This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor the Center, which is not necessarily the institution for the investigator.The purpose of this study is to test whether a drug called N-Acetylcysteine (NAC) given as an intravenous (in the vein) infusion improves survival for children with acute liver failure (ALF) that is not due to acetaminophen.The initial basis for this treatment with NAC is the benefit demonstrated in subjects with acetaminophen (Tylenol) overdose. From this initial observation, uncontrolled observational studies in adults suggest that NAC may improve the outcome of ALF from causes other than acetaminophen. NAC may help the liver's ability to recover from a variety of insults. IV- NAC is used in Europe and Canada for treatment of acetaminophen overdose induced ALF and non-acetaminophen induced ALF and has recently been approved for this use in acetaminophen overdose in the US. However, IV-NAC has not been tested or approved in the U.S. for non-acetaminophen ALF. This study is part of a national program to test the value of an IV infusion of NAC (IV-NAC) in those children with ALF NOT due to acetaminaphen. Safety and efficacy and overall 1 year survival (with or without liver transplantation) of a 7 day course of intravenous N-Acetylcysteine in children with ALF for whom no antidote or other specific treatment is available will be studied.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000069-45
Application #
7605100
Study Section
Special Emphasis Panel (ZRR1-CR-9 (01))
Project Start
2007-03-01
Project End
2008-02-29
Budget Start
2007-03-01
Budget End
2008-02-29
Support Year
45
Fiscal Year
2007
Total Cost
$5,538
Indirect Cost
Name
University of Colorado Denver
Department
Pediatrics
Type
Schools of Medicine
DUNS #
041096314
City
Aurora
State
CO
Country
United States
Zip Code
80045
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