NCT00992888

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 8, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 9, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

September 15, 2011

Status Verified

September 1, 2011

Enrollment Period

2.1 years

First QC Date

October 8, 2009

Last Update Submit

September 14, 2011

Conditions

Alcoholic Hepatitis

Keywords

Alcoholic HepatitisAlcoholEndotoxinLPSLiver dialysisInnate immunityToll Like receptors

Outcome Measures

Primary Outcomes (1)

  • Serum endotoxin levels

    one year

Secondary Outcomes (1)

  • Endotoxin activation pathway proteins

    1 year

Study Arms (2)

albumin liver dialysis

EXPERIMENTAL
Device: Prometheus Liver Dialysis system (Fresenius Medical Care)

Standard medial care without dialysis

NO INTERVENTION

Interventions

Prometheus Liver Dialysis system (Fresenius Medical Care)DEVICE

6 hour dialysis for 3 consecutive days

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

Eligibility Criteria

Age18 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Liver biopsy when diagnosis is unclear.

You may not qualify if:

  • Heart failure
  • Pregnancy
  • non fluent danish speakers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Medicine V, Aarhus University Hospital

Aarhus, 8000, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 25501547DERIVED

MeSH Terms

Conditions

Hepatitis, Alcoholic

Condition Hierarchy (Ancestors)

HepatitisLiver DiseasesDigestive System DiseasesLiver Diseases, AlcoholicAlcohol-Induced DisordersAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced Disorders

Study Officials

  • Hendrik Vilstrup, Prof

    Department of Medicine V, Aarhus University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

October 8, 2009

First Posted

October 9, 2009

Study Start

August 1, 2009

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

September 15, 2011

Record last verified: 2011-09

Locations

DK(1)