Treatment of Acute Severe Alcoholic Hepatitis With Corticoids Plus N Acetyl Cysteine Versus Corticoids Alone: a French Multicentre Randomized Controlled Study.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 174
- 试验地点
- 13
- 主要终点
- Survival at one, three and six months
研究概览
简要总结
35% of Acute Alcoholic Hepatitis patients (AAH) do not respond to corticoids and died after 6 months. Chronic alcohol abuse depletes glutathione in the hepatocytes and makes the latter more sensitive to excessive TNFα levels. Re-establishment of a stock of antioxidants by administration of a precursor (N-acetyl cysteine, NAC) in combination with corticoids (C) could make the hepatocytes more resistant and improve survival. The investigators' study's primary endpoint was improvement of survival at 6 months. The secondary endpoints were survival at 1 and 3 months, tolerance of NAC and a drop in blood bilirubin levels at D7
详细描述
AAH patients (Maddrey score > 32 and compatible histological results) should centrally randomized into the C-NAC or C groups. Both groups received 4 weeks of prednisolone treatment, plus NAC for the combination therapy group (D1: 150, 50 and 100 mg/kg in 250, 500 and 1000 mL of 5% glucose-saline (G5%) respectively, at t=30 minutes, 4 and 16 hours; D2 to D5, 100 mg/kg in 1000 mL of G5%). Group C received 1000 mL of G5%, D1-5
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient consent
- •Chronic alcohol intake in the last 3 to 6 months
- •Maddrey score ≥ 32
- •Liver histology compatible
排除标准
- •Hepato renal syndrome
- •Hepatocarcinoma
- •Recent variceal haemorrhage
- •Recent bacterial infections
- •Other liver diseases associated (HCV, HBV, hemochromatosis, AIH)
- •Cancers or cardiac and respiratory, HIV infection
- •NAC Allergy
- •No patient consent
- •Acetaminophen intoxication
研究组 & 干预措施
Corticoids plus N Acetyl Cysteine
40 mg/d prednisolone N Acetyl Cysteine infusion 150mg/kg in 30 minutes then 50 mg/kg in 4 h then 100mg/kg in 16 h and finally 100mg/d2 to d5
干预措施: Corticoids plus N Acetyl Cysteine (Drug)
结局指标
主要结局
Survival at one, three and six months
时间窗: six months
次要结局
- bilirubin decrease at day seven survival at one and three months nac tolerance side effects(one, three and six months)