Fulminant Hepatic FailureNCT00836420
Cerebral Microdialysis in Patients With Fulminant Hepatic Failure
An observational study of Fulminant Hepatic Failure, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
Patients with fulminant hepatic failure (FHF) often develop cerebral edema, high intracranial pressure (ICP)that may result in fatal brain damage. The aim in this protocol is to determine if a rise in the brain concentration of glutamate, lactate and pyruvate are involved in development of surges of high ICP in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fulminant Hepatic Failure
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2000to Oct 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: consecutive patients with fulminant hepatic failure
Who may be able to join
- All patients with fulminant hepatic failure
Who cannot join
- Age below 18 years
- Pregnancy
- Not obtained informed consent
- Suspicion of cancer disease
- No pupil reaction to light
Trial locations and contacts
1 site in 1 country.
About this study
Patients with fulminant hepatic failure (FHF) often develop cerebral edema, high intracranial pressure (ICP)that may result in fatal brain damage. The aim in this protocol is to determine if a rise in the brain concentration of glutamate, lactate and pyruvate are involved in development of surges of high ICP in patients with FHF. The study is observatory in nature and also record the influence of any intervention that may e instituted during the course of the critical illness.
Read the detailed description
Fulminant hepatic failure (FHF) is often complicated by cerebral edema, high intracranial pressure (ICP) and brain death. Accordingly the intracranial pressure is often monitored in such patients in order to be able to institute treatment before high ICP evolves. As routinely done in patients with severe head injury a microdialysis monitoring catheter is also placed under this procedure to measure metabolic changes that are responsible for surges of high ICP. The aim in this descriptive protocol is to determine if a rise in glutamate, lactate and pyruvate concentration in the brain cortex are involved in development of surges of high ICP in patients with FHF. The study is observatory in nature and also record the influence of any intervention during the course of the critical illness.
- Conditions
- Fulminant Hepatic Failure
- Being tested
- no intervention
- Keywords
- ammonia, acute liver failure, brain edema, oxidative metabolism, intracranial pressure
- Medical subject headings
- Liver Failure, Acute, Brain Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionProcedure or surgery
the value of the clinical use of microdialysis monitoring of the brain
| Study group | Role | What they receive |
|---|---|---|
| liver | patients with acute liver failure Receives: Procedure: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain lactate concentration and intracranial hypertension
to determine if brain oxidative metabolism correlates with brain edema and high intracranial pressure
Measured: 2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2009 (estimated)
- Study startJan 2000
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Fulminant Hepatic FailureStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Fin Stolze Larsen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Fin Stolze Larsen, Study chair, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00836420
- Sponsor's protocol ID
- KF 00/002
- Status last verified
- Oct 2015
- First submitted
- 3 Feb 2009
- Last updated
- 27 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Tofteng F, Jorgensen L, Hansen BA, Ott P, Kondrup J, Larsen FS. Cerebral microdialysis in patients with fulminant hepatic failure. Hepatology. 2002 Dec;36(6):1333-40. doi: 10.1053/jhep.2002.36944.
PubMed 12447856Bjerring PN, Hauerberg J, Jorgensen L, Frederiksen HJ, Tofteng F, Hansen BA, Larsen FS. Brain hypoxanthine concentration correlates to lactate/pyruvate ratio but not intracranial pressure in patients with acute liver failure. J Hepatol. 2010 Dec;53(6):1054-8. doi: 10.1016/j.jhep.2010.05.032. Epub 2010 Aug 3.
PubMed 20800925Bjerring PN, Hauerberg J, Frederiksen HJ, Jorgensen L, Hansen BA, Tofteng F, Larsen FS. Cerebral glutamine concentration and lactate-pyruvate ratio in patients with acute liver failure. Neurocrit Care. 2008;9(1):3-7. doi: 10.1007/s12028-008-9060-4.
PubMed 18250976Tofteng F, Hauerberg J, Hansen BA, Pedersen CB, Jorgensen L, Larsen FS. Persistent arterial hyperammonemia increases the concentration of glutamine and alanine in the brain and correlates with intracranial pressure in patients with fulminant hepatic failure. J Cereb Blood Flow Metab. 2006 Jan;26(1):21-7. doi: 10.1038/sj.jcbfm.9600168.
