Multicentre Cohort Study in Alcoholic Hepatitis

Not Applicable

• Conditions: Alcoholic hepatitis or acute decompensation of cirrhosis (control group); Digestive System

• Registration Number: ISRCTN24883155
• Lead Sponsor: Imperial College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-11
• Last Update Posted: 27 February 2023
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

1. Alcoholic Hepatitis group:
1.1 Aged 18 years or older
1.2 Clinical diagnosis of alcoholic hepatitis:
1.2.1 Serum bilirubin = 50µmol/L
1.2.2 History of excess alcohol (> 80g/day male, > 60g/day female) to within 2 months of recruitment
1.3 Less than 4 weeks since admission to hospital
1.4 Informed consent
The alcoholic hepatitis cohort will be subdivided into patients with Maddrey’s discriminant function =32, referred to as severe alcoholic hepatitis (SAH) and those with Maddrey’s discriminant function <32, referred to as non-severe alcoholic hepatitis (NSAH).

2. Acute Decompensation of Cirrhosis group:
2.1 Aged 18 years or older
2.2 Clinical or radiological diagnosis of liver cirrhosis
2.3 Acute development of one or more of the following complications:
2.3.1 Ascites
2.3.2 Encephalopathy
2.3.3 Gastrointestinal haemorrhage
2.3.4 Infection
2.4 Less than 4 weeks since admission to hospital
2.5 Informed consent
2.6 History of excess alcohol (> 80g/day male, > 60g/day female) for more than 5 years

Exclusion Criteria

1. Acute Decompensation of Cirrhosis group:
1.1 Abstinence of >2 months prior to randomisation
1.2 Duration of clinically apparent jaundice > 3 months
1.3 Other causes of liver disease including:
1.3.1 Evidence of active chronic viral hepatitis (Hepatitis B or C)
1.3.2 Biliary obstruction
1.3.3 Hepatocellular carcinoma
1.4 Evidence of current malignancy (except non-melanotic skin cancer)
1.5 HIV infection
1.6 Aspartate Aminotransferase (AST) >500 U/L or Alanine Aminotransferase (ALT) >300 U/L (not compatible with alcoholic hepatitis)
1.7 Patients with a serum creatinine >500 µmol/L or requiring renal support (see below)
1.8 Patients dependent upon inotropic support (adrenaline or noradrenaline). Terlipressin is allowed
1.9 Active gastrointestinal bleeding
1.10 Untreated infection
1.11 Pregnant or lactating women
1.12 Patients who cannot understand English

2. Acute Decompensation of Cirrhosis group:
2.1 Alcoholic Hepatitis (clinically or on histology)
2.2 Other causes of liver disease including:
2.2.1 Evidence of active chronic viral hepatitis (Hepatitis B or C)
2.2.2 Biliary obstruction
2.2.3 Hepatocellular carcinoma
2.3 Pregnant or lactating women
2.4 HIV infection
2.5 Patients who cannot understand English

Study & Design

• Study Type: Observational
• Study Design: Not specified