Study of N-Acetylcysteine in Acute Liver Failure (ALF)
- Conditions
- Acute Liver FailureFulminant Hepatic Failure
- Interventions
- Registration Number
- NCT00896025
- Lead Sponsor
- University of Texas Southwestern Medical Center
- 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 malignancy will be eligible. Each patient will receive intravenously in solution of 5% dextrose in water containing N-acetylcysteine, beginning at a dose of 150 mg/kg bodyweight in 250 ml 5% dextrose over one hour, and in declining doses over a total of 72 hours. Care of patients and consideration of transplantation or other clinical decisions will not be affected by the study or the use of study drug.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 255
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description N-acetycylcysteine N-acetylcysteine 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.
- Primary Outcome Measures
Name Time Method Survival Rate With or Without Transplant 2-year follow-up The primary outcome is to compare all patients who survive (with or without transplant) to those who die.
- Secondary Outcome Measures
Name Time Method To Compare Patients Who Survive Without Transplantation to All Other Patients Enrolled in This Study (Those Who Receive a Transplant and Live, Those Who Receive a Transplant and Die, or Those Who Die Before Transplantation). 2-year follow-up The estimated minimum enrollment for any statistical validity was 100 patients. Due to low enrollment (8 participants) and the likelihood of generating any meaningful study data moving forward, the DSMB recommended the early termination of the study. Data was not collected since study was terminated.
Trial Locations
- Locations (21)
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
Scroll for more (11 remaining)University of Alabama at Birmingham🇺🇸Birmingham, Alabama, United States