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Heliac: Inflammation, Immune Activation and Portal Hypertension in Alcoholic Hepatitis

Sponsor
University of Aarhus (Other)
Overall Status
Completed
CT.gov ID
NCT00992888
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
25
Duration (Months)
2.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Prometheus Liver Dialysis system (Fresenius Medical Care)
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Inflammation, Immune Activation and Portal Hypertension in Alcoholic Hepatitis. A Pato-etiological Study With Focus on the Endotoxin Pathway.
Study Start Date :
Aug 1, 2009
Actual Primary Completion Date :
Sep 1, 2011
Actual Study Completion Date :
Sep 1, 2011

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Serum endotoxin levels [one year]

    Secondary Outcome Measures

    1. Endotoxin activation pathway proteins [1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 69 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Medicine V, Aarhus University Hospital Aarhus Denmark 8000

    Sponsors and Collaborators

    • University of Aarhus

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Thomas Damgaard Sandahl, Dr, University of Aarhus
    ClinicalTrials.gov Identifier:
    NCT00992888
    Other Study ID Numbers:
    • Heliac-01
    First Posted:
    Oct 9, 2009
    Last Update Posted:
    Sep 15, 2011
    Last Verified:
    Sep 1, 2011
    Keywords provided by Thomas Damgaard Sandahl, Dr, University of Aarhus
    Alcoholic Hepatitis
    Alcohol
    Endotoxin
    LPS
    Liver dialysis
    Innate immunity
    Toll Like receptors
    Additional relevant MeSH terms:
    Hepatitis A
    Hepatitis
    Hypertension, Portal
    Hepatitis, Alcoholic
    Hypertension
    Inflammation

    Study Results

    No Results Posted as of Sep 15, 2011