Back to resultsThe Application of Ketamine for Sedation in Patients With Cardiac Arrest - - KetCat (KETamine in Cardiac ArresT) Study (KetCat)
Primary Purpose
Cardiac Arrest, Out-Of-Hospital, Ketamine, Neurologic Manifestations
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Ketamine Hydrochloride
Sponsored by
About this trial
This is an interventional prevention trial for Cardiac Arrest, Out-Of-Hospital focused on measuring Pilot Study, Single-Centre
Eligibility Criteria
Inclusion Criteria:
- All out-of-hospital cardiac arrests (OHCA) with a "shockable rhythm" (ventricular fibrillation, pulseless ventricular tachycardia) that present to the Royal Columbian Hospital. The patient may be either in active cardiac arrest with shockable rhythm or may have achieved Return of Spontaneous Circulation (ROSC).
- Over 19 years of age
- Patients requiring sedation based on the assessment of the resuscitating physician.
Exclusion Criteria:
- Any other type of cardiac arrest
- Any history of previous, pre-existing neurological deficit
- Started on Extracorporeal Membrane Oxygenation (ECMO)
- Duration of cardiac arrest without ROSC is greater than 30 consecutive minutes
- Known contraindication or hypersensitivity to ketamine
- Awake patient or no standard sedation or no intubation required
- Inability to obtain deferred consent
- Currently enrolled in any other research study involving drugs or devices
- Patients who are pregnant
- Patients who are prisoners
- Patients residing in Long Term Care (LTC) facilities
Sites / Locations
- Fraser Health Authority - Royal Columbian HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Ketamine Arm
Control Arm
Arm Description
Patients randomized to the ketamine arm will receive ketamine as part of their sedation medications during their cardiac arrest treatment
Patients randomized to the control arm will not receive ketamine as part of their sedation medications during their cardiac arrest treatment.
Outcomes
Primary Outcome Measures
Feasibility Data
To test the appropriateness of the eligibility criteria by recording enrolment rates of eligible patients, test the randomization assignment procedures by evaluating for any difference in baseline characteristics between groups, and test adequate adherence to protocol by recording time taken to administer intervention during sedation procedures.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04360070
Brief Title
The Application of Ketamine for Sedation in Patients With Cardiac Arrest - - KetCat (KETamine in Cardiac ArresT) Study
Acronym
KetCat
Official Title
The Application of Ketamine for Sedation in Patients With Cardiac Arrest: Feasibility, Safety, and Potential Impact on Neurological Outcomes
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 28, 2022 (Actual)
Primary Completion Date
December 9, 2023 (Anticipated)
Study Completion Date
December 12, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fraser Health
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
No
5. Study Description
Brief Summary
Recent evidence suggests ketamine may attenuate harmful cellular cascades taking place after brain injury that result in permanent damage. The investigators are interested in researching the application of this in the setting of cardiac arrest. Following cardiac arrest, the brain is deprived oxygen for a period of time, leading to the imitation of these harmful cellular processes. The investigators hypothesize that patients who receive ketamine as part of their standard sedation procedures during cardiac arrest treatment have better neurological functioning compared to those who do not.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest, Out-Of-Hospital, Ketamine, Neurologic Manifestations
Keywords
Pilot Study, Single-Centre
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ketamine Arm
Arm Type
Experimental
Arm Description
Patients randomized to the ketamine arm will receive ketamine as part of their sedation medications during their cardiac arrest treatment
Arm Title
Control Arm
Arm Type
No Intervention
Arm Description
Patients randomized to the control arm will not receive ketamine as part of their sedation medications during their cardiac arrest treatment.
Intervention Type
Drug
Intervention Name(s)
Ketamine Hydrochloride
Intervention Description
Parenteral General Anesthetic
Primary Outcome Measure Information:
Title
Feasibility Data
Description
To test the appropriateness of the eligibility criteria by recording enrolment rates of eligible patients, test the randomization assignment procedures by evaluating for any difference in baseline characteristics between groups, and test adequate adherence to protocol by recording time taken to administer intervention during sedation procedures.
Time Frame
through study completion, an average of 6 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All out-of-hospital cardiac arrests (OHCA) with a "shockable rhythm" (ventricular fibrillation, pulseless ventricular tachycardia) that present to the Royal Columbian Hospital. The patient may be either in active cardiac arrest with shockable rhythm or may have achieved Return of Spontaneous Circulation (ROSC).
Over 19 years of age
Patients requiring sedation based on the assessment of the resuscitating physician.
Exclusion Criteria:
Any other type of cardiac arrest
Any history of previous, pre-existing neurological deficit
Started on Extracorporeal Membrane Oxygenation (ECMO)
Duration of cardiac arrest without ROSC is greater than 30 consecutive minutes
Known contraindication or hypersensitivity to ketamine
Awake patient or no standard sedation or no intubation required
Inability to obtain deferred consent
Currently enrolled in any other research study involving drugs or devices
Patients who are pregnant
Patients who are prisoners
Patients residing in Long Term Care (LTC) facilities
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
George Medvedev, MD
Phone
604 759 2140
Email
drmedvedev@shaw.ca
Facility Information:
Facility Name
Fraser Health Authority - Royal Columbian Hospital
City
New Westminster
State/Province
British Columbia
ZIP/Postal Code
V3L 3W7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vesna Ivkov, MHSc
Email
Vesna.Ivkov@fraserhealth.ca
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Application of Ketamine for Sedation in Patients With Cardiac Arrest - - KetCat (KETamine in Cardiac ArresT) Study
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