Cerebral Microdialysis in Patients With Fulminant Hepatic Failure
October 26, 2015 updated by: Dr. Fin Stolze Larsen, Rigshospitalet, Denmark
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Copenhagen, Denmark, 2100
- Rigshospitalet Dept Hepatology A-2121
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
consecutive patients with fulminant hepatic failure
Description
Inclusion Criteria:
- All patients with fulminant hepatic failure
Exclusion Criteria:
- Age below 18 years
- Pregnancy
- Not obtained informed consent
- Suspicion of cancer disease
- No pupil reaction to light
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
liver
patients with acute liver failure
|
the value of the clinical use of microdialysis monitoring of the brain
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Brain lactate concentration and intracranial hypertension
Time Frame: 2013
|
to determine if brain oxidative metabolism correlates with brain edema and high intracranial pressure
|
2013
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Fin Stolze Larsen, Rigshospitalet, Denmark
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Bjerring 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.
- Bjerring 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.
- Tofteng 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2000
Primary Completion (Actual)
October 1, 2015
Study Completion (Actual)
October 1, 2015
Study Registration Dates
First Submitted
February 3, 2009
First Submitted That Met QC Criteria
February 3, 2009
First Posted (Estimate)
February 4, 2009
Study Record Updates
Last Update Posted (Estimate)
October 27, 2015
Last Update Submitted That Met QC Criteria
October 26, 2015
Last Verified
October 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KF 00/002
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