Utility of the Use of N-acetylcysteine Associated With Conventional Treatment in Patients With Severe Acute Alcoholic Hepatitis (Maddrey> 32)

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

RECRUITING

Clinical Phase

NA

Total Enrollment

390 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-07

Study Completion Date

2026-12-31

Brief Summary

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This study is designed to evaluate the hypothesis that patients with severe acute alcoholic hepatitis have lower morbi-mortality if the patients receive treatment with corticosteroids + NAC, compared to patients that only receive corticosteroids.

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Detailed Description

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Currently there are no drugs available to cure patients with acute alcoholic hepatitis. The only treatment available is corticosteroids, the efficacy of which is limited and not free of side effects.

Other drugs that can contribute to improve the situation of patients with this entity is N-acetylcysteine (NAC), however, in the different studies contradictory data are obtained, therefore, different societies recommend conducting studies of greater scope to confirm the effectiveness of N-acetylcysteine and to be able to make a clear indication about N-acetylcysteines use.

Clinical, randomized, controlled, multicenter, parallel and open trial.

Conditions

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Alcoholic Hepatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Clinical, randomized, controlled, multicenter, parallel and open trial.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

This is an open trial.

Study Groups

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Corticosteroids

Corticosteroids following Standard Clinical Practice

Group Type ACTIVE_COMPARATOR

N-acetylcysteine

Intervention Type DRUG

Day 1: 150 mg/kg in 250ml 5% glucose over 30min + 50mgr/kg in 500ml glucose over 4h + 100mgr/kg in 1000ml glucose over 16h intravenously.

Day 2-14: 100mgr/kg in 1000 ml glucose/24h intravenously. Day 15 until end of corticosteroid treatment: NAC 600mg orally every 24h.

Corticosteroids + N-acetylcysteine

Corticosteroids following Standard Clinical Practice plus N-acetylcisteine

Group Type EXPERIMENTAL

N-acetylcysteine

Intervention Type DRUG

Day 1: 150 mg/kg in 250ml 5% glucose over 30min + 50mgr/kg in 500ml glucose over 4h + 100mgr/kg in 1000ml glucose over 16h intravenously.

Day 2-14: 100mgr/kg in 1000 ml glucose/24h intravenously. Day 15 until end of corticosteroid treatment: NAC 600mg orally every 24h.

Interventions

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N-acetylcysteine

Day 1: 150 mg/kg in 250ml 5% glucose over 30min + 50mgr/kg in 500ml glucose over 4h + 100mgr/kg in 1000ml glucose over 16h intravenously.

Day 2-14: 100mgr/kg in 1000 ml glucose/24h intravenously. Day 15 until end of corticosteroid treatment: NAC 600mg orally every 24h.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Men and women.
* Age from 18 to 75 years.
* Patients with acute alcoholic hepatitis according to AASLD criteria or compatible liver histology.
* Maddrey score\> = 32.
* Acceptance of participation through written informed consent.

Exclusion Criteria

* Any cause of jaundice: acute hepatitis, positive HIV serology, biliary-pancreatic pathology, hemolytic anemia.
* Allergy or intolerance to N-acetylcysteine and / or corticosteroids.
* Hepatocarcinoma.
* Portal cavernomatosis.
* Portal cavernomatosis.
* Any disease whose life expectancy is less than 12 months.
* Patients with nitroglycerin and / or carbamazepine-based treatments.
* Patients with uncontrolled active infection.
* Acute kidney disease with creatinine\> 2.5 mg / dL.
* Uncontrolled upper gastrointestinal bleeding.
* Concomitant uncontrolled diseases (HBV, HCV, HIV, TB, DILI, HCC or acute pancreatitis).
* Multiple organ failure or shock.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No