PubMed 15959460
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Microdialysis in Patients With Fulminant Hepatic Failure
- ClinicalTrials.gov ID
- NCT00836420
- Acronym / sponsor ID
- KF 00/002
- Conditions
- Fulminant Hepatic Failure
- Keywords
- ammonia, acute liver failure, brain edema, oxidative metabolism, intracranial pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Jan 2000
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 4 Feb 2009 (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.
Patients with fulminant hepatic failure (FHF) often develop cerebral edema, high intracranial pressure (ICP)that may result in fatal brain damage. The aim in this protocol is to determine if a rise in the brain concentration of glutamate, lactate and pyruvate are involved in development of surges of high ICP in patients with FHF. The study is observatory in nature and also record the influence of any intervention that may e instituted during the course of the critical illness.
Detailed description
Fulminant hepatic failure (FHF) is often complicated by cerebral edema, high intracranial pressure (ICP) and brain death. Accordingly the intracranial pressure is often monitored in such patients in order to be able to institute treatment before high ICP evolves. As routinely done in patients with severe head injury a microdialysis monitoring catheter is also placed under this procedure to measure metabolic changes that are responsible for surges of high ICP. The aim in this descriptive protocol is to determine if a rise in glutamate, lactate and pyruvate concentration in the brain cortex are involved in development of surges of high ICP in patients with FHF. The study is observatory in nature and also record the influence of any intervention during the course of the critical illness.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| liver | – | Procedure: no interventionpatients with acute liver failure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- consecutive patients with fulminant hepatic failure
Key inclusion criteria (1 listed)
- All patients with fulminant hepatic failure
Key exclusion criteria (5 listed)
- Age below 18 years
- Pregnancy
- Not obtained informed consent
- Suspicion of cancer disease
- No pupil reaction to light
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionthe value of the clinical use of microdialysis monitoring of the brain | Procedure or surgery | liver |
Primary outcome
Brain lactate concentration and intracranial hypertension
Time frame: 2013
to determine if brain oxidative metabolism correlates with brain edema and high intracranial pressure
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 27 Oct 2015.
- Background: PubMed 12447856Tofteng F, Jorgensen L, Hansen BA, Ott P, Kondrup J, Larsen FS. Cerebral microdialysis in patients with fulminant hepatic failure. Hepatology. 2002 Dec;36(6):1333-40. doi: 10.1053/jhep.2002.36944.
- Background: PubMed 20800925Bjerring PN, Hauerberg J, Jorgensen L, Frederiksen HJ, Tofteng F, Hansen BA, Larsen FS. Brain hypoxanthine concentration correlates to lactate/pyruvate ratio but not intracranial pressure in patients with acute liver failure. J Hepatol. 2010 Dec;53(6):1054-8. doi: 10.1016/j.jhep.2010.05.032. Epub 2010 Aug 3.
- Background: PubMed 18250976Bjerring PN, Hauerberg J, Frederiksen HJ, Jorgensen L, Hansen BA, Tofteng F, Larsen FS. Cerebral glutamine concentration and lactate-pyruvate ratio in patients with acute liver failure. Neurocrit Care. 2008;9(1):3-7. doi: 10.1007/s12028-008-9060-4.
- Background: PubMed 15959460Tofteng F, Hauerberg J, Hansen BA, Pedersen CB, Jorgensen L, Larsen FS. Persistent arterial hyperammonemia increases the concentration of glutamine and alanine in the brain and correlates with intracranial pressure in patients with fulminant hepatic failure. J Cereb Blood Flow Metab. 2006 Jan;26(1):21-7. doi: 10.1038/sj.jcbfm.9600168.
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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.
Fin Stolze Larsen study chair
Copenhagen University Hospital, Rigshospitalet
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 Fulminant Hepatic Failure, run by Copenhagen University Hospital, Rigshospitalet 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 5 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 27 Oct 2015. 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.
What does the primary outcome measure?
Brain lactate concentration and intracranial hypertension (time frame: 2013). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00836420, which also lists 4 linked publications.
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 27 Oct 2015.