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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Institute of Liver and Biliary Sciences, India · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 to septic shock, and acute kidney injury (AKI) is a common and life-threatening complication. Current treatment options are limited, and mortality remains very high. Vitamin C is a low-cost, widely available antioxidant and immune-modulating agent. It has shown promising results in patients with sepsis and septic shock by reducing oxidative stress, improving vascular tone, and supporting immune defense. However, its role in ACLF patients with septic shock and AKI has not been studied in a large, controlled trial. This interventional, randomized, open-label controlled trial will enroll patients with alcohol-related ACLF, septic shock, and AKI. Participants will be randomized 1:1 to receive either intravenous Vitamin C in addition to standard medical care, or standard care alone. Clinical outcomes, including resolution of shock, progression or resolution of AKI, need for renal replacement therapy, ICU/hospital stay, and survival at 7 and 28 days will be assessed. In addition, biospecimens (blood and urine) will be analyzed to identify biomarkers that predict outcomes and response to Vitamin C therapy. The study aims to provide evidence on the effectiveness of Vitamin C as an adjunctive therapy in this high-risk population, and to generate insights into the mechanisms of septic shock and kidney injury in ACLF.

Conditions

• Acute-on-Chronic Liver Failure (ACLF)

Interventions

Type	Name	Description
DRUG	Vitamin C	Intravenous Vitamin C, 25 mg/kg (maximum 1.5 g) every 6 hours for 5 days, administered in addition to standard medical treatment
OTHER	Standard of Care (SOC)	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

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-07-01
• Completion: 2027-10-01
• First posted: 2025-09-22
• Last updated: 2026-03-25