NCT01151475

Brief Summary

We wish to study patients with liver cirrhosis during and 2 weeks after an acute episode of liver coma (hepatic encephalopathy). By means of Positron Emission Tomography we investigate; brain blood flow, brain ammonia uptake and brain oxygen consumption. We hypothesize that blood flow an oxygen consumption is diminished and ammonia uptake increased during an acute episode of hepatic encephalopathy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2010

Shorter than P25 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

First Submitted

Initial submission to the registry

June 25, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 28, 2010

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

June 19, 2012

Status Verified

June 1, 2012

Enrollment Period

1 year

First QC Date

June 25, 2010

Last Update Submit

June 18, 2012

Conditions

Keywords

liver cirrhosishepatic encephalopathyammoniacerebral blood flow

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with hepatic encephalopathy

You may qualify if:

  • patients with an acute episode of hepatic encephalopathy

You may not qualify if:

  • previous stroke

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gitte Dam

Aarhus, 8000, Denmark

Location

MeSH Terms

Conditions

Liver CirrhosisHepatic Encephalopathy

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsLiver FailureHepatic InsufficiencyBrain Diseases, MetabolicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

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

Study Record Dates

First Submitted

June 25, 2010

First Posted

June 28, 2010

Study Start

August 1, 2010

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

June 19, 2012

Record last verified: 2012-06

Locations