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

This study has been completed.
Information provided by (Responsible Party):
University of Aarhus Identifier:
First received: November 15, 2010
Last updated: September 9, 2016
Last verified: December 2013

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.

Alcoholic Hepatitis

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Effects of Prednisolone and Pentoxifylline on the Regulation of Urea Synthesis in Alcoholic Hepatitis

Resource links provided by NLM:

Further study details as provided by University of Aarhus:

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

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples Without DNA
Serum, plasma, urine

Estimated Enrollment: 50
Study Start Date: November 2010
Study Completion Date: June 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Alcoholic Hepatitis
Patients with alcoholic hepatitis


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with alcoholic hepatitis admitted to hospital for treatment.

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
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Please refer to this study by its identifier: NCT01245257

Department of Medicine V, Aarhus University Hospital
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Principal Investigator: Karen Louise Thomsen, MD Aarhus University Hospital
  More Information

Responsible Party: University of Aarhus Identifier: NCT01245257     History of Changes
Other Study ID Numbers: FHNC-Alk-Hep
Study First Received: November 15, 2010
Last Updated: September 9, 2016

Keywords provided by University of Aarhus:
Urea Synthesis
Nitrogen balance

Additional relevant MeSH terms:
Hepatitis, Alcoholic
Hepatitis A
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Liver Diseases, Alcoholic
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Methylprednisolone Hemisuccinate
Prednisolone acetate
Methylprednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs processed this record on May 25, 2017