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The Application of Ketamine for Sedation in Patients With Cardiac Arrest

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ClinicalTrials.gov Identifier: NCT04360070
Recruitment Status : Not yet recruiting
First Posted : April 24, 2020
Last Update Posted : July 7, 2020
Sponsor:
Information provided by (Responsible Party):
George Medvedev, Fraser Health

Tracking Information
First Submitted Date  ICMJE April 21, 2020
First Posted Date  ICMJE April 24, 2020
Last Update Posted Date July 7, 2020
Estimated Study Start Date  ICMJE August 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 22, 2020)
Feasibility Data [ Time Frame: through study completion, an average of 6 months. ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Application of Ketamine for Sedation in Patients With Cardiac Arrest
Official Title  ICMJE The Application of Ketamine for Sedation in Patients With Cardiac Arrest: Feasibility, Safety, and Potential Impact on Neurological Outcomes
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Cardiac Arrest, Out-Of-Hospital
  • Ketamine
  • Neurologic Manifestations
Intervention  ICMJE Drug: Ketamine Hydrochloride
Parenteral General Anesthetic
Study Arms  ICMJE
  • Experimental: Ketamine Arm
    Patients randomized to the ketamine arm will receive ketamine as part of their sedation medications during their cardiac arrest treatment
    Intervention: Drug: Ketamine Hydrochloride
  • No Intervention: Control Arm
    Patients randomized to the control arm will not receive ketamine as part of their sedation medications during their cardiac arrest treatment.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 22, 2020)
24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: George Medvedev, MD 604 759 2140 drmedvedev@shaw.ca
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04360070
Other Study ID Numbers  ICMJE 001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party George Medvedev, Fraser Health
Study Sponsor  ICMJE Fraser Health
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Fraser Health
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP