Status:
COMPLETED
N-acetylcysteine in Non-Acetaminophen Pediatric Acute Liver Failure
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Acute Liver Failure
Hepatic Encephalopathy
Eligibility:
All Genders
Up to 18 years
Phase:
PHASE3
Brief Summary
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. Th...
Detailed Description
The Pediatric Acute Liver Failure (PALF) Study Group to identify, characterize, and develop management strategies for infants, children and adolescents who present with acute liver failure. The PALF s...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
184 Patients enrolled
Trial Details
Trial ID
NCT00248625
Start Date
January 1 2000
End Date
October 1 2010
Last Update
July 28 2016
Active Locations (20)
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1
University of California, San Francisco
San Francisco, California, United States, 94143
2
University of Colorado, Denver Children's Hospital
Denver, Colorado, United States, 80218
3
Emory University, Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
4
Children's Memorial Hospital
Chicago, Illinois, United States, 60614