Alcoholic hepatitis or acute decompensation of cirrhosis (control group) Digestive System
Conditions
Interventions
Patients will continue to receive standard of care treatment throughout. Study participants will attend several test sessions where routine samples and other data will be collected.
A
Sponsors
Imperial College London
Eligibility
Sex/Gender
All
Inclusion criteria
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 80g/day male, > 60g/day female) for more than 5 years
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Validation of diagnostic and prognostic performance parameters for (Baseline, D28, D90): 1. Taurocholic acid diagnostic test to distinguish AH from AD 2. Transferrin, ELF and PNPLA3 genotype adjusted prognostic scores 3. Bacterial DNA, monocyte HLADR expression and oxidative burst for prediction of infection 4. Bacterial DNA for risk stratification before immunosuppressive therapy 5. Micro RNAs for prediction of AKI 6. BLISS assay for prediction of response to prednisolone | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Outcome at 28 and 90 days: 1.1 Mortality (rate) 1.2 Incidence of infection (rate) 1.3 Incidence of AKI (rate) 1.4 Incidence of recidivism (rate) 2. Outcome at 1, 5 and 10 years: 2.1 All-cause mortality (rate) 2.2 Liver-related mortality (rate) 2.3 Use of healthcare services (HES data) | — |
Countries
England, Scotland, United Kingdom, Wales
Contacts
Public ContactKarolina Bogdanowicz
Outcome results
None listed