Inflammation, Immune Activation and Portal Hypertension in Alcoholic Hepatitis

Not Applicable

Completed

• Conditions: Alcoholic Hepatitis
• Interventions: Device: Prometheus Liver Dialysis system (Fresenius Medical Care)

• Registration Number: NCT00992888
• Lead Sponsor: University of Aarhus

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-10-08
• Study First Submitted QC: 2009-10-08
• Study First Posted: 2009-10-09
• Status Verified: 2011-09
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Last Update Submitted: 2011-09-14
• Last Update Posted: 2011-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
albumin liver dialysis	Prometheus Liver Dialysis system (Fresenius Medical Care)	-

Primary Outcome Measures

Name	Time	Method
Serum endotoxin levels	one year

Secondary Outcome Measures

Name	Time	Method
Endotoxin activation pathway proteins	1 year

Trial Locations

Locations (1)

Department of Medicine V, Aarhus University Hospital; 🇩🇰 Aarhus, Denmark