NCT00424957

Brief Summary

The purpose of the current study is to look into the pathogenesis of a severe medical condition causing acute episodes on the central nervous system as seen in majority of patients with liver cirrhosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2006

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 22, 2007

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

February 5, 2009

Status Verified

February 1, 2009

Enrollment Period

5 months

First QC Date

January 19, 2007

Last Update Submit

February 4, 2009

Conditions

CirrhosisHepatic Encephalopathy

Keywords

AmmoniaAstrocytesCitric acid cycleAlpha ketoglutarate dehydrogenase

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

6 patients with liver cirrhosis with an acute episode of hepatic encephalopathy, 6 patients with liver cirrhosis without an acute episode of hepatic encephalopathy, 6 healthy subjects age and sex matched

You may qualify if:

  • patients with liver cirrhosis with an acute episode of hepatic encephalopathy,
  • patients with liver cirrhosis without an acute episode of hepatic encephalopathy,
  • healthy subjects age and sex matched

You may not qualify if:

  • Neurological and/or psychiatric condition,
  • Non-treated diabetes,
  • Pregnancy/breast-feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PET Centre, Aarhus University Hospital

Aarhus, 8000, Denmark

Location

Related Publications (1)

  • Ott P, Clemmesen O, Larsen FS. Cerebral metabolic disturbances in the brain during acute liver failure: from hyperammonemia to energy failure and proteolysis. Neurochem Int. 2005 Jul;47(1-2):13-8. doi: 10.1016/j.neuint.2005.04.002.

    PMID: 15921824BACKGROUND

MeSH Terms

Conditions

FibrosisHepatic Encephalopathy

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsLiver FailureHepatic InsufficiencyLiver DiseasesDigestive System DiseasesBrain Diseases, MetabolicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Susanne Keiding, MD

    PET Centre and Medical department V, Aarhus Sygehus, Aarhus University Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 19, 2007

First Posted

January 22, 2007

Study Start

November 1, 2006

Primary Completion

April 1, 2007

Study Completion

October 1, 2008

Last Updated

February 5, 2009

Record last verified: 2009-02

Locations

DK(1)