Study of N-Acetylcysteine in Acute Liver Failure (ALF)

• Status: Terminated
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Texas Southwestern Medical Center; William Lee
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Treatments: Acetylcysteine; N-monoacetylcystine

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