days due to chronic or pre-existing medical conditions other than SA-AKI Known history of renal transplant or bilateral nephrectomy. Permanent incapacitation. Incapacitation is defined as the inability to independently perform tasks essential to personal health and\u002For safety.\n\nActive cancer or cancer in remission for less than 2 years. Known history of immunodeficiency disease or currently receiving immunosuppressant therapy for non-sepsis related disease.\n\nSevere burns requiring ICU treatment. Sepsis attributed to confirmed or presumed fungal or viral infection at time of Screening.\n\nHas advanced chronic liver disease, confirmed by a Child-Pugh score of 10-15 (Class C).\n\nKnown history of cerebrovascular accident within the last 90 days. Known history of heart failure with reduced ejection fraction with documented ejection fraction ≤ 20% before sepsis diagnosis.\n\nKnown hypersensitivity to iohexol or known history of severe adverse reaction to iodinated contrast media.\n\nParticipants with known medical or psychological condition(s), or who, in the judgement of the investigator, should not participate in the study if they are unlikely to comply with study procedures, restrictions, and requirements.\n\nCurrent KRT (eg, continuous haemofiltration and haemodialysis\u002Fcontinuous kidney replacement therapy, intermittent haemodialysis, and peritoneal dialysis) or planned KRT (meaning KRT is scheduled, or the decision to initiate KRT has been made by the treating physician) at randomisation.\n\nCurrently receiving active treatment for malignancy.\n\nPotential participants will be excluded if they have received a certain class of medication during the weeks before enrollment or are anticipated to require a specific class of medication during the trial duration.\n\nParticipants with a known hypersensitivity to AZD4144 or any of the excipients of the product.\n\nReceipt of another IMP within 30 days, 5 half-lives, or the time frame of expected PD effect from most recent dose, whichever is longest.\n\nPrevious receipt of AZD4144. Active or planned treatment of sepsis with an extracorporeal haemoperfusion device.\n\nParticipation in any other concurrent ICU study which could impact participant clinical outcomes and confound results of this study to, including but not limited to volume resuscitation, vasopressor, or mechanical ventilation studies.\n\nPresence of anuria (≥ 12 hours) at randomisation. Any clinically important abnormalities in rhythm, conduction, or morphology of the resting 12-lead ECG, at Screening, as judged by the investigator.\n\nProlonged QTcF \\> 470 ms. Known history of QT prolongation associated with other medications that required discontinuation of that medication.\n\nCongenital long QT syndrome. Known history of ST-elevation myocardial infarction or non-ST-elevation myocardial infarction, with or without intervention by percutaneous coronary intervention or coronary artery bypass grafting within the last 90 days.\n\nVentricular arrhythmia requiring treatment. Known or presumed latent or active tuberculosis. Acute pancreatitis with no established source of infection. Undergoing extracorporeal membrane oxygenation (ECMO) at randomisation. Neutropenia: ANC \\\u003C 1.5 × 109\u002FL. Admitting diagnosis of rhabdomyolysis. Admitting diagnosis of trauma with CK \\> 15000 U\u002FL. Presumed nidus of infection in central nervous system. Involvement in the planning and\u002For conduct of the study (applies to both AstraZeneca staff and\u002For staff at the study site).\n\nPrevious randomisation in the present study. For females only - currently pregnant (confirmed with positive pregnancy test) or breast-feeding.\n\nFirst infusion of IMP unable to be started within 36 hours of AKI diagnosis. Presence of a do-not-resuscitate order.",{"count":562,"type":22},124,[227],"This study will enroll adults aged 18 to 80 years diagnosed with sepsis due to a suspected or confirmed bacterial infection, within 7 days of being admitted to the hospital, and who have also developed acute kidney injury within 72 hours of the onset of sepsis. Eligible participants will be randomly assigned to receive either AZD4144 or a placebo intravenously once daily for the number of days specified in the CSP. During this Treatment Period, participants will undergo daily safety monitoring, as well as blood and urine sample collection and other assessments. After the Treatment Period, participants will continue to be monitored for safety and other assessments during each additional day they remain hospitalized (if applicable) as well as during up to 2 follow up visits after discharge. The main goal is to compare specific kidney function measurements between those participants receiving AZD4144 and those receiving the placebo.",[28,143],[28,143],{"date":545,"type":36},{"date":569,"type":36},"2026-02-10",{"date":571,"type":22},"2027-02-11",{"name":573,"class":72},"AstraZeneca",72,{"id":576,"slug":577,"hasResults":12,"nctId":578,"briefTitle":579,"officialTitle":580,"acronym":581,"eligibilityCriteria":582,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":583,"targetDuration":584,"studyType":116,"phases":4,"briefSummary":585,"conditions":586,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":404,"lastUpdatePostDateStruct":587,"startDateStruct":589,"completionDateStruct":591,"leadSponsor":593,"locationsCount":331},"100649772","peripheral-perfusion-index-trajectory-to-predict-28-day-mortality-in-patients-with-sepsis-in-the-intensive-care-unit-100649772","NCT07740304","Peripheral Perfusion Index Trajectory to Predict 28-Day Mortality in Patients With Sepsis in the Intensive Care Unit","Peripheral Perfusion Index Trajectory as a Predictor of 28-Day Mortality and Its Incremental Value Over SOFA and Lactate in Patients With Sepsis and Septic Shock: A Prospective Observational Cohort Study","PERFUSE-ICU","Inclusion Criteria:\n\n* Age 18 years or older\n* Diagnosis of sepsis or septic shock according to Sepsis-3 criteria (suspected or confirmed infection with an acute increase in SOFA score of 2 points or more)\n* Enrollment possible within the first 6 hours of intensive care unit admission\n* Written informed consent obtained from the patient or, when the patient lacks decision-making capacity, from a legal representative, in accordance with the approved consent procedure\n\nExclusion Criteria:\n\n* Conditions precluding valid peripheral perfusion measurement at both measurement sites, including severe peripheral arterial disease, limb ischemia or amputation, extensive edema or burns, or local trauma at the measurement site\n* Intensive care unit stay of 24 hours or longer at another facility prior to admission\n* Decision to withdraw or limit life-sustaining treatment planned within the first 24 hours\n* Pregnancy\n* Severe Raynaud phenomenon or vasospastic disease of the extremities\n* Persistent tremor or agitation precluding standardized measurement\n* Concurrent enrollment in an interventional study",{"count":287,"type":22},"90 Days","Sepsis is a life-threatening condition caused by the body's overwhelming response to infection, and it remains a leading cause of death in intensive care units. Even when standard treatment targets such as blood pressure are met, blood flow to the small vessels of the skin and other tissues may remain impaired. This \"hidden\" poor perfusion may not be detected by routine monitoring, yet it may be linked to worse outcomes.\n\nThe perfusion index is a simple number obtained from the standard pulse oximeter already placed on a patient's finger. It reflects blood flow in the peripheral tissues, requires no additional procedure, and causes no discomfort.\n\nThis prospective observational cohort study will examine whether the perfusion index, and especially how it changes over the first 24 hours in the intensive care unit, can help predict death within 28 days in adults with sepsis or septic shock. Capillary refill time and skin mottling score will be recorded as additional bedside measures of peripheral perfusion.\n\nNo treatment will be changed for the purpose of this study, and no additional blood samples or invasive procedures will be performed. All care decisions remain with the treating team. Measurements will be taken at intensive care admission and at 6 and 24 hours. Participants will be followed for 28 days, with survival status also recorded at 90 days.