Randomized Study of Acetylcysteine in Patients With Acute Liver Failure Not Caused by Acetaminophen
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.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
- Overall survival rate [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
- Survival without liver transplantation (Spontaneous Survival [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
- Transplant rate [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
- Length of hospital stay [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
- Number of organ systems showing failure [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 1998|
|Study Completion Date:||November 2006|
|Primary Completion Date:||November 2006 (Final data collection date for primary outcome measure)|
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.
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|Study Chair:||William M. Lee, MD||University of Texas|