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

Primary Purpose

Alcoholic Hepatitis

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Prometheus Liver Dialysis system (Fresenius Medical Care)
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Alcoholic Hepatitis focused on measuring Alcoholic Hepatitis, Alcohol, Endotoxin, LPS, Liver dialysis, Innate immunity, Toll Like receptors

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Medicine V, Aarhus University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

albumin liver dialysis

Standard medial care without dialysis

Arm Description

Outcomes

Primary Outcome Measures

Serum endotoxin levels

Secondary Outcome Measures

Endotoxin activation pathway proteins

Full Information

First Posted
October 8, 2009
Last Updated
September 14, 2011
Sponsor
University of Aarhus
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1. Study Identification

Unique Protocol Identification Number
NCT00992888
Brief Title
Inflammation, Immune Activation and Portal Hypertension in Alcoholic Hepatitis
Acronym
Heliac
Official Title
Inflammation, Immune Activation and Portal Hypertension in Alcoholic Hepatitis. A Pato-etiological Study With Focus on the Endotoxin Pathway.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Aarhus

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholic Hepatitis
Keywords
Alcoholic Hepatitis, Alcohol, Endotoxin, LPS, Liver dialysis, Innate immunity, Toll Like receptors

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
albumin liver dialysis
Arm Type
Experimental
Arm Title
Standard medial care without dialysis
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Prometheus Liver Dialysis system (Fresenius Medical Care)
Other Intervention Name(s)
The prometheus albumin dialysis by Fresenius Medical Care
Intervention Description
6 hour dialysis for 3 consecutive days
Primary Outcome Measure Information:
Title
Serum endotoxin levels
Time Frame
one year
Secondary Outcome Measure Information:
Title
Endotoxin activation pathway proteins
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hendrik Vilstrup, Prof
Organizational Affiliation
Department of Medicine V, Aarhus University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Department of Medicine V, Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
25501547
Citation
Stoy S, Dige A, Sandahl TD, Laursen TL, Buus C, Hokland M, Vilstrup H. Cytotoxic T lymphocytes and natural killer cells display impaired cytotoxic functions and reduced activation in patients with alcoholic hepatitis. Am J Physiol Gastrointest Liver Physiol. 2015 Feb 15;308(4):G269-76. doi: 10.1152/ajpgi.00200.2014. Epub 2014 Dec 11.
Results Reference
derived

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Inflammation, Immune Activation and Portal Hypertension in Alcoholic Hepatitis

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