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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01245257

Enrollment

Registered

2010-11-22

Start date

2010-11-30

Completion date

2015-06-30

Last updated

2016-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcoholic Hepatitis

Keywords

Inflammation, Urea Synthesis, Catabolism, Nitrogen balance

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.

Interventions

None listed

Study design

Observational model

CASE_CROSSOVER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Functional Hepatic Nitrogen Clearance	At inclusion, after approximately 3 month and if severe alcoholic hepatitis also after 14 days medical treatment

Secondary

Measure	Time frame
Clinical and biochemical measures of inflammation	At inclusion, after approximately 3 month and if severe alcoholic hepatitis also after 14 days medical treatment

Countries

Denmark

Outcome results