Treatment of Severe Alcoholic Hepatitis With Corticoids Plus N Acetyl Cysteine Versus Corticoids Alone

Study Overview
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Brief Summary
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35% of Acute Alcoholic Hepatitis patients (AAH) do not respond to corticoids and died after 6 months. Chronic alcohol abuse depletes glutathione in the hepatocytes and makes the latter more sensitive to excessive TNFα levels. Re-establishment of a stock of antioxidants by administration of a precursor (N-acetyl cysteine, NAC) in combination with corticoids (C) could make the hepatocytes more resistant and improve survival. The investigators' study's primary endpoint was improvement of survival at 6 months. The secondary endpoints were survival at 1 and 3 months, tolerance of NAC and a drop in blood bilirubin levels at D7

Detailed Description
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AAH patients (Maddrey score > 32 and compatible histological results) should centrally randomized into the C-NAC or C groups. Both groups received 4 weeks of prednisolone treatment, plus NAC for the combination therapy group (D1: 150, 50 and 100 mg/kg in 250, 500 and 1000 mL of 5% glucose-saline (G5%) respectively, at t=30 minutes, 4 and 16 hours; D2 to D5, 100 mg/kg in 1000 mL of G5%). Group C received 1000 mL of G5%, D1-5

Official Title
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Treatment of Acute Severe Alcoholic Hepatitis With Corticoids Plus N Acetyl Cysteine Versus Corticoids Alone: a French Multicentre Randomized Controlled Study.

Conditions
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Alcoholic Hepatitis

Intervention / Treatment
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* Drug: Corticoids plus N Acetyl Cysteine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient consent Chronic alcohol intake in the last 3 to 6 months Maddrey score ≥ 32 Liver histology compatible Exclusion Criteria: Hepato renal syndrome Hepatocarcinoma Recent variceal haemorrhage Recent bacterial infections Other liver diseases associated (HCV, HBV, hemochromatosis, AIH) Cancers or cardiac and respiratory, HIV infection NAC Allergy No patient consent Acetaminophen intoxication

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Corticoids plus N Acetyl Cysteine<br>40 mg/d prednisolone N Acetyl Cysteine infusion 150mg/kg in 30 minutes then 50 mg/kg in 4 h then 100mg/kg in 16 h and finally 100mg/d2 to d5 | Drug: Corticoids plus N Acetyl Cysteine<br>* 40 mg/d prednisolone N Acetyl Cysteine infusion 150mg/kg in 30 minutes then 50 mg/kg in 4 h then 100mg/kg in 16 h and finally 100mg/d2 to d5<br>* Other names: AAH-NAC study;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival at one, three and six months |  | six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bilirubin decrease at day seven survival at one and three months nac tolerance side effects |  | one, three and six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Alcoholic Hepatitis, Cirrhosis, Alcohol, Alcoholic Liver disease