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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 110
- 主要终点
- Resolution of septic shock at 96 hours (Day 4)
研究概览
简要总结
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:
- Standard medical treatment alone, or
- 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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ACLF as per asia pacific association for the study of liver (APASL criteria) with AKI according to KDIGO Criteria and septic shock.
排除标准
- •• 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 presentation
- •Failure to provide informed consent
- •Patients with retroviral infection
- •Patients with active hemolysis due to alcohol or other causes or with hemoglobin below 7 gm/dl
研究组 & 干预措施
Standard of Care (SOC)
Participants in this arm will receive standard medical treatment for ACLF with septic shock and acute kidney injury, as per institutional protocols.
干预措施: Standard of Care (SOC) (Other)
Vitamin C + Standard of Care
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
干预措施: Vitamin C (Drug)
结局指标
主要结局
Resolution of septic shock at 96 hours (Day 4)
时间窗: Day 4 (96 hours) after randomization
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.
次要结局
- 7-day mortality(Day 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)
- 28-day mortality(Day 28)
研究者
Rakhi Maiwall
Professor (hepatology)
Institute of Liver and Biliary Sciences, India