[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"acute-kidney-injury-due-to-sepsis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:acute-kidney-injury-due-to-sepsis":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,44,77,106],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100649363","microbiome-and-enteric-signatures-in-sepsis-associated-hepatorenal-injury-100649363",false,"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.",true,"ALL","18 Years",{"count":21,"type":22},200,"ESTIMATED","OBSERVATIONAL","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.",[26,27,28,29,30],"Sepsis","Acute Kidney Injury Due to Sepsis","Gastrointestinal Microbiome","Sepsis-Associated Liver Injury","Intensive Care Medicine","RECRUITING","2026-07-28",{"date":34,"type":35},"2026-07-29","ACTUAL",{"date":37,"type":35},"2026-02-15",{"date":39,"type":22},"2028-02-14",{"name":41,"class":42},"First Affiliated Hospital of Zhejiang University","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":18,"minAge":4,"maxAge":52,"enrollmentInfo":53,"targetDuration":55,"studyType":23,"phases":4,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":76},"100555878","quelimmune-scd-ped-pediatric-surveillance-registry-100555878","NCT06517810","QUELIMMUNE (SCD-PED) PediAtric SurVeillance REgistry","Pediatric Selective Cytopheretic Device (SCD-PED, QUELIMMUNE) for Critically Ill Children With Acute Kidney Injury: A Humanitarian Device Exemption (HDE) Surveillance Registry Protocol","SAVE","Inclusion Criteria:\n\n* All patients initiated on QUELIMMUNE therapy under the HDE-approved indication\n\nExclusion Criteria:\n\n* Weight \\\u003C10kg\n* Age \\>22 years\n* Known allergy to any components of QUELIMMUNE","22 Years",{"count":54,"type":22},50,"90 Days","QUELIMMUNE is FDA-approved under an HDE for the treatment of pediatric patients (weight ≥10kg and age ≤22 years) with AKI due to sepsis or a septic condition on antibiotic therapy and requiring RRT.\n\nThe purpose of this surveillance registry is to prospectively collect safety data among all patients treated with QUELIMMUNE under the HDE. More specifically, we intend on comparing the incidence of new (secondary) blood stream infections in the first 28 days after SCD-PED initiation to a comparator group of matched CKRT patients with sepsis who did not receive treatment with QUELIMMUNE",[58,27],"Acute Kidney Injury",[60,61,62,63,64,65],"continuous kidney replacement therapy","continuous renal replacement therapy","acute kidney injury","organ failure","inflammation","dialysis","2026-05-11",{"date":68,"type":35},"2026-05-14",{"date":70,"type":35},"2024-07-19",{"date":72,"type":22},"2026-08",{"name":74,"class":75},"SeaStar Medical","INDUSTRY",15,{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":91,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":43},"100629932","hemodynamic-resuscitation-guided-by-non-invasive-mean-systemic-filling-pressure-to-prevent-acute-kidney-injury-in-septic-shock-100629932","NCT07481097","Hemodynamic Resuscitation Guided by Non-Invasive Mean Systemic Filling Pressure to Prevent Acute Kidney Injury in Septic Shock","Hemodynamic Resuscitation Guided by Non-Invasive Mean Systemic Filling Pressure to Prevent Acute Kidney Injury in Septic Shock: A Randomized Controlled Trial Integrating Renal Doppler Indices","Inclusion Criteria:\n\n* Adult patients (Age 18 years or older) admitted to the Intensive Care Unit.\n* Primary diagnosis of Septic Shock defined according to the Third International Consensus Definitions for Sepsis (Sepsis-3): Sepsis with persisting hypotension requiring vasopressors to maintain MAP 65 mmHg or greater and having a serum lactate level greater than 2 mmol\u002FL despite adequate volume resuscitation.\n* Patients must be mechanically ventilated and sedated to ensure baseline hemodynamic stability.\n* Presence of an invasive arterial catheter and a central venous catheter.\n\nExclusion Criteria:\n\n* Known pre-existing chronic kidney disease (CKD Stage 4 or 5) or patients on chronic renal replacement therapy.\n* Contraindications to arm cuff inflation, including upper limb trauma, -lymphedema, arteriovenous fistula, or peripheral vascular disease.\n* Severe valvular heart disease, specifically severe tricuspid regurgitation, which invalidates CVP interpretation.\n* Intra-abdominal hypertension (Intra-abdominal pressure greater than 15 mmHg) which mechanically alters venous return independent of blood volume.\n* Moribund patients with a predicted mortality within 24 hours.",{"count":85,"type":22},100,"INTERVENTIONAL",[88],"NA","The goal of this clinical trial is to evaluate the efficacy of a hemodynamic resuscitation protocol guided by the Venous Return Gradient (Pmsf - CVP), measured via the non-invasive arm cuff technique, in reducing the incidence of Acute Kidney Injury (AKI) in patients with septic shock compared to standard care and to assess the precision and reproducibility of the non-invasive arm cuff Pmsf measurement in the septic shock population and to determine the correlation between the systemic Venous Return Gradient and the renal micro-circulatory Resistance Index (RRI).",[27],[92,62,93,94,95],"sepsis","resuscitation","mean systemic filling pressure","renal resistive index","NOT_YET_RECRUITING","2026-03-15",{"date":99,"type":35},"2026-03-18",{"date":101,"type":22},"2026-04-01",{"date":103,"type":22},"2028-08",{"name":105,"class":42},"Assiut University",{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":116,"conditions":117,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":43},"100483437","hemodynamic-stability-in-septic-shock-patients-undergoing-continuous-renal-replacement-therapy-with-oxiris-membrane-100483437","NCT05575024","Hemodynamic Stability in Septic Shock Patients Undergoing Continuous Renal Replacement Therapy With oXiris Membrane","Real-time Monitoring of Hemodynamic Stability in Septic Shock Patients Undergoing Continuous Renal Replacement Therapy: Propensity Score-matched Comparison Between oXiris and Polysulfone Membranes","HISTORIX","Inclusion Criteria:\n\n* Aged ≥ 18 years\n* Sepsis related acute kidney injury requiring continuous renal replacement therapy\n\nExclusion Criteria:\n\n• No monitoring of blood pressure and ECG",{"count":115,"type":22},98,"The new adsorbing membrane for continuous renal replacement therapy (CRRT), oXiris, can reduce plasma cytokines and endotoxins in septic shock patients with severe acute kidney injury, compared with standard membranes. However, its hemodynamic stability or benefits have not been thoroughly evaluated although this is reasonable.",[27],"2025-05-12",{"date":120,"type":35},"2025-05-15",{"date":122,"type":35},"2024-01-01",{"date":124,"type":22},"2026-12-31",{"name":126,"class":42},"Seoul National University Hospital"]