Utility of the Use of N-acetylcysteine Associated With Conventional Treatment in Patients With Severe Acute Alcoholic Hepatitis (Maddrey> 32)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 390
- 试验地点
- 1
- 主要终点
- Number of Participants with all-cause mortality at 6 months.
研究概览
简要总结
This study is designed to evaluate the hypothesis that patients with severe acute alcoholic hepatitis have lower morbi-mortality if the patients receive treatment with corticosteroids + NAC, compared to patients that only receive corticosteroids.
详细描述
Currently there are no drugs available to cure patients with acute alcoholic hepatitis. The only treatment available is corticosteroids, the efficacy of which is limited and not free of side effects.
Other drugs that can contribute to improve the situation of patients with this entity is N-acetylcysteine (NAC), however, in the different studies contradictory data are obtained, therefore, different societies recommend conducting studies of greater scope to confirm the effectiveness of N-acetylcysteine and to be able to make a clear indication about N-acetylcysteines use.
Clinical, randomized, controlled, multicenter, parallel and open trial.
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
盲法说明
This is an open trial.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women.
- •Age from 18 to 75 years.
- •Patients with acute alcoholic hepatitis according to AASLD criteria or compatible liver histology.
- •Maddrey score> =
- •Acceptance of participation through written informed consent.
排除标准
- •Any cause of jaundice: acute hepatitis, positive HIV serology, biliary-pancreatic pathology, hemolytic anemia.
- •Allergy or intolerance to N-acetylcysteine and / or corticosteroids.
- •Hepatocarcinoma.
- •Portal cavernomatosis.
- •Portal cavernomatosis.
- •Any disease whose life expectancy is less than 12 months.
- •Patients with nitroglycerin and / or carbamazepine-based treatments.
- •Patients with uncontrolled active infection.
- •Acute kidney disease with creatinine> 2.5 mg / dL.
- •Uncontrolled upper gastrointestinal bleeding.
- •Concomitant uncontrolled diseases (HBV, HCV, HIV, TB, DILI, HCC or acute pancreatitis).
- •Multiple organ failure or shock.
研究组 & 干预措施
Corticosteroids
Corticosteroids following Standard Clinical Practice
干预措施: N-acetylcysteine (Drug)
Corticosteroids + N-acetylcysteine
Corticosteroids following Standard Clinical Practice plus N-acetylcisteine
干预措施: N-acetylcysteine (Drug)
结局指标
主要结局
Number of Participants with all-cause mortality at 6 months.
时间窗: 6 months.
Main result variable.
次要结局
- Number of participants with complications: infections, ascites, gastrointestinal bleeding, renal failure, hepatic encephalopathy, need for MARSH or orthotopic liver transplantation.(3 months)
研究者
Ana Belén Fernández Laso
Principal Investigator
Bioaraba Health Research Institute