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

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.

Study Overview

• Status: Unknown
• Conditions: Ischemic Stroke; Traumatic Brain Injury; Subarachnoid Hemorrhage; Acquired Brain Injury; Intracerebral Hemorrhage
• Intervention / Treatment: 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After a brief period of probe stabilisation, 2 ml of blood will be withdrawn for blood gas analysis (including glucose), and the probe readings will be calibrated against this value.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 Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

• Study Contact: Name: Andrew R Stevens, MBChB; Phone Number: +44 7577 301242; Email: a.stevens@doctors.org.uk
• Study Contact Backup: Name: Ari Ercole, PhD; Phone Number: +44 1223 217 889; Email: ae105@cam.ac.uk

Study Locations

• United Kingdom
  • Cambridgeshire
    • Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
      • Cambridge University Hospitals NHS Foundation Trust
      • Contact: Andrew Stevens, MBChB; Phone Number: +44 7577301242; Email: a.stevens@doctors.org.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who are admitted to the Neurocritical Care Unit with a severe acquired brain injury

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Continuously measured intravascular glucose concentration	Study inserted microdialysis catheter for collection of data on the concentration of glucose in this space.	72 hours

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Dr Andrew Stevens
• Collaborators: 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

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 26, 2020
• Primary Completion (ANTICIPATED): August 2, 2020
• Study Completion (ANTICIPATED): October 1, 2020

Study Registration Dates

• First Submitted: August 9, 2017
• First Submitted That Met QC Criteria: August 9, 2017
• First Posted (ACTUAL): August 11, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 2, 2019
• Last Update Submitted That Met QC Criteria: July 1, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Stroke; Intracranial Hemorrhages; Ischemic Stroke; Brain Injuries; Wounds and Injuries; Hemorrhage; Brain Injuries, Traumatic; Subarachnoid Hemorrhage; Cerebral Hemorrhage
• Other Study ID Numbers: NCCUGLUC/8817

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No