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

Traumatic Brain Injury Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03246607
• Other study ID #: NCCUGLUC/8817
• Status: Not yet recruiting
• Start date: January 26, 2020
• Est. completion date: October 1, 2020

Study information

• Verified date: July 2019
• Source: Cambridge University Hospitals NHS Foundation Trust
• Contact: Andrew R Stevens, MBChB
• Phone: +44 7577 301242
• Email: a.stevens[@]doctors.org.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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After a brief period of probe stabilisation, 2 ml of blood will be withdrawn for blood gas analysis (including glucose), and the probe readings will be calibrated against this value.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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: October 1, 2020
• Est. primary completion date: August 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

1. Aged 16 and over

2. New episode of acquired brain injury, of any form to include haemorrhage, trauma, infarction

3. Their condition necessitates admission to and care on neurocritical care

4. Their condition necessitates intracerebral microdialysis probe insertion

5. Their condition necessitates arterial line insertion/central venous access and regular/venous blood gas sampling.

Exclusion Criteria:

1. Refusal or withdrawal of consultee agreement and any known patient wishes precluding inclusion.

2. Pregnancy.

3. Peripheral venous cannulation clinically contraindicated.

4. Patients already enrolled in three or more other research studies.

Related Conditions & MeSH terms

• Acquired Brain Injury
• Brain Injuries
• Brain Injuries, Traumatic
• Cerebral Hemorrhage
• Hemorrhage
• Intracerebral Hemorrhage
• Ischemic Stroke
• Subarachnoid Hemorrhage
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Cambridge University Hospitals NHS Foundation Trust	Cambridge	Cambridgeshire

Sponsors (2)

Lead Sponsor	Collaborator
Dr Andrew Stevens	Probe Scientific Limited

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Continuously measured intravascular glucose concentration	Study inserted microdialysis catheter for collection of data on the concentration of glucose in this space.	72 hours
Secondary	Intermittently measured intravascular glucose concentration	Routinely collected data on the concentration of glucose in this space at specific time points.	72 hours
Secondary	Cerebral extracellular fluid glucose concentration	Routinely inserted microdialysis catheter for collection of data on the concentration of glucose in this space.	72 hours