184
Participants
Start Date
January 31, 2000
Primary Completion Date
September 30, 2009
Study Completion Date
October 31, 2010
N-acetylcysteine
The study drug is administered as a continuous infusion at a dose of 150 mg/kg/day for up to 7 days following entry into the study. The infusion is discontinued at the time of death, liver transplant or discharge.
Placebo
Eligible children were adaptively allocated within strata defined by age (less than 2 years of age or at least 2 years old) and hepatic encephalopathy (grade 0-1 or 2-4) to receive N-acetylcysteine (150 mg/kg/d) in 5% dextrose (D5W) and water or placebo consisting of an equal volume of D5W alone. Volumes were adjusted for small children. Study medications were infused over 24 hours for up to 7 consecutive days in a dedicated line without other medications. Treatment was stopped earlier than 7 days in the case of hospital discharge, liver transplantation, or death within 7 days of randomization.
Mount Sinai Hospital, New York
Columbia-Presbyterian, New York
Children's Hospital of Pittsburgh of UPMC, Pittsburgh
Children's Hospital of Philadelphia, Philadelphia
Johns Hopkins University, Baltimore
Emory University, Children's Healthcare of Atlanta, Atlanta
University of Cincinnati, Cincinnati Children's Hospital, Cincinnati
Riley Children's Hospital, Indianapolis
University of Michigan, Ann Arbor
Children's Memorial Hospital, Chicago
St. Louis Children's Hospital, St Louis
Children's Medical Center of Dallas, Dallas
Baylor College of Medicine, Houston
University of Colorado, Denver Children's Hospital, Denver
University of California, San Francisco, San Francisco
University of Washington, Seattle
Harvard University, Boston Children's Hospital, Boston
Hospital for Sick Children, Toronto
Birmingham Children's Hospital, Birmingham
King's College Hospital (London, UK), London
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
University of Pittsburgh
OTHER