[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100607154":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":32,"locations":31,"responsibleParty":38,"collaborators":31,"id":42,"slug":43,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":44,"sex":50,"minAge":51,"maxAge":31,"enrollmentInfo":52,"targetDuration":31,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":63,"whyStopped":31,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":31},{"fullName":5,"class":6},"Institute of Liver and Biliary Sciences, India","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard of Care (SOC)","ACTIVE_COMPARATOR","Participants in this arm will receive standard medical treatment for ACLF with septic shock and acute kidney injury, as per institutional protocols.",[13],"Other: Standard of Care (SOC)",{"label":15,"type":16,"description":17,"interventionNames":18},"Vitamin C + Standard of Care","EXPERIMENTAL","Participants in this arm will receive intravenous Vitamin C (25 mg\u002Fkg, up to 1.5 g every 6 hours for 5 days) in addition to standard medical treatment for ACLF with septic shock and acute kidney injury",[19],"Drug: Vitamin C",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Vitamin C","Intravenous Vitamin C, 25 mg\u002Fkg (maximum 1.5 g) every 6 hours for 5 days, administered in addition to standard medical treatment",[15],[27],"(Ascorbic Acid)",{"type":6,"name":9,"description":29,"armGroupLabels":30,"otherNames":31},"Supportive and guideline-based management of ACLF with septic shock and AKI, including antibiotics, fluids, vasopressors, renal replacement therapy as required, and other standard therapies",[9],null,[33],{"name":34,"role":35,"phone":36,"phoneExt":31,"email":37},"Dr. Rakhi Maiwall, MBBS, MD, DM","CONTACT","+91 8750343085","rakhi_2011@yahoo.co.in",{"type":39,"investigatorFullName":40,"investigatorTitle":41,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"PRINCIPAL_INVESTIGATOR","Rakhi Maiwall","Professor (hepatology)","100607154","vitamin-c-for-acute-kidney-injury-in-aclf-with-septic-shock-a-randomized-controlled-trial-100607154",false,"NCT07184866","Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial","A Randomized Controlled Trial Open Label Evaluating the Efficacy of Vitamin C in Improving Outcomes of Acute Kidney Injury in Patients With ACLF With Septic Shock","VITAKI-ACLF","Inclusion Criteria:\n\n* ACLF as per asia pacific association for the study of liver (APASL criteria) with AKI according to KDIGO Criteria and septic shock.\n\nExclusion Criteria:\n\n* • Refractory Septic shock with more than 3 organ failures.\n\n  * Patients with age less than 18 years\n  * Known severe cardiopulmonary disease (structural or valvular heart disease, coronary artery disease, COPD)\n  * Patients in DIC with platelets \\\u003C 20,000 and INR \\> 4 or active bleeding\n  * Limitations of care (defined as refusal of cardiovascular and respiratory support modes) including \"do not intubate\" (DNI) status\n  * Current hospitalization \\> 15 days for patients with nosocomial acquisition of MDR at time of randomization\n  * Known allergy or contraindication to vitamin C (including previously or currently diagnosed primary hyperoxaluria and\u002For oxalate nephropathy, or known\u002Fsuspected ethylene glycol ingestion,\n  * Known glucose-6-phosphate dehydrogenase (G6PD) deficiency)\n  * Use of vitamin C at a dose of \\> 1 gram daily within the 24 hours preceding first episode of qualifying organ dysfunction during a given ED or ICU admission\n  * Patients with HCC (beyond Milan) or extrahepatic malignancies\n  * Patients with HVOTO or EHPVO\n  * Pregnancy or active breastfeeding\n  * Current participation in another interventional research study\n  * Active or history of kidney stones\n  * History of chronic kidney disease or intrinsic kidney disease\n  * Patients already on maintenance hemodialysis prior to presentation\n  * Failure to provide informed consent\n  * Patients with retroviral infection\n  * Patients with active hemolysis due to alcohol or other causes or with hemoglobin below 7 gm\u002Fdl","ALL","18 Years",{"count":53,"type":54},110,"ESTIMATED","INTERVENTIONAL",[57],"NA","This study is testing whether Vitamin C can help improve kidney function and survival in very sick patients with liver disease. Patients with acute-on-chronic liver failure (ACLF) often develop serious infections that can lead to septic shock and kidney injury, which are major causes of death.\n\nIn this randomized controlled trial, patients with ACLF and septic shock will be assigned to receive either:\n\n1. Standard medical treatment alone, or\n2. Standard medical treatment plus intravenous Vitamin C.\n\nVitamin C is a safe, inexpensive antioxidant that may reduce inflammation, improve circulation, and protect the kidneys. The study will compare how well patients recover from septic shock and kidney injury in the two groups. Blood and urine samples will also be collected to look for biological markers that can predict outcomes.",[60],"Acute-on-Chronic Liver Failure (ACLF)",[62],"Sepsis, septic shock, Alcohol-related, ACLF, AKI, Lactate, Vitamin","NOT_YET_RECRUITING","2026-03-24",{"date":66,"type":67},"2026-03-25","ACTUAL",{"date":69,"type":54},"2026-04",{"date":71,"type":54},"2027-10",{"name":5,"class":6}]