NCT01245257

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

November 15, 2010

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 22, 2010

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

September 12, 2016

Status Verified

December 1, 2013

Enrollment Period

4.6 years

First QC Date

November 15, 2010

Last Update Submit

September 9, 2016

Conditions

Alcoholic Hepatitis

Keywords

InflammationUrea SynthesisCatabolismNitrogen balance

Outcome Measures

Primary Outcomes (1)

  • Functional Hepatic Nitrogen Clearance

    At inclusion, after approximately 3 month and if severe alcoholic hepatitis also after 14 days medical treatment

Secondary Outcomes (1)

  • Clinical and biochemical measures of inflammation

    At inclusion, after approximately 3 month and if severe alcoholic hepatitis also after 14 days medical treatment

Study Arms (1)

Alcoholic Hepatitis

Patients with alcoholic hepatitis

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with alcoholic hepatitis admitted to hospital for treatment.

You may qualify if:

  • Alcoholic hepatitis (alcohol intake (\> 40g/day in 6 months), bilirubin \> 80 μmol/l)

You may not qualify if:

  • Severe bacterial infections
  • Other chronical inflammatory diseases
  • Cancer
  • Other catabolic diseases
  • Treatment with prednisolone or pentoxifylline within the last 8 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Medicine V, Aarhus University Hospital

Aarhus, 8000, Denmark

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum, plasma, urine

MeSH Terms

Conditions

Hepatitis, AlcoholicInflammation

Condition Hierarchy (Ancestors)

HepatitisLiver DiseasesDigestive System DiseasesLiver Diseases, AlcoholicAlcohol-Induced DisordersAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Karen Louise Thomsen, MD

    Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2010

First Posted

November 22, 2010

Study Start

November 1, 2010

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

September 12, 2016

Record last verified: 2013-12

Locations

DK(1)