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
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
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
NCT ID
NCT00992888
First Posted
October 8, 2009
Last Updated
September 14, 2011
Sponsor
University of Aarhus
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
Learn more about this trial
Inflammation, Immune Activation and Portal Hypertension in Alcoholic Hepatitis
We'll reach out to this number within 24 hrs