Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial (NCT07184866) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
110 participantsStarted 2026-04
Plain-language 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 serious infections that can lead to septic shock and kidney injury, which are major causes of death.
In this randomized controlled trial, patients with ACLF and septic shock will be assigned to receive either:
1. Standard medical treatment alone, or
2. Standard medical treatment plus intravenous Vitamin C.
Vitamin 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* ACLF as per asia pacific association for the study of liver (APASL criteria) with AKI according to KDIGO Criteria and septic shock.
Exclusion Criteria:
* • 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 pre…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Resolution of septic shock at 96 hours (Day 4)
Timeframe: Day 4 (96 hours) after randomization
Trial details
NCT IDNCT07184866
SponsorInstitute of Liver and Biliary Sciences, India