Inflammation, Immune Activation and Portal Hypertension in Alcoholic Hepatitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2011-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Alcoholic Hepatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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albumin liver dialysis

Group Type EXPERIMENTAL

Prometheus Liver Dialysis system (Fresenius Medical Care)

Intervention Type DEVICE

6 hour dialysis for 3 consecutive days

Standard medial care without dialysis

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Prometheus Liver Dialysis system (Fresenius Medical Care)

6 hour dialysis for 3 consecutive days

Intervention Type DEVICE

Other Intervention Names

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The prometheus albumin dialysis by Fresenius Medical Care

Eligibility Criteria

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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.