Inflammation, Immune Activation and Portal Hypertension in Alcoholic Hepatitis (Heliac)

University of Aarhus

Status: Completed

Conditions: Alcoholic Hepatitis

Treatments: Device: Prometheus Liver Dialysis system (Fresenius Medical Care)

Study type: Interventional

Funder types: Other

Identifiers

NCT00992888

Heliac-01

Details and patient eligibility

About

The purpose of this study is to investigate the role of endotoxins and the endotoxin mediated immune activation pathway in patients with alcoholic hepatitis. Also, to determine the effect of Liver assist (liver dialyses) intervention on these parameters in patients with severe alcoholic hepatitis.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 69 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients with alcoholic hepatitis based on the following criteria

• Alcohol intake for 6 consecutive months above 40g /day, at admission or 3 months earlier.
• Serum bilirubin level above 80 mmol/l
• exclusion of other types of liver disease.
• Liver biopsy when diagnosis is unclear.

Exclusion criteria

• Heart failure
• Pregnancy
• non fluent danish speakers

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

albumin liver dialysis

Experimental group

Treatment:

Device: Prometheus Liver Dialysis system (Fresenius Medical Care)

Standard medial care without dialysis

No Intervention group