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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Thomas Damgaard Sandahl, University of Aarhus
ClinicalTrials.gov Identifier:
NCT00992888
First received: October 8, 2009
Last updated: September 14, 2011
Last verified: September 2011
History of Changes
  Purpose

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 Intervention
Alcoholic Hepatitis
 Device: Prometheus Liver Dialysis system (Fresenius Medical Care)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Serum endotoxin levels [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Endotoxin activation pathway proteins [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: August 2009
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: albumin liver dialysis Device: Prometheus Liver Dialysis system (Fresenius Medical Care)
6 hour dialysis for 3 consecutive days
Other Name: The prometheus albumin dialysis by Fresenius Medical Care
No Intervention: Standard medial care without dialysis

  Eligibility

Ages Eligible for Study:   18 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00992888

Locations
Denmark
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
  More Information

No publications provided

Responsible Party: Thomas Damgaard Sandahl, Dr, University of Aarhus
ClinicalTrials.gov Identifier: NCT00992888     History of Changes
Other Study ID Numbers: Heliac-01
Study First Received: October 8, 2009
Last Updated: September 14, 2011
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by University of Aarhus:
Alcoholic Hepatitis
Alcohol
Endotoxin
LPS
 Liver dialysis
Innate immunity
Toll Like receptors

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Alcoholic
Hypertension
Hypertension, Portal
Inflammation
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
 Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Liver Diseases, Alcoholic
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013