<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03246607</url>
  </required_header>
  <id_info>
    <org_study_id>NCCUGLUC/8817</org_study_id>
    <nct_id>NCT03246607</nct_id>
  </id_info>
  <brief_title>Venous and Cerebral Glucose Microdialysis in Neurocritical Care: Validation &amp; Correlation</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dr Andrew Stevens</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Probe Scientific Limited</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Cambridge University Hospitals NHS Foundation Trust</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the validity of an intravascular continuous glucose monitoring&#xD;
      microdialysis probe, and compares the values to routinely inserted cerebral glucose&#xD;
      microdialysis to evaluate the hypothesised relationship between intracranial and&#xD;
      intravascular glucose levels.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All recruited patients will in any case have probes inserted in theatre for brain tissue&#xD;
      glucose monitoring as a part of their standard clinical care. Probes will be allowed to&#xD;
      stabilize following insertion as is standard clinical practice. A peripheral venous catheter&#xD;
      will be inserted by the study team to allow introduction of the intravascular microdialysis&#xD;
      probe. This will be attached to a regular infusion pump set at 3ml/hr and normal saline, to&#xD;
      produce the microdialysate. The efflux of microdialysate will be connected to the biosensor,&#xD;
      and once passed over the biosensor the subsequent dialysate will be destroyed. A risk&#xD;
      assessment will be made on the basis of the patient's coagulation status and concurrent&#xD;
      venous thromboembolism prophylaxis, and if necessary, low dose low molecular weight heparin&#xD;
      will be included in the saline infusion to ameliorate risk of local thrombosis in the device.&#xD;
      This has a local effect only and does not produce systemic anticoagulation.&#xD;
&#xD;
      After a brief period of probe stabilisation, 2 ml of blood will be withdrawn for blood gas&#xD;
      analysis (including glucose), and the probe readings will be calibrated against this value.&#xD;
      Subsequent calibration will take place 6 hours later, and then at 12 hourly intervals. A&#xD;
      maximum total of 30ml of blood will be required for each patient for blood oxygen content&#xD;
      analysis. Clinically necessitated blood sampling for blood gases will continue, and these&#xD;
      values will be collected post-hoc from our E-hospital clinical records system.&#xD;
&#xD;
      Further data will be collected post-hoc via e-Hospital clinical records system, including:&#xD;
      routinely recorded measures of cerebral extracellular fluid glucose concentration,&#xD;
      physiological parameters (central venous pressure, mean arterial pressure, intracranial&#xD;
      pressure etc), timing and detail of interventions as determined appropriate by routine&#xD;
      clinical decision making.&#xD;
&#xD;
      The study will terminate at 72 hours, whereupon the device will be detached and the&#xD;
      peripheral venous catheter will be removed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 26, 2020</start_date>
  <completion_date type="Anticipated">October 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">August 2, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Continuously measured intravascular glucose concentration</measure>
    <time_frame>72 hours</time_frame>
    <description>Study inserted microdialysis catheter for collection of data on the concentration of glucose in this space.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Intermittently measured intravascular glucose concentration</measure>
    <time_frame>72 hours</time_frame>
    <description>Routinely collected data on the concentration of glucose in this space at specific time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cerebral extracellular fluid glucose concentration</measure>
    <time_frame>72 hours</time_frame>
    <description>Routinely inserted microdialysis catheter for collection of data on the concentration of glucose in this space.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Traumatic Brain Injury</condition>
  <condition>Acquired Brain Injury</condition>
  <condition>Intracerebral Hemorrhage</condition>
  <condition>Subarachnoid Hemorrhage</condition>
  <condition>Ischemic Stroke</condition>
  <arm_group>
    <arm_group_label>Monitoring with MicroEye &amp; ContinuMon</arm_group_label>
    <description>72 hour study interval with monitoring using intravascular glucose monitoring system alongside routine clinical care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MicroEye &amp; ContinuMon</intervention_name>
    <description>Continuous intravascular glucose monitoring using MicroEye/ContinuMon system, peripherally inserted via a peripheral venous catheter.</description>
    <arm_group_label>Monitoring with MicroEye &amp; ContinuMon</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who are admitted to the Neurocritical Care Unit with a severe acquired brain&#xD;