\n\nThe study will be conducted at two centers. A prediction model will be developed in the first center and then tested, without modification, in patients enrolled at the second center.",[28,89],{"date":588,"type":36},"2026-07-31",{"date":590,"type":36},"2026-07-06",{"date":592,"type":22},"2027-10-07",{"name":594,"class":43},"Trakya University",{"id":596,"slug":597,"hasResults":12,"nctId":598,"briefTitle":599,"officialTitle":599,"acronym":4,"eligibilityCriteria":600,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":601,"targetDuration":4,"studyType":116,"phases":4,"briefSummary":603,"conditions":604,"keywords":4,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":404,"lastUpdatePostDateStruct":605,"startDateStruct":606,"completionDateStruct":607,"leadSponsor":609,"locationsCount":4},"100649760","relation-of-serum-phosphate-level-to-the-duration-of-mechanical-ventilation-in-patient-with-sepsis-100649760","NCT07739251","Relation of Serum Phosphate Level to the Duration of Mechanical Ventilation in Patient With Sepsis","Inclusion Criteria:\n\n* Patients with sepsis or meeting the diagnostic criteria of septic shock\n* Clinical criteria of septic shock\n* A patient with sepsis who, despite adequate fluid resuscitation, has:\n* A vasopressor requirement to maintain a mean arterial pressure (MAP) ≥ 65 mmHg, and\n* A serum lactate level \\> 2 mmol\u002FL (18 mg\u002FdL)\n* Age more than 18 years old\n\nExclusion Criteria:\n\n* \\- Age less than 18 years.\n* ICU stay less than 24 hours.\n* Patients receiving renal replacement therapy before ICU admission.\n* Patients with known parathyroid disorders or metabolic bone disease.\n* Patients receiving phosphate supplements before ICU admission.\n* Patients receiving medications affecting phosphate levels, such as , insulin overdose, or chemotherapy.\n* Patients with diabetic ketoacidosis.\n* Patients with burns, major trauma, or postoperative ICU admission.\n* Pregnant patients.\n* Refusal to participate in the study.",{"count":602,"type":22},110,"Sepsis is a life-threatening organ dysfunction caused by a dysregulated host response to infection.\n\nSeptic shock is a subset of sepsis in which underlying circulatory and cellular\u002Fmetabolic abnormalities are profound enough to substantially increase mortality.\n\nSeptic shock represents the most severe form of sepsis and remains a leading cause of admission to intensive care units (ICUs) worldwide. It is characterized by profound circulatory, cellular, and metabolic abnormalities resulting from a dysregulated host response to infection .\n\nDespite significant advances in antimicrobial therapy, haemodynamic monitoring, organ support, and critical care management, septic shock continues to be associated with high morbidity and mortality. Patients frequently develop multiple organ dysfunction requiring prolonged ICU stay, mechanical ventilation, vasopressors support, and renal replacement therapy .\n\nIdentification of modifiable risk factors that influence clinical outcomes remains a major priority in the management of septic shock. Electrolyte disturbances are common among critically ill patients, with hypophosphatemia being one of the most frequently encountered abnormalities .\n\nSerum phosphate plays a vital role in numerous physiological processes, including cellular energy production, adenosine triphosphate (ATP) synthesis, oxygen delivery through regulation of 2,3-diphosphoglycerate, membrane integrity, intracellular signaling, acid-base balance, and neuromuscular function .\n\nIn septic shock, hypophosphatemia may develop because of intracellular phosphate redistribution induced by catecholamine release, respiratory alkalosis, insulin administration, aggressive fluid resuscitation, renal phosphate wasting, malnutrition, and continuous renal replacement therapy. Consequently, phosphate depletion may occur early during the course of critical illness and may persist despite standard supportive treatment .\n\nHypophosphatemia has important clinical implications in critically ill patients. Severe phosphate deficiency impairs diaphragmatic contractility, respiratory muscle strength, myocardial performance, leukocyte function, and skeletal muscle metabolism. These abnormalities may delay liberation from mechanical ventilation, impair oxygen delivery, increase susceptibility to infection, prolong ICU stay, and adversely affect patient outcomes .\n\nSeveral studies have suggested that hypophosphatemia is associated with increased disease severity, prolonged mechanical ventilation, and higher mortality in critically ill patients, although the available evidence remains inconsistent, particularly among patients with septic shock.