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

September 14, 2011 updated by: Thomas Damgaard Sandahl, University of Aarhus

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8000
        • Department of Medicine V, Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: albumin liver dialysis
Device: Prometheus Liver Dialysis system (Fresenius Medical Care)
6 hour dialysis for 3 consecutive days
Other Names:
  • The prometheus albumin dialysis by Fresenius Medical Care
No Intervention: Standard medial care without dialysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Serum endotoxin levels
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
Endotoxin activation pathway proteins
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Investigators

  • Study Director: Hendrik Vilstrup, Prof, Department of Medicine V, Aarhus University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

October 8, 2009

First Submitted That Met QC Criteria

October 8, 2009

First Posted (Estimate)

October 9, 2009

Study Record Updates

Last Update Posted (Estimate)

September 15, 2011

Last Update Submitted That Met QC Criteria

September 14, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Heliac-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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