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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBioaraba Health Research Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • N-acetylcysteine

    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.

Treatment groups

390 Participants
are divided into 2 treatment groups
Group A: CorticosteroidsActive comparator 1 intervention
Group B: Corticosteroids + N-acetylcysteineExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of Participants with all-cause mortality at 6 months.

Main result variable.

Time frame
6 months.

Secondary outcomes

1

Number of participants with complications: infections, ascites, gastrointestinal bleeding, renal failure, hepatic encephalopathy, need for MARSH or orthotopic liver transplantation.

Security variable.

Time frame
3 months

Other outcomes

Sponsors and contacts

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