        injury&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Aged 16 and over&#xD;
&#xD;
          2. New episode of acquired brain injury, of any form to include haemorrhage, trauma,&#xD;
             infarction&#xD;
&#xD;
          3. Their condition necessitates admission to and care on neurocritical care&#xD;
&#xD;
          4. Their condition necessitates intracerebral microdialysis probe insertion&#xD;
&#xD;
          5. Their condition necessitates arterial line insertion/central venous access and&#xD;
             regular/venous blood gas sampling.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Refusal or withdrawal of consultee agreement and any known patient wishes precluding&#xD;
             inclusion.&#xD;
&#xD;
          2. Pregnancy.&#xD;
&#xD;
          3. Peripheral venous cannulation clinically contraindicated.&#xD;
&#xD;
          4. Patients already enrolled in three or more other research studies.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ari Ercole, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Lecturer and Consultant Anaesthetist</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Peter Hutchinson, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>NIHR Research Professor at the Department of Clinical Neurosciences</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Andrew R Stevens, MBChB</last_name>
    <phone>+44 7577 301242</phone>
    <email>a.stevens@doctors.org.uk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ari Ercole, PhD</last_name>
    <phone>+44 1223 217 889</phone>
    <email>ae105@cam.ac.uk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Cambridge University Hospitals NHS Foundation Trust</name>
      <address>
        <city>Cambridge</city>
        <state>Cambridgeshire</state>
        <zip>CB2 0QQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <contact>
      <last_name>Andrew Stevens, MBChB</last_name>
      <phone>+44 7577301242</phone>
      <email>a.stevens@doctors.org.uk</email>
    </contact>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>August 9, 2017</study_first_submitted>
  <study_first_submitted_qc>August 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2017</study_first_posted>
  <last_update_submitted>July 1, 2019</last_update_submitted>
  <last_update_submitted_qc>July 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 2, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Cambridge University Hospitals NHS Foundation Trust</investigator_affiliation>
    <investigator_full_name>Dr Andrew Stevens</investigator_full_name>
    <investigator_title>Academic Foundation Doctor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Injuries</mesh_term>
    <mesh_term>Ischemic Stroke</mesh_term>
    <mesh_term>Brain Injuries, Traumatic</mesh_term>
    <mesh_term>Subarachnoid Hemorrhage</mesh_term>
    <mesh_term>Cerebral Hemorrhage</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03246607
org study id: NCCUGLUC/8817
nct id: NCT03246607
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Cohort
time perspective: Prospective
measure: Continuously measured intravascular glucose concentration
time frame: 72 hours
description: Study inserted microdialysis catheter for collection of data on the concentration of glucose in this space.
measure: Intermittently measured intravascular glucose concentration
time frame: 72 hours
description: Routinely collected data on the concentration of glucose in this space at specific time points.
measure: Cerebral extracellular fluid glucose concentration
time frame: 72 hours
description: Routinely inserted microdialysis catheter for collection of data on the concentration of glucose in this space.
arm group label: Monitoring with MicroEye & ContinuMon
description: 72 hour study interval with monitoring using intravascular glucose monitoring system alongside routine clinical care.
intervention type: Device
intervention name: MicroEye & ContinuMon
description: Continuous intravascular glucose monitoring using MicroEye/ContinuMon system, peripherally inserted via a peripheral venous catheter.
arm group label: Monitoring with MicroEye & ContinuMon
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
last name: Ari Ercole, PhD
role: Principal Investigator
affiliation: Lecturer and Consultant Anaesthetist
last name: Peter Hutchinson, PhD
role: Principal Investigator
affiliation: NIHR Research Professor at the Department of Clinical Neurosciences
last name: Andrew R Stevens, MBChB
phone: +44 7577 301242
email: a.stevens@doctors.org.uk
last name: Ari Ercole, PhD
phone: +44 1223 217 889
email: ae105@cam.ac.uk
facility: 
contact: 
country: United Kingdom
responsible party type: Sponsor-Investigator
investigator affiliation: Cambridge University Hospitals NHS Foundation Trust
investigator full name: Dr Andrew Stevens
investigator title: Academic Foundation Doctor
mesh term: Brain Injuries
mesh term: Ischemic Stroke
mesh term: Brain Injuries, Traumatic
mesh term: Subarachnoid Hemorrhage
mesh term: Cerebral Hemorrhage
mesh term: Hemorrhage
mesh term: Wounds and Injuries
sharing ipd: No