Cerebral Microdialysis in Patients With Fulminant Hepatic Failure
1 other identifier
observational
50
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2000
Longer than P75 for all trials
1 active site
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
Study Start
First participant enrolled
January 1, 2000
CompletedFirst Submitted
Initial submission to the registry
February 3, 2009
CompletedFirst Posted
Study publicly available on registry
February 4, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedOctober 27, 2015
October 1, 2015
15.8 years
February 3, 2009
October 26, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Brain lactate concentration and intracranial hypertension
to determine if brain oxidative metabolism correlates with brain edema and high intracranial pressure
2013
Study Arms (1)
liver
patients with acute liver failure
Interventions
Eligibility Criteria
consecutive patients with fulminant hepatic failure
You may qualify if:
- All patients with fulminant hepatic failure
You may not qualify if:
- Age below 18 years
- Pregnancy
- Not obtained informed consent
- Suspicion of cancer disease
- No pupil reaction to light
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rigshospitalet Dept Hepatology A-2121
Copenhagen, 2100, Denmark
Related Publications (4)
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.
PMID: 12447856BACKGROUNDBjerring 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.
PMID: 20800925BACKGROUNDBjerring 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.
PMID: 18250976BACKGROUNDTofteng 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.
PMID: 15959460BACKGROUND
Biospecimen
microdialysate from the brain as part of rutine monitoring
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Fin Stolze Larsen
Rigshospitalet, Denmark
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- consultant
Study Record Dates
First Submitted
February 3, 2009
First Posted
February 4, 2009
Study Start
January 1, 2000
Primary Completion
October 1, 2015
Study Completion
October 1, 2015
Last Updated
October 27, 2015
Record last verified: 2015-10