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.
ACLF as per asia pacific association for the study of liver (APASL criteria) with AKI according to KDIGO Criteria and septic shock.
• 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
Parallel
Vitamin C
DrugIntravenous Vitamin C, 25 mg/kg (maximum 1.5 g) every 6 hours for 5 days, administered in addition to standard medical treatment
Standard of Care (SOC)
Other interventionSupportive and guideline-based management of ACLF with septic shock and AKI, including antibiotics, fluids, vasopressors, renal replacement therapy as required, and other standard therapies
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.
Outcome of acute kidney injury (AKI) at Day 7
AKI resolution (decrease in stage by ≥1 or return to no AKI), persistence (same stage), or progression (increase in stage by ≥1 or need for dialysis in stage 3 patients), defined by KDIGO criteria.
Incidence of adverse events
Number and type of adverse events including hypotension, sepsis, bleeding, allergic reactions, anemia, kidney stones, urinary oxalate, hemolysis, and thrombocytopenia.
Need for renal replacement therapy
Proportion of patients requiring initiation of renal replacement therapy.
Duration of ICU stay
Number of days spent in ICU from randomization to discharge or death.
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This trial is not recruiting at the moment. You can still explore other options:
