Traumatic Brain InjuryNCT03246607
Venous and Cerebral Glucose Microdialysis in Neurocritical Care: Validation & Correlation
An observational study of Traumatic Brain Injury and Acquired Brain Injury, run by Dr Andrew Stevens at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Traumatic Brain Injury, Acquired Brain Injury, Intracerebral Hemorrhage
- What is being tested?
- MicroEye & ContinuMon
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Jan 2020to 1 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who are admitted to the Neurocritical Care Unit with a severe acquired brain injury
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Cambridge University Hospitals NHS Foundation Trust
Cambridge, Cambridgeshire, CB2 0QQ
Andrew Stevens, MBChB, +44 7577301242, a.stevens@doctors.org.uk
About this study
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
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.
Read the 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.
- Conditions
- Traumatic Brain Injury, Acquired Brain Injury, Intracerebral Hemorrhage, Subarachnoid Hemorrhage, Ischemic Stroke
- Being tested
- MicroEye & ContinuMon
- Medical subject headings
- Brain Injuries, Traumatic, Brain Injuries, Cerebral Hemorrhage, Subarachnoid Hemorrhage, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicroEye & ContinuMonDevice
Continuous intravascular glucose monitoring using MicroEye/ContinuMon system, peripherally inserted via a peripheral venous catheter.
| Study group | Role | What they receive |
|---|---|---|
| Monitoring with MicroEye & ContinuMon | 72 hour study interval with monitoring using intravascular glucose monitoring system alongside routine clinical care. Receives: Device: MicroEye & ContinuMon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Continuously measured intravascular glucose concentration
Study inserted microdialysis catheter for collection of data on the concentration of glucose in this space.
Measured: 72 hours
Secondary outcomes (2)
Intermittently measured intravascular glucose concentration
Routinely collected data on the concentration of glucose in this space at specific time points.
Measured: 72 hours
Cerebral extracellular fluid glucose concentration
Routinely inserted microdialysis catheter for collection of data on the concentration of glucose in this space.
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2017
- Study start26 Jan 2020 (estimated)
- Primary completion2 Aug 2020 (estimated)
- Study completion1 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr Andrew Stevens
- Sponsor type
- University, hospital or other
- Collaborators
- Probe Scientific Limited
- Responsible party
- Sponsor-investigator, Dr Andrew Stevens, Cambridge University Hospitals NHS Foundation Trust
- Investigators
- Ari Ercole, PhD, Principal investigator, Lecturer and Consultant AnaesthetistPeter Hutchinson, PhD, Principal investigator, NIHR Research Professor at the Department of Clinical Neurosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03246607
- Sponsor's protocol ID
- NCCUGLUC/8817
- Status last verified
- Jul 2019
- First submitted
- 9 Aug 2017
- Last updated
- 2 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03246607
- Acronym / sponsor ID
- NCCUGLUC/8817
- Conditions
- Traumatic Brain Injury, Acquired Brain Injury, Intracerebral Hemorrhage, Subarachnoid Hemorrhage, Ischemic Stroke
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Dr Andrew StevensUniversity, hospital or other
- Collaborators
- Probe Scientific Limited
- Study start
- 26 Jan 2020 (estimated)
- Primary completion
- 2 Aug 2020 (estimated)
- Study completion
- 1 Oct 2020 (estimated)
- First posted
- 11 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Monitoring with MicroEye & ContinuMon | – | Device: MicroEye & ContinuMon72 hour study interval with monitoring using intravascular glucose monitoring system alongside routine clinical care. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who are admitted to the Neurocritical Care Unit with a severe acquired brain injury
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MicroEye & ContinuMonContinuous intravascular glucose monitoring using MicroEye/ContinuMon system, peripherally inserted via a peripheral venous catheter. | Device | Monitoring with MicroEye & ContinuMon |
Primary outcome
Continuously measured intravascular glucose concentration
Time frame: 72 hours
Study inserted microdialysis catheter for collection of data on the concentration of glucose in this space.
2 secondary outcomes
Intermittently measured intravascular glucose concentration
Time frame: 72 hours
Cerebral extracellular fluid glucose concentration
Time frame: 72 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ari Ercole, PhD principal investigator
Lecturer and Consultant Anaesthetist
Peter Hutchinson, PhD principal investigator
NIHR Research Professor at the Department of Clinical Neurosciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury and Acquired Brain Injury, run by Dr Andrew Stevens at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrew R Stevens, MBChB (+44 7577 301242, a.stevens@doctors.org.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Continuously measured intravascular glucose concentration (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2019.