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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01245257
First Posted: November 22, 2010
Last Update Posted: September 12, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Aarhus
  Purpose

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.


Condition
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)
Groups/Cohorts
Alcoholic Hepatitis
Patients with alcoholic hepatitis

  Eligibility

Information from the National Library of Medicine

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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.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01245257


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

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01245257     History of Changes
Other Study ID Numbers: FHNC-Alk-Hep
First Submitted: November 15, 2010
First Posted: November 22, 2010
Last Update Posted: September 12, 2016
Last Verified: December 2013

Keywords provided by University of Aarhus:
Inflammation
Urea Synthesis
Catabolism
Nitrogen balance

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Alcoholic
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
Prednisolone acetate
Methylprednisolone acetate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Pentoxifylline
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents