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.
The Application of Ketamine for Sedation in Patients With Cardiac Arrest - - KetCat (KETamine in Cardiac ArresT) Study
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.
Condition or Disease
- Cardiac Arrest, Out-Of-Hospital
- Ketamine
- Neurologic Manifestations
Phase
Study Design
| Study type: | INTERVENTIONAL |
|---|---|
| Status: | Recruiting |
| Study results: | No Results Available |
| Age: | 19 Years and older (Adult, Older Adult) |
| Enrollment: | 24 (ESTIMATED) |
| Funded by: | Other |
| Allocation: | Randomized |
| Primary Purpose: | Prevention |
MaskingTRIPLE:
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Clinical Trial Dates
| Start date: | Feb 28, 2022 | ACTUAL |
|---|---|---|
| Primary Completion: | Dec 09, 2023 | ESTIMATED |
| Completion Date: | Dec 12, 2023 | ESTIMATED |
| Study First Posted: | Apr 24, 2020 | ACTUAL |
| Results First Posted: | Aug 31, 2020 | |
| Last Updated: | Jan 06, 2023 |
Sponsors / Collaborators
Lead Sponsor:
Fraser Health
Responsible Party:
N/A
Participant Groups
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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.
Eligibility Criteria
| Sex: | All |
|---|---|
| Minimum Age: | 19 |
| Age Groups: | Adult / Older Adult |
| Healthy Volunteers: | Yes |
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
* 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
This clinical trial is recruiting
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Primary Outcomes
More Details
| NCT Number: | NCT04360070 |
|---|---|
| Other IDs: | 001 |
| Study URL: | https://clinicaltrials.gov/study/NCT04360070 |
Last updated: Sep 29, 2023