Status:
NOT_YET_RECRUITING
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Lead Sponsor:
Institute of Liver and Biliary Sciences, India
Conditions:
Acute-on-Chronic Liver Failure (ACLF)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 seriou...
Detailed Description
Acute-on-chronic liver failure (ACLF) is a severe condition in which patients with chronic liver disease suddenly develop liver failure, often triggered by infection. Many of these patients progress t...
Eligibility Criteria
Inclusion
- ACLF as per asia pacific association for the study of liver (APASL criteria) with AKI according to KDIGO Criteria and septic shock.
Exclusion
- • Refractory Septic shock with more than 3 organ failures.
- Patients with age less than 18 years
- Known severe cardiopulmonary disease (structural or valvular heart disease, coronary artery disease, COPD)
- Patients in DIC with platelets \< 20,000 and INR \> 4 or active bleeding
- Limitations of care (defined as refusal of cardiovascular and respiratory support modes) including "do not intubate" (DNI) status
- Current hospitalization \> 15 days for patients with nosocomial acquisition of MDR at time of randomization
- Known allergy or contraindication to vitamin C (including previously or currently diagnosed primary hyperoxaluria and/or oxalate nephropathy, or known/suspected ethylene glycol ingestion,
- Known glucose-6-phosphate dehydrogenase (G6PD) deficiency)
- 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
- Patients with HCC (beyond Milan) or extrahepatic malignancies
- Patients with HVOTO or EHPVO
- Pregnancy or active breastfeeding
- Current participation in another interventional research study
- Active or history of kidney stones
- History of chronic kidney disease or intrinsic kidney disease
- Patients already on maintenance hemodialysis prior to presentation
- Failure to provide informed consent
- Patients with retroviral infection
- Patients with active hemolysis due to alcohol or other causes or with hemoglobin below 7 gm/dl
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT07184866
Start Date
October 1 2025
End Date
October 1 2027
Last Update
September 22 2025
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