Venous and Cerebral Glucose Microdialysis in Neurocritical Care: Validation & Correlation
Investigation of Venous and Cerebral Extracellular Glucose Concentration Relationship Using Continuous Microdialysis, in Acquired Brain Injury in Neurocritical Care, With External Validation of Venous Microdialysis System
1 other identifier
observational
20
1 country
1
Brief Summary
This study evaluates the validity of an intravascular continuous glucose monitoring microdialysis probe, and compares the values to routinely inserted cerebral glucose microdialysis to evaluate the hypothesised relationship between intracranial and intravascular glucose levels.
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 Jan 2020
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
First Submitted
Initial submission to the registry
August 9, 2017
CompletedFirst Posted
Study publicly available on registry
August 11, 2017
CompletedStudy Start
First participant enrolled
January 26, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 2, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2020
CompletedJuly 2, 2019
July 1, 2019
6 months
August 9, 2017
July 1, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Continuously measured intravascular glucose concentration
Study inserted microdialysis catheter for collection of data on the concentration of glucose in this space.
72 hours
Secondary Outcomes (2)
Intermittently measured intravascular glucose concentration
72 hours
Cerebral extracellular fluid glucose concentration
72 hours
Study Arms (1)
Monitoring with MicroEye & ContinuMon
72 hour study interval with monitoring using intravascular glucose monitoring system alongside routine clinical care.
Interventions
Continuous intravascular glucose monitoring using MicroEye/ContinuMon system, peripherally inserted via a peripheral venous catheter.
Eligibility Criteria
Patients who are admitted to the Neurocritical Care Unit with a severe acquired brain injury
You may qualify if:
- Aged 16 and over
- New episode of acquired brain injury, of any form to include haemorrhage, trauma, infarction
- Their condition necessitates admission to and care on neurocritical care
- Their condition necessitates intracerebral microdialysis probe insertion
- Their condition necessitates arterial line insertion/central venous access and regular/venous blood gas sampling.
You may not qualify if:
- Pregnancy.
- Peripheral venous cannulation clinically contraindicated.
- Patients already enrolled in three or more other research studies.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dr Andrew Stevenslead
- Probe Scientific Limitedcollaborator
Study Sites (1)
Cambridge University Hospitals NHS Foundation Trust
Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ari Ercole, PhD
Lecturer and Consultant Anaesthetist
- PRINCIPAL INVESTIGATOR
Peter Hutchinson, PhD
NIHR Research Professor at the Department of Clinical Neurosciences
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Academic Foundation Doctor
Study Record Dates
First Submitted
August 9, 2017
First Posted
August 11, 2017
Study Start
January 26, 2020
Primary Completion
August 2, 2020
Study Completion
October 1, 2020
Last Updated
July 2, 2019
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will not share