N-Acetylcysteine in Severe Acute Alcoholic Hepatitis

NCT ID: NCT00962442

Last Updated: 2009-08-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-09-30

Brief Summary

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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

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Conditions

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Alcoholic Hepatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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nutritional support + N-Acétylcysteine

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

Group Type ACTIVE_COMPARATOR

N-Acetylcysteine

Intervention Type DRUG

300 mg/kg for 14 days, intravenously

nutritional support + placebo

placebo perfusion for 14 days Beside usual meals patients must receive at least 27 kcal/kg/day enteral nutrition for 14 days

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Glucosé 5% perfusion for 14 days, intravenously

Interventions

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N-Acetylcysteine

300 mg/kg for 14 days, intravenously

Intervention Type DRUG

placebo

Glucosé 5% perfusion for 14 days, intravenously

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Biopsy proven alcoholic hepatitis
* Severe disease defined by a Maddrey score superior to 32

Exclusion Criteria

* Neoplastic disease compromising 6 months survival
* HIV patients
* Hepatorenal syndrome
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Erasme University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Erasme University Hospital

Locations

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Erasme University Hospital

Brussels, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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AAH-LYSO

Identifier Type: -

Identifier Source: org_study_id

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