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

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.

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Key information

Conditions

Alcoholic Hepatitis Alcohol-Induced Disorders Alcohol-Related Disorders Chemically-Induced Disorders Digestive System Diseases Hepatitis Hepatitis, Alcoholic Inflammation Liver Diseases Liver Diseases, Alcoholic Pathologic Processes Pathological Conditions, Signs and Symptoms Substance-Related Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Medicine V, Aarhus University Hospital

Aarhus, 8000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Functional Hepatic Nitrogen Clearance

Time frame: At inclusion, after approximately 3 month and if severe alcoholic hepatitis also after 14 days medical treatment

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Important dates

Study start: 2010
Primary completion: 2015
Study completion: 2015
First posted: Nov 22, 2010
Registry last updated: Sep 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed