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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University of Aarhus
Sponsor:
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01245257
First received: November 15, 2010
Last updated: December 9, 2013
Last verified: December 2013
  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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Serum, plasma, urine


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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01245257

Contacts
Contact: Karen Louise Thomsen, MD +45 89493897 karethom@rm.dk

Locations
Denmark
Department of Medicine V, Aarhus University Hospital Recruiting
Aarhus, Denmark, 8000
Contact: Karen Louise Thomsen, MD    +45 89493897    karethom@rm.dk   
Sponsors and Collaborators
University of Aarhus
Investigators
Principal Investigator: Karen Louise Thomsen, MD Aarhus University Hospital
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01245257     History of Changes
Other Study ID Numbers: FHNC-Alk-Hep
Study First Received: November 15, 2010
Last Updated: December 9, 2013
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

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

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

ClinicalTrials.gov processed this record on August 19, 2014