NCT00004467已完成3 期
Randomized Study of Acetylcysteine in Patients With Acute Liver Failure Not Caused by Acetaminophen
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)23 个研究点 分布在 1 个国家目标入组 173 人开始时间: 1998年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 173
- 试验地点
- 23
- 主要终点
- Overall survival rate
研究概览
简要总结
OBJECTIVES:
I. Determine the safety and efficacy of a short course (72 hours) of intravenous acetylcysteine in patients with acute liver failure for whom no antidote or specific treatment is available.
详细描述
PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are randomized to receive intravenous acetylcysteine or placebo for 72 hours. Treatment must begin within 12 hours of hospitalization. Patients who advance to grade III or IV encephalopathy are eligible for liver transplantation.
Patients are followed at 3 weeks.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
N-acetylcysteine (NAC)
Experimental
干预措施: N-acetylcysteine (NAC) (Drug)
结局指标
主要结局
Overall survival rate
时间窗: 3 weeks
次要结局
- Survival without liver transplantation (Spontaneous Survival(3 weeks)
- Transplant rate(3 weeks)
- Length of hospital stay(3 weeks)
- Number of organ systems showing failure(3 weeks)
研究者
研究点 (23)
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