Study of N-Acetylcysteine in Acute Liver Failure (ALF)

Stopped early · Phase 4

Conditions studied: Acute Liver Failure, Fulminant Hepatic Failure

In brief

This proposed study is a multi-center open label study to determine if N-acetylcysteine has any survival benefits in patients with acute liver failure.

Key facts

Study ID

NCT00896025

Run by

University of Texas Southwestern Medical Center

People needed

255

Starts

2008-12-01

Expected to finish

2016-03-01

Last updated by the study team

2020-06-01

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Written Informed consent from patient's next of kin
• Altered mentation of any degree (encephalopathy)
• Evidence of moderately severe clotting abnormalities (international normalized ratio ≥ 1.5)
• A presumed acute illness onset of less than 26 weeks
• Admitted to study site hospital intensive care units with acute liver failure and who can be evaluated and started on treatment within the first 24 hours of hospitalization
• All subjects will be between 18 and 70 years
• The NIH guidelines on the inclusion of women and minorities as subjects will be observed

You may not qualify if…

• Patients less than age 18 or over 70 years of age
• Acetaminophen or mushroom poisoning induced liver failure
• Patients with a diagnosis of shock liver (ischemic hepatopathy)
• Acute liver failure of pregnancy
• Acute liver failure thought secondary to intra-hepatic malignancy
• Cerebral herniation
• Intractable arterial hypotension
• Severe sepsis (temperature >39º C and/or significant bacteremia) present at the time of enrollment

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• University of California, Los Angeles — Los Angeles, California, United States
• University of California, Davis — Sacramento, California, United States
• University of California, San Francisco — San Francisco, California, United States
• Mayo Clinic, Jacksonville — Jacksonville, Florida, United States
• Northwestern University Medical School — Chicago, Illinois, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• University of Michigan Medical Center — Ann Arbor, Michigan, United States
• Mayo Clinic, Rochester — Rochester, Minnesota, United States
• University of Nebraska — Omaha, Nebraska, United States
• Mount Sinai School of Medicine — New York, New York, United States
• New York Presbyterian Hospital (Columbia and Cornel) — New York, New York, United States
• Oregon Health Sciences University — Portland, Oregon, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Albert Einstein Medical Center — Philadelphia, Pennsylvania, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Baylor University Medical Center — Dallas, Texas, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• Virginia Commonwealth University — Richmond, Virginia, United States
• University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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