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 range18 Years
SexALL
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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…
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