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

September 9, 2016 updated by: University of Aarhus

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8000
        • Department of Medicine V, Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with alcoholic hepatitis admitted to hospital for treatment.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Alcoholic Hepatitis
Patients with alcoholic hepatitis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Functional Hepatic Nitrogen Clearance
Time Frame: At inclusion, after approximately 3 month and if severe alcoholic hepatitis also after 14 days medical treatment
At inclusion, after approximately 3 month and if severe alcoholic hepatitis also after 14 days medical treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical and biochemical measures of inflammation
Time Frame: At inclusion, after approximately 3 month and if severe alcoholic hepatitis also after 14 days medical treatment
At inclusion, after approximately 3 month and if severe alcoholic hepatitis also after 14 days medical treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Investigators

  • Principal Investigator: Karen Louise Thomsen, MD, Aarhus University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

November 15, 2010

First Submitted That Met QC Criteria

November 19, 2010

First Posted (Estimate)

November 22, 2010

Study Record Updates

Last Update Posted (Estimate)

September 12, 2016

Last Update Submitted That Met QC Criteria

September 9, 2016

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FHNC-Alk-Hep

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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