Venous and Cerebral Glucose Microdialysis in Neurocritical Care: Validation & Correlation

Sponsor

Dr Andrew Stevens (Other)

Overall Status

Unknown status

CT.gov ID

NCT03246607

Collaborator

Probe Scientific Limited (Industry)

Enrollment

Location

8.2

Anticipated Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Traumatic Brain Injury Acquired Brain Injury Intracerebral Hemorrhage Subarachnoid Hemorrhage Ischemic Stroke	Device: MicroEye & ContinuMon

Detailed Description

All recruited patients will in any case have probes inserted in theatre for brain tissue glucose monitoring as a part of their standard clinical care. Probes will be allowed to stabilize following insertion as is standard clinical practice. A peripheral venous catheter will be inserted by the study team to allow introduction of the intravascular microdialysis probe. This will be attached to a regular infusion pump set at 3ml/hr and normal saline, to produce the microdialysate. The efflux of microdialysate will be connected to the biosensor, and once passed over the biosensor the subsequent dialysate will be destroyed. A risk assessment will be made on the basis of the patient's coagulation status and concurrent venous thromboembolism prophylaxis, and if necessary, low dose low molecular weight heparin will be included in the saline infusion to ameliorate risk of local thrombosis in the device. This has a local effect only and does not produce systemic anticoagulation.

After a brief period of probe stabilisation, 2 ml of blood will be withdrawn for blood gas analysis (including glucose), and the probe readings will be calibrated against this value. Subsequent calibration will take place 6 hours later, and then at 12 hourly intervals. A maximum total of 30ml of blood will be required for each patient for blood oxygen content analysis. Clinically necessitated blood sampling for blood gases will continue, and these values will be collected post-hoc from our E-hospital clinical records system.

Further data will be collected post-hoc via e-Hospital clinical records system, including:

routinely recorded measures of cerebral extracellular fluid glucose concentration, physiological parameters (central venous pressure, mean arterial pressure, intracranial pressure etc), timing and detail of interventions as determined appropriate by routine clinical decision making.

The study will terminate at 72 hours, whereupon the device will be detached and the peripheral venous catheter will be removed.

Study Design

Study Type:

Observational

Anticipated Enrollment :

20 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Jan 26, 2020

Anticipated Primary Completion Date :

Aug 2, 2020

Anticipated Study Completion Date :

Oct 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Monitoring with MicroEye & ContinuMon 72 hour study interval with monitoring using intravascular glucose monitoring system alongside routine clinical care.	Device: MicroEye & ContinuMon Continuous intravascular glucose monitoring using MicroEye/ContinuMon system, peripherally inserted via a peripheral venous catheter.

Arm

Intervention/Treatment

Monitoring with MicroEye & ContinuMon

72 hour study interval with monitoring using intravascular glucose monitoring system alongside routine clinical care.

Device: MicroEye & ContinuMon

Continuous intravascular glucose monitoring using MicroEye/ContinuMon system, peripherally inserted via a peripheral venous catheter.

Outcome Measures

Primary Outcome Measures

Continuously measured intravascular glucose concentration [72 hours]
Study inserted microdialysis catheter for collection of data on the concentration of glucose in this space.

Secondary Outcome Measures

Intermittently measured intravascular glucose concentration [72 hours]
Routinely collected data on the concentration of glucose in this space at specific time points.
Cerebral extracellular fluid glucose concentration [72 hours]
Routinely inserted microdialysis catheter for collection of data on the concentration of glucose in this space.

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

Refusal or withdrawal of consultee agreement and any known patient wishes precluding inclusion.
Pregnancy.
Peripheral venous cannulation clinically contraindicated.
Patients already enrolled in three or more other research studies.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cambridge University Hospitals NHS Foundation Trust	Cambridge	Cambridgeshire	United Kingdom	CB2 0QQ

Sponsors and Collaborators

Dr Andrew Stevens
Probe Scientific Limited

Investigators

Principal Investigator: Ari Ercole, PhD, Lecturer and Consultant Anaesthetist
Principal Investigator: Peter Hutchinson, PhD, NIHR Research Professor at the Department of Clinical Neurosciences