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Targeting the Optimal Mean Arterial Pressure in Hypoxic Ischemic Brain Injury After Cardiac Arrest (CAMPING)

Primary Purpose

Cardiac Arrest

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Individualized perfusion targets
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Arrest

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • We will include any patient 19 years or older who are admitted to the ICU following cardiac arrest with a post-resuscitation Glasgow Coma Scale of 8 or less.

    • Existing arterial line in situ as part of their clinical care.
    • Enrolled within 72 hours of their cardiac arrest
    • Patients must have had more than 20 consecutive minutes of spontaneous circulation following resuscitation
    • Duration of cardiac arrest greater than 10 minutes prior to return of spontaneous circulation. This is to ensure that we will not be placing intra-parenchymal bolts in patients who are likely to have a favourable neurological outcome regardless of monitoring.

Exclusion Criteria:

  1. Coagulopathy (INR > 1.5, PTT > 40, Platelets < 100)
  2. Cardiac catheterization procedure is anticipated within the next 7 days.
  3. Current or anticipated use of anticoagulant or antiplatelet medication. Importantly, subcutaneous heparin or dalteparin for deep venous thrombosis prophylaxis may be used provided it is not administered 12 hours prior to insertion or removal of the bolt. This practice is currently utilized in our TBI population.
  4. Undergoing therapeutic hypothermia with a target temperature under 35oC.
  5. Known or prior history of severe TBI, intracranial hemorrhage or stroke that would interfere with cerebral oximetry (i.e. significant prior damage to the frontal lobes).
  6. No current commitment to ongoing support by the medical team

  7. Acute ST elevation myocardial infarction

    -

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Group A

    Group B

    Arm Description

    Individualized care

    Conventional care

    Outcomes

    Primary Outcome Measures

    Cerebral blood flow
    mls/100g/min

    Secondary Outcome Measures

    Full Information

    First Posted
    September 4, 2019
    Last Updated
    November 2, 2020
    Sponsor
    University of British Columbia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04081506
    Brief Title
    Targeting the Optimal Mean Arterial Pressure in Hypoxic Ischemic Brain Injury After Cardiac Arrest
    Acronym
    CAMPING
    Official Title
    Targeting the Optimal Mean Arterial Pressure in Hypoxic Ischemic Brain Injury After Cardiac Arrest
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2020
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    COVID-19 pandemic
    Study Start Date
    October 1, 2019 (Actual)
    Primary Completion Date
    October 1, 2020 (Actual)
    Study Completion Date
    October 1, 2020 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of British Columbia

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Hypoxic ischemic brain injury (HIBI) is the ensuing brain injury after cardiac arrest and is the primary cause of adverse outcome. HIBI is caused by low oxygen delivery to the brain. The patient's blood pressure is primary determinant of oxygen delivery to the brain. International guidelines recommend maintaining uniform blood pressure targets in all patients, however, this 'one size fits all approach' fails to account for individual baseline differences between patient's blood pressures and extent of underlying disease. Recently, 'autoregulation monitoring', a novel brain monitoring technique, has emerged as a viable tool to identify patient specific blood pressures after brain injury. This personalized medicine approach of targeting patient specific blood pressure (MAPopt) is associated with improved outcome in traumatic brain injury. It has not been evaluated in HIBI after cardiac arrest. Recently, I completed a first-in-human study demonstrating the ability to identify MAPopt in HIBI patients using neuromonitoring (microcatheters inserted into the brain tissue). The proposed study in this grant is to take the next step and investigate the changes in key brain physiologic variables (brain blood flow and oxygenation) before and after therapeutically targeting MAPopt in HIBI patients. This interventional study will serve as the basis to embark on a pilot randomized control trial of MAPopt targeted therapy versus standard of care in HIBI patients after cardiac arrest.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cardiac Arrest

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group A
    Arm Type
    Experimental
    Arm Description
    Individualized care
    Arm Title
    Group B
    Arm Type
    No Intervention
    Arm Description
    Conventional care
    Intervention Type
    Other
    Intervention Name(s)
    Individualized perfusion targets
    Intervention Description
    Targeting +/-5mmHg of the optimal mean arterial pressure
    Primary Outcome Measure Information:
    Title
    Cerebral blood flow
    Description
    mls/100g/min
    Time Frame
    6 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: We will include any patient 19 years or older who are admitted to the ICU following cardiac arrest with a post-resuscitation Glasgow Coma Scale of 8 or less. Existing arterial line in situ as part of their clinical care. Enrolled within 72 hours of their cardiac arrest Patients must have had more than 20 consecutive minutes of spontaneous circulation following resuscitation Duration of cardiac arrest greater than 10 minutes prior to return of spontaneous circulation. This is to ensure that we will not be placing intra-parenchymal bolts in patients who are likely to have a favourable neurological outcome regardless of monitoring. Exclusion Criteria: Coagulopathy (INR > 1.5, PTT > 40, Platelets < 100) Cardiac catheterization procedure is anticipated within the next 7 days. Current or anticipated use of anticoagulant or antiplatelet medication. Importantly, subcutaneous heparin or dalteparin for deep venous thrombosis prophylaxis may be used provided it is not administered 12 hours prior to insertion or removal of the bolt. This practice is currently utilized in our TBI population. Undergoing therapeutic hypothermia with a target temperature under 35oC. Known or prior history of severe TBI, intracranial hemorrhage or stroke that would interfere with cerebral oximetry (i.e. significant prior damage to the frontal lobes). No current commitment to ongoing support by the medical team Acute ST elevation myocardial infarction -

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Targeting the Optimal Mean Arterial Pressure in Hypoxic Ischemic Brain Injury After Cardiac Arrest

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