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

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ClinicalTrials.gov Identifier: NCT04081506
Recruitment Status : Withdrawn (COVID-19 pandemic)
First Posted : September 9, 2019
Last Update Posted : November 4, 2020
Sponsor:
Information provided by (Responsible Party):
Myp Sekhon, University of British Columbia

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.


Condition or disease Intervention/treatment Phase
Cardiac Arrest Other: Individualized perfusion targets Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Targeting the Optimal Mean Arterial Pressure in Hypoxic Ischemic Brain Injury After Cardiac Arrest
Actual Study Start Date : October 1, 2019
Actual Primary Completion Date : October 1, 2020
Actual Study Completion Date : October 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiac Arrest

Arm Intervention/treatment
Experimental: Group A
Individualized care
Other: Individualized perfusion targets
Targeting +/-5mmHg of the optimal mean arterial pressure

No Intervention: Group B
Conventional care



Primary Outcome Measures :
  1. Cerebral blood flow [ Time Frame: 6 hours ]
    mls/100g/min



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  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

    -

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Responsible Party: Myp Sekhon, Clinical Assistant Professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT04081506    
Other Study ID Numbers: H16-00466-A015
First Posted: September 9, 2019    Key Record Dates
Last Update Posted: November 4, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Additional relevant MeSH terms:
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Brain Injuries
Heart Arrest
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Heart Diseases
Cardiovascular Diseases