Status:
TERMINATED
Study of N-Acetylcysteine in Acute Liver Failure (ALF)
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Acute Liver Failure
Fulminant Hepatic Failure
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
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.
Detailed Description
Patients admitted to study sites with carefully defined criteria for acute liver failure and who are thought not to have acetaminophen toxicity, mushroom poisoning, pregnancy-related liver failure, or...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
255 Patients enrolled
Trial Details
Trial ID
NCT00896025
Start Date
December 1 2008
End Date
March 1 2016
Last Update
June 1 2020
Active Locations (21)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
University of California, Los Angeles
Los Angeles, California, United States, 90095
3
University of California, Davis
Sacramento, California, United States, 95817
4
University of California, San Francisco
San Francisco, California, United States, 94143