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Randomized Study of Acetylcysteine in Patients With Acute Liver Failure Not Caused by Acetaminophen

NCT00004467 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 173

Last updated 2017-10-13

No results posted yet for this study

Summary

OBJECTIVES:

I. Determine the safety and efficacy of a short course (72 hours) of intravenous acetylcysteine in patients with acute liver failure for whom no antidote or specific treatment is available.

Conditions

  • Acute Liver Failure

Interventions

DRUG

N-acetylcysteine (NAC)

Infusion of 5% dextrose with N-acetylcysteine with an initial loading dose of 150 mg/kg/h of NAC over 1 hour, followed by 12.5 mg/kg/h for 4 hours, then continuous infusions of 6.25 mg/kg/h for the remaining 67 hours.

DRUG

Placebo

Infusion of 5% dextrose

Sponsors & Collaborators

  • University of Texas Southwestern Medical Center

    collaborator OTHER

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    lead NIH

Principal Investigators

  • William M. Lee, MD · University of Texas Southwestern Medical Center at Dallas, Dallas, TX

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1998-06-30
Primary Completion
2006-11-30
Completion
2006-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00004467 on ClinicalTrials.gov