Comparing Nutritional Interventions in Patients With Alcohol-associated Hepatitis: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 2,000
- 主要终点
- Transplant free survival (30 days)
研究概览
简要总结
Alcohol-associated hepatitis (AH) is a life-threatening condition with high 90-days mortality (up to 40%) and limited treatment options. Previous studies have shown that decreased nutritional intake (less than 21 kcal/kg/day) is associated to a higher mortality compared to patients with a higher caloric intake. Additionally, it has been suggested that subjects with severe AH, should receive a high-protein diet, however, no specific trials have been carried out to address these questions. Thus, the investigators aim to compare nutritional interventions through a randomized controlled trial to assess if a strategy of peripheral parental nutrition (PPN) plus oral nutritional supplementation (ONS) improves outcomes in patients with severe AH. The investigators will compare standard oral intake, enhanced oral intake with IV fluid supplementation, and PPN plus ONS in patients admitted to hospital with severe AH. These results potentially will help guide practitioners on caloric benchmarks targets for patients with severe AH. This study will also assess specific risks and benefits of different nutritional interventions.
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
- •Adult (>18 years) patients admitted with acute severe AH based clinical diagnosis according to NIAAA criteria
- •Excessive alcohol consumption for more than 5 years in a row or interrupted
- •No more than 60 days of abstinence before the onset of jaundice
- •Bilirubin levels >3 mg/dL (>50 umol/L), AST>50 IU/mL, AST/ALT ratio > 1.5
- •Abstinence of other causes of liver disease
- •MELD score ≥ 20
排除标准
- •Age < 18 years
- •Pregnancy or lactation.
- •Allergy or intolerance to the enhanced oral intake formulation or PPN formulation.
- •Expected length of stay less than 48 hours.
- •Contraindications to IV fluid or PPN administration (fluid overload, suspected bacteremia).
- •Presence of drug-induced liver injury (DILI), ischemic hepatitis, biliary duct obstruction, viral hepatitis, autoimmune hepatitis, or Wilson's disease.
- •Extrahepatic neoplasia with a life expectancy of less than 6 months.
- •History of severe extrahepatic disease (e.g., chronic kidney failure requiring hemodialysis, severe heart disease (NYHA class ≥3), severe chronic lung disease (class ORO ≥3) that confers a survival of less than 6 months.
结局指标
主要结局
Transplant free survival (30 days)
时间窗: 30 days
30 days mortality (%)
次要结局
- Transplant free survival (90 days)(90 days)
研究者
Juan-Pablo Arab, MD
Associate Professor
Western University, Canada