Overview

N-acetylcysteine in Non-Acetaminophen Pediatric Acute Liver Failure

Status:
Completed
Trial end date:
2010-10-01
Target enrollment:
0
Participant gender:
All
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. 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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Pittsburgh
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Treatments:
Acetaminophen
Acetylcysteine
N-monoacetylcystine
Criteria
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