\n\nMechanical ventilation is frequently required in septic shock because of respiratory failure, acute respiratory distress syndrome, impaired consciousness, or hemodynamic instability. Successful weaning from mechanical ventilation depends largely on adequate respiratory muscle function and sufficient cellular energy production, both of which require normal phosphate homeostasis .\n\nHypophosphatemia may reduce diaphragmatic strength and impair respiratory muscle endurance, resulting in prolonged ventilator dependence and delayed weaning. Therefore, early recognition and correction of phosphate deficiency may represent a potentially modifiable factor capable of improving respiratory outcomes in critically ill patients .\n\nAlthough phosphate disturbances are well recognized in the ICU, data regarding the incidence of hypophosphatemia upon ICU admission and its relationship with the duration of mechanical ventilation in patients with septic shock remain limited, particularly in developing countries. Understanding this relationship may facilitate early identification of high-risk patients, optimize electrolyte management, improve ventilator weaning strategies, and ultimately reduce ICU morbidity and healthcare costs .",[28],{"date":588,"type":36},{"date":457,"type":22},{"date":608,"type":22},"2027-10",{"name":610,"class":43},"Assiut University",{"id":612,"slug":613,"hasResults":12,"nctId":614,"briefTitle":615,"officialTitle":615,"acronym":616,"eligibilityCriteria":617,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":618,"targetDuration":4,"studyType":23,"phases":619,"briefSummary":620,"conditions":621,"keywords":622,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":404,"lastUpdatePostDateStruct":631,"startDateStruct":632,"completionDateStruct":634,"leadSponsor":636,"locationsCount":44},"100649448","validation-of-a-capillary-leak-index-during-septic-shock-based-on-haemoglobin-level-variations-induced-by-fluid-resuscitation-a-pilot-study-100649448","NCT07733206","Validation of a Capillary Leak Index During Septic Shock, Based on Haemoglobin Level Variations Induced by Fluid Resuscitation. A Pilot Study.","IFC-sepsis","Inclusion Criteria:\n\n* Test group (septic shock patients):\n* Adults admitted to the general ICU within 24 hours with a diagnosis of septic shock\n* Eligible for blood sampling during daytime hours\n\nControl group (non septic shock patients):\n\n* Adults admitted to the postoperative ICU within 24 hours after surgery\n* Need for fluid resuscitation\n* Eligible for blood sampling during daytime hours\n* Patients with an arterial catheter in place as part of their care\n\nExclusion Criteria:\n\n* \\- Clarkson's disease (idiopathic capillary leak syndrome)\n* Pre-existing extracellular fluid overload (e.g., cirrhosis, decompensated heart failure, nephrotic syndrome, chronic kidney disease on or awaiting dialysis)\n* Active bleeding or hemolysis\n* Receiving ECMO\n* Ongoing renal replacement therapy during the intervention\n* Blood transfusion within one hour before the intervention\n* Change in vasopressor or inotrope dose within 30 minutes before the intervention",{"count":170,"type":22},[25],"This study aims to validate a simple and reproducible index of capillary leak (CLI) in septic shock, based on haemoglobin (Hb) variation induced by standardised fluid resuscitation. To achieve this, the correlation between CLI and biomarkers of endothelial dysfunction-angiopoietin-2 and syndecan-1-will be assessed in both septic and non-septic shock patients. CLI may contribute to the individualisation of fluid management in patients with septic shock.",[28],[95,623,624,625,626,627,628,629,630],"capillary leak","endothelial dysfunction","angiopoietin-2","syndecan-1","fluid resuscitation","haemoglobin variation","extracellular water","bio-impedance",{"date":543,"type":36},{"date":633,"type":22},"2026-09-15",{"date":635,"type":22},"2028-10-15",{"name":637,"class":43},"University Hospital Center of Martinique",{"id":639,"slug":640,"hasResults":12,"nctId":641,"briefTitle":642,"officialTitle":643,"acronym":644,"eligibilityCriteria":645,"healthyVolunteers":112,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":646,"targetDuration":4,"studyType":116,"phases":4,"briefSummary":648,"conditions":649,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":404,"lastUpdatePostDateStruct":654,"startDateStruct":655,"completionDateStruct":657,"leadSponsor":659,"locationsCount":44},"100649363","microbiome-and-enteric-signatures-in-sepsis-associated-hepatorenal-injury-100649363","NCT07735182","Microbiome