CirrhosisNCT00424957
Brain Energy Metabolism in Patients With Chronic Liver Disease and Impaired Central Nervous System
An observational study of Cirrhosis and Hepatic Encephalopathy, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cirrhosis, Hepatic Encephalopathy
- How many people
- 18 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2006to Oct 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Neurological and/or psychiatric condition,
- Non-treated diabetes,
- Pregnancy/breast-feeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Brain Energy Metabolism in Patients With Acute Hepatic Encephalopathy Measured With PET
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.
- Conditions
- Cirrhosis, Hepatic Encephalopathy
- Keywords
- Ammonia, Astrocytes, Citric acid cycle, Alpha ketoglutarate dehydrogenase
- Medical subject headings
- Fibrosis, Hepatic Encephalopathy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2007 (estimated)
- Study startNov 2006
- Primary completionApr 2007
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Investigators
- Susanne Keiding, MD, Study chair, PET Centre and Medical department V, Aarhus Sygehus, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00424957
- Sponsor's protocol ID
- 20060120
- Status last verified
- Feb 2009
- First submitted
- 19 Jan 2007
- Last updated
- 5 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 15921824
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Energy Metabolism in Patients With Acute Hepatic Encephalopathy Measured With PET
- ClinicalTrials.gov ID
- NCT00424957
- Acronym / sponsor ID
- 20060120
- Conditions
- Cirrhosis, Hepatic Encephalopathy
- Keywords
- Ammonia, Astrocytes, Citric acid cycle, Alpha ketoglutarate dehydrogenase
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Nov 2006
- Primary completion
- Apr 2007 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 22 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Neurological and/or psychiatric condition,
- Non-treated diabetes,
- Pregnancy/breast-feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2009.
- Background: PubMed 15921824Ott 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susanne Keiding, MD study chair
PET Centre and Medical department V, Aarhus Sygehus, Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cirrhosis and Hepatic Encephalopathy, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00424957, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2009.