N-ACetylcysteine to Reduce Infection and Mortality for Alcoholic Hepatitis

  • STATUS
    Recruiting
  • End date
    Jun 1, 2025
  • participants needed
    42
  • sponsor
    Imperial College London
Updated on 16 November 2021
prednisolone
serum bilirubin level
n-acetylcysteine
n acetylcysteine

Summary

Recent data have suggested that monocyte oxidative burst defect is associated with the development of infection in patients with severe alcoholic hepatitis. One report found reduced 28 day mortality in patients treated with N-acetylcysteine combined with prednisolone when compared to prednisolone alone. The current study seeks to reveal whether the mechanism by which NAC reduces susceptibility to infection is through improvement of phagocyte oxidative burst.

Description

Randomised controlled trial, open label.

Details
Condition Hepatitis, ALCOHOLIC HEPATITIS, Infection
Treatment N-acetyl cysteine (NAC)
Clinical Study IdentifierNCT03069300
SponsorImperial College London
Last Modified on16 November 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Aged 18 years or older
Clinical alcoholic hepatitis
Serum bilirubin >80umol/L
History of alcohol excess (>80g/day male, >60g/day female)
Less than 4 weeks since admission to hospital
Maddrey's discriminant function (DF) >32
Informed consent

Exclusion Criteria

Alcohol abstinence of >6 weeks prior to randomisation
Duration of jaundice >3 months
Other causes of liver disease including
Evidence of viral hepatitis (hepatitis B or C)
Biliary obstruction
Hepatocellular carcinoma
Evidence of current malignancy (except non-melanotic skin cancer)
Previous entry into the study
Patients with known hypersensitivity or previous reactions to NAC
Pregnant or lactating women
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