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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

Brief Summary:

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.


Detailed Summary:
Sponsor: University of Aarhus

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

Original Primary Outcome:

  • Functional Hepatic Nitrogen Clearance [ Time Frame: Before start of treatment ]
  • Functional Hepatic Nitrogen Clearance [ Time Frame: Two weeks after start of treatment ]


Current Secondary Outcome: 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 ]

Original Secondary Outcome:

  • Clinical and biochemical measures of inflammation [ Time Frame: Before start of treatment ]
  • Clinical and biochemical measures of inflammation [ Time Frame: Two weeks after start of treatment ]


Information By: University of Aarhus

Dates:
Date Received: November 15, 2010
Date Started: November 2010
Date Completion:
Last Updated: September 9, 2016
Last Verified: December 2013