Skip to main content
OpenTrials
Completed

NCT Number: NCT00992888

Inflammation, Immune Activation and Portal Hypertension in Alcoholic Hepatitis

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Alcoholic Hepatitis Alcohol-Induced Disorders Alcohol-Related Disorders Chemically-Induced Disorders Digestive System Diseases Hepatitis Hepatitis, Alcoholic Liver Diseases Liver Diseases, Alcoholic Substance-Related Disorders

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Medicine V, Aarhus University Hospital

Aarhus, 8000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prometheus Liver Dialysis system (Fresenius Medical Care)

Device

6 hour dialysis for 3 consecutive days

Other names: The prometheus albumin dialysis by Fresenius Medical Care

Primary outcomes

  1. Serum endotoxin levels

    Time frame: one year

Secondary outcomes

  1. Endotoxin activation pathway proteins

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

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

Acronym: Heliac

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Oct 9, 2009
Registry last updated
Sep 15, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.