N-Acetylcysteine in Severe Acute Alcoholic Hepatitis
- Registration Number
- NCT00962442
- Lead Sponsor
- Erasme University Hospital
- 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 Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 44
- Biopsy proven alcoholic hepatitis
- Severe disease defined by a Maddrey score superior to 32
- Neoplastic disease compromising 6 months survival
- HIV patients
- Hepatorenal syndrome
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description nutritional support + placebo placebo placebo perfusion for 14 days Beside usual meals patients must receive at least 27 kcal/kg/day enteral nutrition for 14 days nutritional support + N-Acétylcysteine N-Acetylcysteine N-Acétylcysteine 300 mg/kg intravenously for 14 days Beside usual meals, patients must receive at least 27 kcal/kg/day enteral nutrition for 14 days
- Primary Outcome Measures
Name Time Method Six months survival
- Secondary Outcome Measures
Name Time Method Rate of infections, clinical and biological parameters
Trial Locations
- Locations (1)
Erasme University Hospital
🇧🇪Brussels, Belgium