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CompletedNCT00992888HeliacUpdated Sep 15, 2011

Inflammation, Immune Activation and Portal Hypertension in Alcoholic Hepatitis

An interventional study of Prometheus Liver Dialysis system (Fresenius Medical Care) in Alcoholic Hepatitis, sponsored by University of Aarhus. Completed at 1 site in Denmark. Open to participants aged 18 Years to 69 Years. Per ClinicalTrials.gov, last updated 2011-09-15.

Sponsored by University of Aarhus · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 69 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Alcoholic Hepatitis

Keywords

  • Alcoholic Hepatitis
  • Alcohol
  • Endotoxin
  • LPS
  • Liver dialysis
  • Innate immunity
  • Toll Like receptors
03

In context

Hepatitis A

2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's planned enrollment of 60 is below the median of 100 across 1,886 interventional studies indexed under Hepatitis A.

Browse Hepatitis A studies →

Lead sponsor

University of Aarhus is the lead sponsor of 1,274 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 69 Years
Sexes eligible
All
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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    albumin liver dialysis

    Device: Prometheus Liver Dialysis system (Fresenius Medical Care)

  • No intervention
    Standard medial care without dialysis

Interventions

  • DevicePrometheus Liver Dialysis system (Fresenius Medical Care)

    6 hour dialysis for 3 consecutive days

    Also known as: The prometheus albumin dialysis by Fresenius Medical Care

06

What researchers measure

Primary outcomes

  1. Serum endotoxin levels

    Time frame: one year

Secondary outcomes

  1. Endotoxin activation pathway proteins

    Time frame: 1 year

07

Study locations

1 site
  • Department of Medicine V, Aarhus University Hospital
    Aarhus, 8000, Denmark
08

References and documents

Publications

  • 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. PubMed 25501547 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 15, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00992888
Lead sponsor
University of Aarhus
Responsible party
Thomas Damgaard Sandahl (Dr, University of Aarhus) — Principal investigator
First posted
Oct 9, 2009
Start date
Aug 2009
Primary completion
Sep 2011
Completion
Sep 2011
Last update
Sep 15, 2011

Study contacts

Hendrik Vilstrup, Prof
study director · Department of Medicine V, Aarhus University Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2011. You cannot join it, but the record below documents what was studied.

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