Combined Intracerebral and Jugular Bulb Microdialysis
Continuous Monitoring of Cerebral Metabolic State. Combined Intracerebral and Jugular Bulb Microdialysis in Neurocritical Care.
1 other identifier
observational
12
1 country
1
Brief Summary
The first aim of this study is to investigate the frequency and severity of a specific pathological metabolic pattern, mitochondrial dysfunction, of the brain in comatose patients under neurocritical care. This pattern is recognized as a complication after compromised blood flow to the brain and may be amenable to treatment. The other main aim of this study is to correlate patterns of metabolites between brain and jugular venous blood. It is probable but not proven that jugular venous microdialysis can mirror the global metabolic state of the brain.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Aug 2017
Shorter than P25 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
August 28, 2017
CompletedFirst Submitted
Initial submission to the registry
September 12, 2017
CompletedFirst Posted
Study publicly available on registry
October 19, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2018
CompletedFebruary 28, 2019
February 1, 2019
10 months
September 12, 2017
February 27, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Correlations of lactate/pyruvate-ratio (LP-ratio) calculated by dividing lactate concentration in mM by pyruvate concentration in mikroM, in cerebral and venous microdialysis
Hourly samples of lactate (mM) and pyruvate (mikroM) are assessed using microdialysis measurements in brain and jugular bulb. The LP-ratio is calculated and compared at each timepoint.
Patients are monitored a mean of 5 days with hourly analysis.
Secondary Outcomes (3)
Correlations of microdialysis values of glucose.
Mean 5 day measurements
Modified Rankin scale of outcome.
6 months
Evaluation of mitochondrial dysfunction under study period.
calculations based on mean 5-day measurements per patient.
Eligibility Criteria
Patients admitted to the neurointensive care unit at Odense University Hospital.
You may qualify if:
- Glasgow coma score \<8.
- Suspicion of intracranial pathology
You may not qualify if:
- Suspected and/or Untreated coagulopathy
- Consent from closest of kin not given
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Odense University Hospitallead
- Region of Southern Denmarkcollaborator
Study Sites (1)
Odense University Hospital
Odense, 5000, Denmark
Related Publications (10)
Nordstrom CH, Koskinen LO, Olivecrona M. Aspects on the Physiological and Biochemical Foundations of Neurocritical Care. Front Neurol. 2017 Jun 19;8:274. doi: 10.3389/fneur.2017.00274. eCollection 2017.
PMID: 28674514BACKGROUNDNordstrom CH, Rehncrona S, Siesjo BK. Restitution of cerebral energy state, as well as of glycolytic metabolites, citric acid cycle intermediates and associated amino acids after 30 minutes of complete ischemia in rats anaesthetized with nitrous oxide or phenobarbital. J Neurochem. 1978 Feb;30(2):479-86. doi: 10.1111/j.1471-4159.1978.tb06553.x. No abstract available.
PMID: 624953BACKGROUNDJacobsen A, Nielsen TH, Nilsson O, Schalen W, Nordstrom CH. Bedside diagnosis of mitochondrial dysfunction in aneurysmal subarachnoid hemorrhage. Acta Neurol Scand. 2014 Sep;130(3):156-63. doi: 10.1111/ane.12258. Epub 2014 May 3.
PMID: 24796605BACKGROUNDNielsen TH, Olsen NV, Toft P, Nordstrom CH. Cerebral energy metabolism during mitochondrial dysfunction induced by cyanide in piglets. Acta Anaesthesiol Scand. 2013 Jul;57(6):793-801. doi: 10.1111/aas.12092. Epub 2013 Mar 18.
PMID: 23495747BACKGROUNDNielsen TH, Bindslev TT, Pedersen SM, Toft P, Olsen NV, Nordstrom CH. Cerebral energy metabolism during induced mitochondrial dysfunction. Acta Anaesthesiol Scand. 2013 Feb;57(2):229-35. doi: 10.1111/j.1399-6576.2012.02783.x. Epub 2012 Sep 28.
PMID: 23017022BACKGROUNDPoulsen FR, Schulz M, Jacobsen A, Andersen AB, Larsen L, Schalen W, Nielsen TH, Nordstrom CH. Bedside evaluation of cerebral energy metabolism in severe community-acquired bacterial meningitis. Neurocrit Care. 2015 Apr;22(2):221-8. doi: 10.1007/s12028-014-0057-x.
PMID: 25142826BACKGROUNDSkjoth-Rasmussen J, Schulz M, Kristensen SR, Bjerre P. Delayed neurological deficits detected by an ischemic pattern in the extracellular cerebral metabolites in patients with aneurysmal subarachnoid hemorrhage. J Neurosurg. 2004 Jan;100(1):8-15. doi: 10.3171/jns.2004.100.1.0008.
PMID: 14743906BACKGROUNDRostami E, Engquist H, Howells T, Johnson U, Ronne-Engstrom E, Nilsson P, Hillered L, Lewen A, Enblad P. Early low cerebral blood flow and high cerebral lactate: prediction of delayed cerebral ischemia in subarachnoid hemorrhage. J Neurosurg. 2018 Jun;128(6):1762-1770. doi: 10.3171/2016.11.JNS161140. Epub 2017 Jun 2.
PMID: 28574309BACKGROUNDHutchinson PJ, Jalloh I, Helmy A, Carpenter KL, Rostami E, Bellander BM, Boutelle MG, Chen JW, Claassen J, Dahyot-Fizelier C, Enblad P, Gallagher CN, Helbok R, Hillered L, Le Roux PD, Magnoni S, Mangat HS, Menon DK, Nordstrom CH, O'Phelan KH, Oddo M, Perez Barcena J, Robertson C, Ronne-Engstrom E, Sahuquillo J, Smith M, Stocchetti N, Belli A, Carpenter TA, Coles JP, Czosnyka M, Dizdar N, Goodman JC, Gupta AK, Nielsen TH, Marklund N, Montcriol A, O'Connell MT, Poca MA, Sarrafzadeh A, Shannon RJ, Skjoth-Rasmussen J, Smielewski P, Stover JF, Timofeev I, Vespa P, Zavala E, Ungerstedt U. Consensus statement from the 2014 International Microdialysis Forum. Intensive Care Med. 2015 Sep;41(9):1517-28. doi: 10.1007/s00134-015-3930-y.
PMID: 26194024BACKGROUNDTachtsidis I, Tisdall MM, Pritchard C, Leung TS, Ghosh A, Elwell CE, Smith M. Analysis of the changes in the oxidation of brain tissue cytochrome-c-oxidase in traumatic brain injury patients during hypercapnoea: a broadband NIRS study. Adv Exp Med Biol. 2011;701:9-14. doi: 10.1007/978-1-4419-7756-4_2.
PMID: 21445763BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Frantz Rom Poulsen, MD, PhD
Consultant, Professor, Research leader
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD-fellow
Study Record Dates
First Submitted
September 12, 2017
First Posted
October 19, 2017
Study Start
August 28, 2017
Primary Completion
July 1, 2018
Study Completion
July 1, 2018
Last Updated
February 28, 2019
Record last verified: 2019-02