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Title: A Multi-center Study of the Safety and Efficacy of N-acetylcysteine in the Treatment of Acute Liver Failure in Pediatric Patients Not Caused by Acetaminophen.      
available:
True
dateReleased:
11-03-2005
description:
We have completed patient enrollment in the the double blind, randomized, placebo-controlled trial of intravenous (IV) N-acetylcysteine (NAC) vs. placebo for the treatment of non-acetaminophen ALF. The purpose of this study is to examine the safety and efficacy of intravenous NAC in children with ALF for whom no antidote or other specific treatment is available. Inclusion in the NAC Study required enrollment in the Pediatric Acute Liver Failure (PALF) Study Registry.
privacy:
information not available
aggregation:
instance of dataset
ID:
NCT00248625
refinement:
curated
keywords:
acute liver failure
hepatic encephalopathy
acetaminophen toxicity
N-acetylcysteine
dateModified:
06-16-2016
availability:
available
types:
clinical trial
funders:
University of Pittsburgh
selectionCriteria:
Inclusion Criteria: - Meet entry criteria for and be enrolled in the Pediatric Acute Liver Failure prospective database. - Able to be evaluated and initiate treatment within the first 24 hours of hospitalization - Patients transferred from referring hospitals to the study site may be considered for enrollment, provided that no other treatment protocol has begun, and that no liver support device (BAL, extracorporeal liver assist device, transgenic pig perfusion) has been used or is contemplated. - Use of fresh frozen plasma infusions will not disqualify patients from participation. Exclusion Criteria: - older than 18 years of age - pregnancy - ALF that is secondary to acute acetaminophen toxicity, mushroom poisoning, or a known malignancy. - Patients who exhibit signs of cerebral herniation, have intractable arterial hypotension, require inotropic drugs, or demonstrate signs of sepsis (temperature ≥ 39.5o C or bacteremia) at the time of enrollment - No exclusion will be made on the basis of race, ethnic group or gender. - Criteria for inclusion of females and minorities will be those established in the NIH guidelines
studyGroups:
N-acetylcysteine (NAC)
placebo
ID:
IRB #: 0608007
types:
Interventional
accessURL: https://clinicaltrials.gov/ct2/show/results/NCT00248625
storedIn:
ClinicalTrial.gov
format:
HTML
accesstypes:
landing page
dateVerified:
20160601
authentication:
none
authorization:
none
creators:
University of Pittsburgh
homepage: https://clinicaltrials.gov
ID:
SCR:002309
name:
ClinicalTrials.gov

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