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NCT00992888 Clinical Trial

Inflammation, Immune Activation and Portal Hypertension in Alcoholic Hepatitis

Alcoholic Hepatitis Clinical Trial

— Heliac  

Official title:
Inflammation, Immune Activation and Portal Hypertension in Alcoholic Hepatitis. A Pato-etiological Study With Focus on the Endotoxin Pathway.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00992888
Other study ID # Heliac-01
Secondary ID
Status Completed
Phase N/A
First received October 8, 2009
Last updated September 14, 2011
Start date August 2009
Est. completion date September 2011

Study information
Verified date September 2011
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Dataprotection Agency
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date September 2011
Est. primary completion date September 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 69 Years
Eligibility 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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

Intervention

Device:
• Prometheus Liver Dialysis system (Fresenius Medical Care)
6 hour dialysis for 3 consecutive days

Locations
Country Name City State
Denmark Department of Medicine V, Aarhus University Hospital Aarhus

Sponsors (1)
Lead Sponsor Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Serum endotoxin levels one year No
Secondary Endotoxin activation pathway proteins 1 year No
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