Study of N-Acetylcysteine in Acute Liver Failure (ALF) (ONAC)
Acute Liver Failure, Fulminant Hepatic Failure
About this trial
This is an interventional treatment trial for Acute Liver Failure focused on measuring Liver disease
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- University of Alabama at Birmingham
- University of California, Los Angeles
- University of California, Davis
- University of California, San Francisco
- Mayo Clinic, Jacksonville
- Northwestern University Medical School
- Massachusetts General Hospital
- University of Michigan Medical Center
- Mayo Clinic, Rochester
- University of Nebraska
- Mount Sinai School of Medicine
- New York Presbyterian Hospital (Columbia and Cornel)
- Oregon Health Sciences University
- University of Pennsylvania
- Albert Einstein Medical Center
- University of Pittsburgh Medical Center
- Medical University of South Carolina
- Baylor University Medical Center
- University of Texas Southwestern Medical Center
- Virginia Commonwealth University
- University of Washington
Arms of the Study
Arm 1
Arm 2
Active Comparator
No Intervention
N-acetycylcysteine
Standard of care
Each eligible Acute Liver Failure patient will be given N-acetylcysteine (NAC), beginning at a dose of 150 mg/kg bodyweight in 250 ml 5% dextrose over one hour, followed by 50 mg/kg in 500 ml 5% dextrose over four hours, and 125 mg/kg in 1000 ml 5% dextrose over 19 hours, then 150 mg/kg in 1000 ml 5% dextrose per 24 hours for an additional 48 hours. The patient will be on continuous N-acetylcysteine infusion for a total of 72 hours.
Each eligible Acute Liver Failure patient for whom the investigator chooses not to utilize N-acetylcysteine may serve as a control and receives standard of care.