Effects of Prednisolone and Pentoxifylline on the Regulation of Urea Synthesis in Alcoholic Hepatitis

NCT ID: NCT01245257

Last Updated: 2016-09-12

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

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-11-30

Study Completion Date

2015-06-30

Brief Summary

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Loss of total mass of muscles (catabolism) is a serious clinical problem in patients with alcoholic hepatitis. The liver might play an important role in this stress-catabolism by increasing the production of urea during the inflammatory process.

The purpose of this study is to examine the regulation of urea synthesis in patients with alcoholic hepatitis and to study the effect of the anti-inflammatory drugs prednisolone and pentoxifylline on this regulation.

Detailed Description

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Conditions

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Alcoholic Hepatitis

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Study Groups

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Alcoholic Hepatitis

Patients with alcoholic hepatitis

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Alcoholic hepatitis (alcohol intake (\> 40g/day in 6 months), bilirubin \> 80 μmol/l)

Exclusion Criteria

* Severe bacterial infections
* Other chronical inflammatory diseases
* Cancer
* Other catabolic diseases
* Treatment with prednisolone or pentoxifylline within the last 8 weeks
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Karen Louise Thomsen, MD

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital

Locations

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Department of Medicine V, Aarhus University Hospital

Aarhus, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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FHNC-Alk-Hep

Identifier Type: -

Identifier Source: org_study_id

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