OBJECTIVES: 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.

Condition	Treatment or Intervention
Acute Liver Failure	Drug: acetylcysteine

Further Study Details: 

Expected Total Enrollment:  200

PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are randomized to receive intravenous acetylcysteine or placebo for 72 hours. Treatment must begin within 12 hours of hospitalization. Patients who advance to grade III or IV encephalopathy are eligible for liver transplantation. Patients are followed at 3 weeks.

Ages Eligible for Study:  18 Years   -   70 Years,  Genders Eligible for Study:  Both

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Acute liver failure (ALF) Hepatic illness that leads to grade II encephalopathy and coagulopathy (prothrombin time greater than 15 seconds), with no evidence of underlying chronic liver disease
• No ALF due to any of the following: Suspected acetaminophen or mushroom poisoning Pregnancy or pregnancy associated hemolysis and coagulopathy (HELLP syndrome) Intrahepatic malignancy
• No cerebral herniation

--Prior/Concurrent Therapy--

• No other prior or concurrent specific treatment protocol
• No prior or concurrent liver support device (BAL, extracorporeal liver-assist device, transgenic pig perfusion)
• Fresh frozen plasma infusions allowed
• No concurrent inotropic drugs

--Patient Characteristics--

• Age: 18 to 70
• Hematopoietic: Not specified
• Hepatic: See Disease Characteristics
• Renal: Not specified
• Cardiovascular: No intractable arterial hypotension (arterial systolic blood pressure 85 mmHg or less)
• Other: No severe sepsis (temperature greater than 39 C and/or significant bacteremia

Ezmina K. Lalani, BS      214 648-2665    ezmina.lalani@utsouthwestern.edu

Alabama
      University of Alabama at Birmingham, Birmingham,  Alabama,  35294-0005,  United States; Recruiting
Arizona
      Mayo Clinic, Scottsdale,  Arizona,  85259,  United States; Recruiting
California
      University of California San Francisco, San Francisco,  California,  94115,  United States; Recruiting
      University of California Los Angeles, Los Angeles,  California,  90024,  United States; Recruiting
      University of California Davis, Sacramento,  California,  95817,  United States; Recruiting
      University of California San Diego, San Diego,  California,  92103-0707,  United States; Recruiting
Florida
      Mayo Clinic, Jacksonville,  Florida,  32216,  United States; Recruiting
Illinois
      Northwestern University Medical School, Chicago,  Illinois,  60611,  United States; Recruiting
Massachusetts
      Massachusetts General Hospital, Boston,  Massachusetts,  02114,  United States; Recruiting
Michigan
      University of Michigan Health Systems, Ann Arbor,  Michigan,  48109,  United States; Recruiting
Minnesota
      Mayo Clinic, Rochester,  Minnesota,  55905,  United States; Recruiting
Missouri
      Washington University School of Medicine, Saint Louis,  Missouri,  63110,  United States; Recruiting
Nebraska
      University of Nebraska Medical Center, Omaha,  Nebraska,  68198-3330,  United States; Recruiting
New York
      Mount Sinai Medical Center, NY, New York,  New York,  10029,  United States; Recruiting
      New York Presbyterian Hospital, New York,  New York,  10032-3784,  United States; Recruiting
North Carolina
      Duke University Medical Center, Durham,  North Carolina,  27715,  United States; Recruiting
Oregon
      Oregon Health Sciences University, Portland,  Oregon,  97201-3098,  United States; Recruiting
Pennsylvania
      University of Pittsburgh Medical Center, Pittsburgh,  Pennsylvania,  15213,  United States; Recruiting
      Albert Einstein Medical Center, Philadelphia,  Pennsylvania,  19141,  United States; Recruiting
      University of Pennsylvania, Philadelphia,  Pennsylvania,  19104,  United States; Recruiting
South Carolina
      Medical University of South Carolina, Charleston,  South Carolina,  29425,  United States; Recruiting
Texas
      Baylor University Medical Center, Dallas,  Texas,  75246,  United States; Recruiting
      University of Texas Southwestern Medical Center at Dallas, Dallas,  Texas,  75235-8897,  United States; Recruiting
Virginia
      Virginia Commonwealth University, Richmond,  Virginia,  23298-0341,  United States; Recruiting
Washington
      University of Washington Medical Center, Seattle,  Washington,  98195-6043,  United States; Recruiting

Study chairs or principal investigators

William M. Lee, MD,  Study Chair,  University of Texas   

Study ID Numbers:  199/13925; UTSMC-1R03DK52827; UTSMC-IRB-0697-27200
Record last reviewed:  January 2005
Last Updated:  January 5, 2005
Record first received:  October 18, 1999
ClinicalTrials.gov Identifier:  NCT00004467
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08