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Characterizing the cerebrovAscular Physiology of Optimal Mean Arterial Pressure Targeted Resuscitation (CAMPHIBIII)

Primary Purpose

Cardiac Arrest

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Multimodal Neuromonitoring
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Cardiac Arrest

Eligibility Criteria

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

Inclusion Criteria:

  • Confirmed cardiac arrest with return of spontaneous circulation > 10 minutes
  • post resuscitation GCS < 9

Exclusion Criteria:

  • concurrent coagulopathy
  • prior history of TBI, intracranial hemorrhage, subarachnoid hemorrhage
  • anticipated cardiac catheterization within next 7 days
  • anticipated or current use of anticoagulants or anit-platelets

Sites / Locations

  • Vancouver General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Internal arm

Arm Description

Outcomes

Primary Outcome Measures

Cerberal blood flow
mls/100g/min

Secondary Outcome Measures

Full Information

First Posted
July 25, 2018
Last Updated
November 2, 2020
Sponsor
University of British Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT03609333
Brief Title
Characterizing the cerebrovAscular Physiology of Optimal Mean Arterial Pressure Targeted Resuscitation
Acronym
CAMPHIBIII
Official Title
Characterizing the cerebrovAscular Physiology of Optimal Mean Arterial Pressure Targeted Resuscitation in Hypoxic Ischemic Brain Injury After Cardiac Arrest
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
November 12, 2016 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
June 30, 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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Hypoxic ischemic brain injury is a devastating illness that occurs after cardiac arrest (the heart stopping) and can yield irreversible brain damage, often leading to death. The mainstay in therapy is to optimize the delivery of oxygen to the brain to help it recover. In patients with traumatic brain injury (similar to HIBI), the investigators are able to optimize oxygen delivery to the brain with the use of wires placed into the brain that sense the pressure and oxygen in the skull to find the ideal blood pressure for each individual patient. This strategy is associated with improved outcomes. The investigators are conducting a prospective study investigating whether the perfusion within proximity to the optimal MAP is associated with improved brain oxygenation and blood flow .

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
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Internal arm
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Multimodal Neuromonitoring
Other Intervention Name(s)
Targeted optimal MAP resuscitation
Intervention Description
Application of multimodal neuromonitoring
Primary Outcome Measure Information:
Title
Cerberal blood flow
Description
mls/100g/min
Time Frame
12 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Confirmed cardiac arrest with return of spontaneous circulation > 10 minutes post resuscitation GCS < 9 Exclusion Criteria: concurrent coagulopathy prior history of TBI, intracranial hemorrhage, subarachnoid hemorrhage anticipated cardiac catheterization within next 7 days anticipated or current use of anticoagulants or anit-platelets
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mypinder Sekhon, MD
Organizational Affiliation
UBC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31789834
Citation
Sekhon MS, Ainslie PN, Menon DK, Thiara SS, Cardim D, Gupta AK, Hoiland RL, Gooderham P, Griesdale DE. Brain Hypoxia Secondary to Diffusion Limitation in Hypoxic Ischemic Brain Injury Postcardiac Arrest. Crit Care Med. 2020 Mar;48(3):378-384. doi: 10.1097/CCM.0000000000004138.
Results Reference
derived
PubMed Identifier
31185256
Citation
Sekhon MS, Griesdale DE, Ainslie PN, Gooderham P, Foster D, Czosnyka M, Robba C, Cardim D. Intracranial pressure and compliance in hypoxic ischemic brain injury patients after cardiac arrest. Resuscitation. 2019 Aug;141:96-103. doi: 10.1016/j.resuscitation.2019.05.036. Epub 2019 Jun 8.
Results Reference
derived

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Characterizing the cerebrovAscular Physiology of Optimal Mean Arterial Pressure Targeted Resuscitation

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