Clinical Trial: Study of N-Acetylcysteine in Acute Liver Failure (ALF)

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Multi-Center Trial to Study Acute Liver Failure: N-Acetylcysteine (NAC) Open Label Use Study

Brief Summary: This proposed study is a multi-center open label study to determine if N-acetylcysteine has any survival benefits in patients with ALF.

Detailed Summary: 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 or placebo.
Sponsor: William Lee

Current Primary Outcome: The Primary Outcome is to Compare All Patients Who Survive (With or Without Transplant) to Those Who Die. [ Time Frame: 3 Weeks, 1-year and 2-year follow-ups ]

Original Primary Outcome: Same as current

Current Secondary Outcome: 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). [ Time Frame: 3 Weeks, 1-year and 2-year follow-ups ]

Original Secondary Outcome: Same as current

Information By: University of Texas Southwestern Medical Center

Dates:
Date Received: May 8, 2009
Date Started: December 2008
Date Completion:
Last Updated: January 29, 2014
Last Verified: January 2014