Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial

NCT07184866 | Not Yet Recruiting

• 2 other identifiers: IEC/2024/116/MA02IEC approval number
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

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 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. 1.Standard medical treatment alone, or
2. 2.Standard medical treatment plus intravenous Vitamin C.

Conditions

Acute-on-Chronic Liver Failure (ACLF)

Keywords

Sepsis, septic shock, Alcohol-related, ACLF, AKI, Lactate, Vitamin

Outcome Measures

Primary Outcomes (1)

• Resolution of septic shock at 96 hours (Day 4)

  Resolution of septic shock is defined as maintenance of mean arterial pressure (MAP) ≥ 65 mmHg for ≥ 6 consecutive hours after complete discontinuation of all vasopressor support, without restarting vasopressors during that 6-hour period.

  Day 4 (96 hours) after randomization

Secondary Outcomes (7)

• Outcome of acute kidney injury (AKI) at Day 7

  Day 7

• Incidence of adverse events

  Day 7, Day 14, Day 28 or until hospital discharge, whichever occurs first

• Need for renal replacement therapy

  Day 7

• Duration of ICU stay

  Through hospital discharge or death, up to 28 days

• Duration of hospital stay

  Up to Day 28

Study Arms (2)

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.

Other: Standard of Care (SOC)

Vitamin C + Standard of Care

EXPERIMENTAL

Participants in this arm will receive intravenous Vitamin C (25 mg/kg, 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

Drug: Vitamin C

Interventions

Vitamin C DRUG

Intravenous Vitamin C, 25 mg/kg (maximum 1.5 g) every 6 hours for 5 days, administered in addition to standard medical treatment

Also known as: (Ascorbic Acid)

Vitamin C + Standard of Care

Standard of Care (SOC) OTHER

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

Standard of Care (SOC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ACLF as per asia pacific association for the study of liver (APASL criteria) with AKI according to KDIGO Criteria and septic shock.

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

MeSH Terms

Conditions

Acute-On-Chronic Liver Failure; Sepsis; Shock, Septic

Interventions

Ascorbic Acid; Standard of Care

Condition Hierarchy (Ancestors)

Liver Failure, Acute; Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Dr. Rakhi Maiwall, MBBS, MD, DM

CONTACT

+91 8750343085; rakhi_2011@yahoo.co.in

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor (hepatology)

Study Record Dates

• First Submitted: September 13, 2025
• First Posted: September 22, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: March 25, 2026

Record last verified: 2026-03