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Home > "R" Clinical Trials Conditions > Randomized Study of Acetylcysteine in Patients with Acute Liver Failure Not Caused by Acetaminophen  Randomized Study of Acetylcysteine in Patients with Acute Liver Failure Not Caused by Acetaminophen
Randomized Study of Acetylcysteine in Patients with Acute Liver Failure Not Caused by Acetaminophen
For Condition: Acute Liver Failure
Status: Recruiting
Sponsor(s): National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) , University of Texas
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 16 Years/70 Years
Genders: Both
Protocol Entry 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 Wilson's disease - 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: 16 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
Total Enrollment: 40
Location and Contact Information:
Overall Study Official:
WilliamLee, Study Chair, University of Texas
Mayo Clinic *Recruiting*
Rochester, Minnesota, 55905
United States
Recruiting J. Hay 507-266-8784
Washington University School of Medicine *Recruiting*
St. Louis, Missouri, 63110
United States
Recruiting Lawton Schick 314-362-9700
University of Michigan Health Systems *Recruiting*
Ann Arbor, Michigan, 48109
United States
Recruiting Robert Fontana 734-936-4780
UCSF/Mt. Zion Cancer Center *Recruiting*
San Francisco, California, 94115
United States
Recruiting Tim Davern 415-502-0610
University of Nebraska Medical Center *Recruiting*
Omaha, Nebraska, 68198-3330
United States
Recruiting Timothy McCashland 402-559-4871
University of California Los Angeles *Recruiting*
Los Angeles, California, 90024
United States
Recruiting Paul Martin 919-668-1124
Mount Sinai Medical Center, NY *Recruiting*
New York City, New York, 10029
United States
Recruiting Evren Atillasoy 212-241-1424
University of Pittsburgh Medical Center *Recruiting*
Pittsburgh, Pennsylvania, 15213
United States
Recruiting Jorge Rakela 412-383-7965
University of Miami School of Medicine *Recruiting*
Miami, Florida, 33136
United States
Recruiting Eugene Schiff 305-243-4615
University of Washington Medical Center *Recruiting*
Seattle, Washington, 98195-6043
United States
Recruiting Anne Larson 206-548-6700
University of Texas Southwestern Medical Center at Dallas *Recruiting*
Dallas, Texas, 75235-8897
United States
Recruiting William Lee 214-648-3323
Baylor University Medical Center *Recruiting*
Dallas, Texas, 75246
United States
Recruiting Jeffrey Crippin 214-820-6896
Northwestern University Medical School *Recruiting*
Chicago, Illinois, 60611
United States
Recruiting Andres Blei 312-908-5678
Oregon Health Sciences University *Recruiting*
Portland, Oregon, 97201-3098
United States
Recruiting Kent Benner 503-494-0367
Additional Information:
Study ID Numbers: 199/13925; UTSMC-1R03DK52827,UTSMC-IRB-0697-27200
Study Start Date: June 1998
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004467
Other Acute Liver Failure Studies:
1. Randomized Study of Acetylcysteine in Patients with Acute Liver Failure Not Caused by Acetaminophen
2. Prevention of Recurrent Hepatitis B after Liver Transplantation
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Randomized Study of Acetylcysteine in Patients with Acute Liver Failure Not Caused by Acetaminophen
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