and Enteric Signatures in Sepsis-associated Hepatorenal Injury","The Impact of Gut Microbiota on Sepsis-Associated Acute Hepatorenal Injury: A Prospective, Multicenter, Observational Study","MESH","Inclusion Criteria:\n\n\\-\n\nFor Sepsis Patients:\n\n1. Age ≥ 18 years；\n2. Admitted to the Intensive Care Unit (ICU) and meets the Sepsis-3 diagnostic criteria (an acute change in total Sequential Organ Failure Assessment \\[SOFA\\] score ≥ 2 points consequent to the infection).\n3. Diagnosed with sepsis within 24 hours prior to enrollment.\n4. Informed consent signed by the patient or a legally authorized representative.\n\nFor Healthy Volunteers:\n\n1. Age ≥ 18 years.\n2. No chronic underlying diseases (including liver, kidney, gastrointestinal, or immune-related disorders).\n3. No use of antibiotics or probiotics, and no history of acute infection within 1 month prior to enrollment (to ensure baseline consistency).\n4. Informed consent signed by the volunteer.\n\nExclusion Criteria:\n\n1. History of chronic liver disease (e.g., cirrhosis, chronic hepatitis B\u002FC, autoimmune hepatitis, hepatic carcinoma).\n2. History of chronic kidney disease (e.g., glomerulonephritis, IgA nephropathy).\n3. History of inflammatory bowel disease (including ulcerative colitis and Crohn's disease) or previous major intestinal resection.\n4. Patients with malignant tumors currently receiving chemotherapy or radiotherapy.\n5. Expected survival time of less than 72 hours.\n6. Pregnant or lactating women.\n7. Concurrent participation in other interventional clinical trials.",{"count":647,"type":22},200,"Sepsis is a major cause of morbidity and mortality in intensive care units. Sepsis-associated liver injury (SALI) and sepsis-associated acute kidney injury (S-AKI) are common complications associated with adverse clinical outcomes. Altered gut microbial diversity, microbial metabolites, intestinal barrier dysfunction, and systemic inflammation may contribute to hepato-renal injury during sepsis; however, prospective longitudinal evidence in patients with SALI and S-AKI remains limited.\n\nThis prospective, multicenter, longitudinal observational cohort study will enroll adult patients with sepsis across five medical centers and healthy adult volunteers as a baseline reference cohort. For patients with sepsis, stool and blood samples will be collected on Day 0, Days 3-5, Days 7-10, and Days 14-20 after sepsis diagnosis. Healthy volunteers will provide a single baseline stool and blood sample at enrollment. Fecal microbial alpha diversity and community structure will be assessed by metagenomic sequencing and bioinformatic analysis. Plasma metabolites, including total short-chain fatty acids, indoxyl sulfate, and additional targeted plasma metabolites, will be measured by ultra-high-performance liquid chromatography-tandem mass spectrometry. Intestinal barrier and clinical biomarkers will also be assessed.\n\nThe primary objectives are to evaluate the associations between baseline fecal microbial alpha diversity, measured by the Shannon diversity index, and SALI and S-AKI occurring within 7 days after sepsis diagnosis. Secondary objectives include evaluating the associations of baseline fecal microbial beta diversity with SALI and with S-AKI occurring within 7 days after sepsis diagnosis, characterizing longitudinal changes in fecal microbial alpha diversity, measuring plasma metabolite and intestinal biomarker concentrations at prespecified time points, and assessing 28-day all-cause mortality. Exploratory multi-omics analyses will evaluate Proteobacteria and additional microbial taxa, microbial functional genes, metabolites, and host biomarkers. This study aims to identify candidate biomarkers and biological pathways relevant to hepato-renal injury in sepsis.",[28,650,651,652,653],"Acute Kidney Injury Due to Sepsis","Gastrointestinal Microbiome","Sepsis-Associated Liver Injury","Intensive Care Medicine",{"date":543,"type":36},{"date":656,"type":36},"2026-02-15",{"date":658,"type":22},"2028-02-14",{"name":660,"class":43},"First Affiliated Hospital of Zhejiang University"]