Liver CirrhosisNCT01151475
Cerebral Oxygen, Blood Flow and Ammonia Uptake in Patients With Cirrhosis and an Acute Episode of Hepatic Encephalopathy (HE)
An observational study of Liver Cirrhosis and Hepatic Encephalopathy, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Cirrhosis, Hepatic Encephalopathy
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2010to Aug 2011
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with hepatic encephalopathy
Who may be able to join
- patients with an acute episode of hepatic encephalopathy
Who cannot join
- previous stroke
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cerebral Oxygen, Blood Flow and Ammonia Uptake in Patients With Cirrhosis and an Acute Episode of HE
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.
- Conditions
- Liver Cirrhosis, Hepatic Encephalopathy
- Keywords
- liver cirrhosis, hepatic encephalopathy, ammonia, cerebral blood flow
- Medical subject headings
- Liver Cirrhosis, Hepatic Encephalopathy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2010 (estimated)
- Study startAug 2010
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver 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 only
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01151475
- Sponsor's protocol ID
- 24698
- Status last verified
- Jun 2012
- First submitted
- 25 Jun 2010
- Last updated
- 19 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Oxygen, Blood Flow and Ammonia Uptake in Patients With Cirrhosis and an Acute Episode of HE
- ClinicalTrials.gov ID
- NCT01151475
- Acronym / sponsor ID
- 24698
- Conditions
- Liver Cirrhosis, Hepatic Encephalopathy
- Keywords
- liver cirrhosis, hepatic encephalopathy, ammonia, cerebral blood flow
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 28 Jun 2010 (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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with hepatic encephalopathy
Key inclusion criteria (1 listed)
- patients with an acute episode of hepatic encephalopathy
Key exclusion criteria (1 listed)
- previous stroke
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 19 Jun 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Liver 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 1 inclusion and 1 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 19 Jun 2012. 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?
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 19 Jun 2012.