Clinical Trial: N-Acetylcysteine in Severe Acute Alcoholic Hepatitis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: N-Acetylcysteine for the Treatment of Alcoholic Hepatitis: a Belgian Multicenter Randomised Trial

Brief Summary: Acute alcoholic hepatitis (AAH) is the most severe form of alcoholic liver disease (ALD) and is associated with a high risk of dying in the short term. Corticosteroids are generally recommended in patients with severe AAH, but its use is still controverted and contraindicated in case of active infection or gastrointestinal bleeding. Therefore, alternative therapeutic options are needed.Ethanol consumption results in the depletion of endogenous antioxidant capabilities and patients with ALD have evidence of antioxidant deficiencies.Due to its effects on glutathion stores restoration and as such the limitation of the oxidative stress and its good tolerance and safety profile, N-acetylcysteine (NAC) is an attractive agent for the treatment of AAH.In this context, we hypothesized that NAC might be beneficial in severe AAH.

Detailed Summary:
Sponsor: Erasme University Hospital

Current Primary Outcome: Six months survival

Original Primary Outcome: Same as current

Current Secondary Outcome: Rate of infections, clinical and biological parameters

Original Secondary Outcome: Same as current

Information By: Erasme University Hospital

Dates:
Date Received: August 19, 2009
Date Started: September 2000
Date Completion:
Last Updated: August 19, 2009
Last Verified: August 2009