Cardiac Arrest, Out-Of-HospitalKetCatNCT04360070
The Application of Ketamine for Sedation in Patients With Cardiac Arrest - - KetCat (KETamine in Cardiac ArresT) Study
A study testing Ketamine Hydrochloride in people with Cardiac Arrest, Out-Of-Hospital and Ketamine, run by Fraser Health at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Cardiac Arrest, Out-Of-Hospital, Ketamine, Neurologic Manifestations
- What is being tested?
- Ketamine Hydrochloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- 28 Feb 2022to 12 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Fraser Health Authority - Royal Columbian Hospital
New Westminster, British Columbia, V3L 3W7
Vesna Ivkov, MHSc, Vesna.Ivkov@fraserhealth.ca
About this study
Official title: The Application of Ketamine for Sedation in Patients With Cardiac Arrest: Feasibility, Safety, and Potential Impact on Neurological Outcomes
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.
- Being tested
- Ketamine Hydrochloride
- Keywords
- Pilot Study, Single-Centre
- Medical subject headings
- Out-of-Hospital Cardiac Arrest, Neurologic Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine HydrochlorideDrug
Parenteral General Anesthetic
| Study group | Role | What they receive |
|---|---|---|
| Ketamine Arm | Experimental | Patients randomized to the ketamine arm will receive ketamine as part of their sedation medications during their cardiac arrest treatment Receives: Drug: Ketamine Hydrochloride |
| Control Arm | No intervention | Patients randomized to the control arm will not receive ketamine as part of their sedation medications during their cardiac arrest treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start28 Feb 2022
- Primary completion9 Dec 2023 (estimated)
- Study completion12 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac Arrest, Out-Of-HospitalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fraser Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, George Medvedev, Fraser Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04360070
- Sponsor's protocol ID
- 001
- Acronym
- KetCat
- Status last verified
- Jan 2023
- First submitted
- 21 Apr 2020
- Last updated
- 10 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vekhova KA, Namiot ED, Jonsson J, Schioth HB. Ketamine and Esketamine in Clinical Trials: FDA-Approved and Emerging Indications, Trial Trends With Putative Mechanistic Explanations. Clin Pharmacol Ther. 2025 Feb;117(2):374-386. doi: 10.1002/cpt.3478. Epub 2024 Oct 20.
PubMed 39428602
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of Ketamine for Sedation in Patients With Cardiac Arrest: Feasibility, Safety, and Potential Impact on Neurological Outcomes
- ClinicalTrials.gov ID
- NCT04360070
- Acronym / sponsor ID
- KetCat / 001
- Keywords
- Pilot Study, Single-Centre
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Fraser HealthUniversity, hospital or other
- Study start
- 28 Feb 2022 (actual)
- Primary completion
- 9 Dec 2023 (estimated)
- Study completion
- 12 Dec 2023 (estimated)
- First posted
- 24 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketamine Arm | Experimental | Drug: Ketamine HydrochloridePatients randomized to the ketamine arm will receive ketamine as part of their sedation medications during their cardiac arrest treatment |
| Control Arm | No intervention | –Patients randomized to the control arm will not receive ketamine as part of their sedation medications during their cardiac arrest treatment. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketamine HydrochlorideParenteral General Anesthetic | Drug | Ketamine Arm |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2023.
- Derived from this study: PubMed 39428602Vekhova KA, Namiot ED, Jonsson J, Schioth HB. Ketamine and Esketamine in Clinical Trials: FDA-Approved and Emerging Indications, Trial Trends With Putative Mechanistic Explanations. Clin Pharmacol Ther. 2025 Feb;117(2):374-386. doi: 10.1002/cpt.3478. Epub 2024 Oct 20.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketamine Hydrochloride in people with Cardiac Arrest, Out-Of-Hospital and Ketamine, run by Fraser Health at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact George Medvedev, MD (604 759 2140, drmedvedev@shaw.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility Data (time frame: through study completion, an average of 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04360070, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2023.