Randomized Study of Acetylcysteine in Patients With Acute Liver Failure Not Caused by Acetaminophen
NCT ID: NCT00004467
Last Updated: 2017-10-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
173 participants
INTERVENTIONAL
1998-06-30
2006-11-30
Brief Summary
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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.
Detailed Description
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Patients are followed at 3 weeks.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Placebo
Infusion of 5% dextrose
N-acetylcysteine (NAC)
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.
Interventions
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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.
Placebo
Infusion of 5% dextrose
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2. ALF patients where acetaminophen or mushroom poisoning is assessed or Suspected to be a significant contributing or sole cause of the illness. Both these diagnoses require specific antidote therapy, including NAC in the case of acetaminophen, rather than randomized or non-specific treatment.
3. Patients with a diagnosis of shock liver (ischemic hepatopathy), since the overall outcome for these patients in largely determined by the underlying etiology of the condition leading to shock. Heat stroke is not excluded.
4. Acute liver failure of pregnancy or the HELLP syndrome (pregnancy associated hemolysis and coagulopathy). The effect of NAC on the fetus or the mother has not been determined; in addition, pregnancy-related liver diseases usually mandate rapid delivery of the infant.
5. ALF thought secondary to intrahepatic malignancy. Patients with hepatic malignancy experiencing ALF have 100% mortality and are not transplant candidates.
6. Patients who exhibit signs of cerebral herniation at the time of enrollment.
7. Patients who demonstrate the presence of intractable arterial hypotension (arterial systolic blood pressure equal to or below 70 mmHg) present, or require inotropic drugs at the time of enrollment.
8. Severe sepsis (temperature \>39o C and/or significant bacteremia) present at the time of enrollment.
In general, acute liver failure (ALF) patients comprise somewhat more women than men, but there is no preponderance of any racial group, other than that expected on the basis of geographic differences. No exclusion will be made on the basis of race, ethnic group or gender. Criteria for inclusion of women and minorities will be those established in the NIH guidelines. Each study site will provide for review a log of patients considered for the NAC study with no identifiers, yielding only gender and age, race and reason for not participating as a check on gender or ethnic bias.
18 Years
70 Years
ALL
No
Sponsors
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University of Texas Southwestern Medical Center
OTHER
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Responsible Party
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Principal Investigators
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William M. Lee, MD
Role: STUDY_CHAIR
University of Texas Southwestern Medical Center at Dallas, Dallas, TX
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Mayo Clinic
Scottsdale, Arizona, United States
University of California Los Angeles
Los Angeles, California, United States
University of California Davis
Sacramento, California, United States
University of California San Diego
San Diego, California, United States
University of California San Francisco
San Francisco, California, United States
Mayo Clinic
Jacksonville, Florida, United States
Northwestern University Medical School
Chicago, Illinois, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Michigan Health Systems
Ann Arbor, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Mount Sinai Medical Center, NY
New York, New York, United States
New York Presbyterian Hospital
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, 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
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States
Baylor University Medical Center
Dallas, Texas, United States
Virginia Commonwealth University
Richmond, Virginia, United States
University of Washington Medical Center
Seattle, Washington, United States
Countries
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References
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Lee WM, Hynan LS, Rossaro L, Fontana RJ, Stravitz RT, Larson AM, Davern TJ 2nd, Murray NG, McCashland T, Reisch JS, Robuck PR; Acute Liver Failure Study Group. Intravenous N-acetylcysteine improves transplant-free survival in early stage non-acetaminophen acute liver failure. Gastroenterology. 2009 Sep;137(3):856-64, 864.e1. doi: 10.1053/j.gastro.2009.06.006. Epub 2009 Jun 12.
Stravitz RT, Fontana RJ, Karvellas C, Durkalski V, McGuire B, Rule JA, Tujios S, Lee WM; Acute Liver Failure Study Group. Future directions in acute liver failure. Hepatology. 2023 Oct 1;78(4):1266-1289. doi: 10.1097/HEP.0000000000000458. Epub 2023 May 16.
Singh S, Hynan LS, Rule JA, Lee WM. Changes in alpha-foetoprotein and Gc-globulin in relation to outcomes in non-acetaminophen acute liver failure. Liver Int. 2019 Dec;39(12):2368-2373. doi: 10.1111/liv.14216. Epub 2019 Sep 10.
Related Links
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Acute Liver Failure Study Group
Other Identifiers
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UTSMC-IRB-0697-27200
Identifier Type: OTHER
Identifier Source: secondary_id
199/13925 DK52827 (completed)
Identifier Type: -
Identifier Source: org_study_id
NCT00587366
Identifier Type: -
Identifier Source: nct_alias