A Multi-Center Trial to Study Acute Liver Failure: N-Acetylcysteine (NAC) Open Label Use Study
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 255
- 试验地点
- 21
- 主要终点
- Survival Rate With or Without Transplant
研究概览
简要总结
This proposed study is a multi-center open label study to determine if N-acetylcysteine has any survival benefits in patients with acute liver failure.
详细描述
Patients admitted to study sites with carefully defined criteria for acute liver failure and who are thought not to have acetaminophen toxicity, mushroom poisoning, pregnancy-related liver failure, or malignancy will be eligible. Each patient will receive intravenously in solution of 5% dextrose in water containing N-acetylcysteine, beginning at a dose of 150 mg/kg bodyweight in 250 ml 5% dextrose over one hour, and in declining doses over a total of 72 hours. Care of patients and consideration of transplantation or other clinical decisions will not be affected by the study or the use of study drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Written Informed consent from patient's next of kin
- •Altered mentation of any degree (encephalopathy)
- •Evidence of moderately severe clotting abnormalities (international normalized ratio ≥ 1.5)
- •A presumed acute illness onset of less than 26 weeks
- •Admitted to study site hospital intensive care units with acute liver failure and who can be evaluated and started on treatment within the first 24 hours of hospitalization
- •All subjects will be between 18 and 70 years
- •The NIH guidelines on the inclusion of women and minorities as subjects will be observed
排除标准
- •Patients less than age 18 or over 70 years of age
- •Acetaminophen or mushroom poisoning induced liver failure
- •Patients with a diagnosis of shock liver (ischemic hepatopathy)
- •Acute liver failure of pregnancy
- •Acute liver failure thought secondary to intra-hepatic malignancy
- •Cerebral herniation
- •Intractable arterial hypotension
- •Severe sepsis (temperature >39º C and/or significant bacteremia) present at the time of enrollment
研究组 & 干预措施
N-acetycylcysteine
Each eligible Acute Liver Failure patient will be given N-acetylcysteine (NAC), beginning at a dose of 150 mg/kg bodyweight in 250 ml 5% dextrose over one hour, followed by 50 mg/kg in 500 ml 5% dextrose over four hours, and 125 mg/kg in 1000 ml 5% dextrose over 19 hours, then 150 mg/kg in 1000 ml 5% dextrose per 24 hours for an additional 48 hours. The patient will be on continuous N-acetylcysteine infusion for a total of 72 hours.
干预措施: N-acetylcysteine (Drug)
结局指标
主要结局
Survival Rate With or Without Transplant
时间窗: 2-year follow-up
The primary outcome is to compare all patients who survive (with or without transplant) to those who die.
次要结局
- To Compare Patients Who Survive Without Transplantation to All Other Patients Enrolled in This Study (Those Who Receive a Transplant and Live, Those Who Receive a Transplant and Die, or Those Who Die Before Transplantation).(2-year follow-up)