Recruiting

Ketamine

Sponsor:

Fraser Health

Code:

NCT04360070

Conditions

Cardiac Arrest, Out-Of-Hospital

Ketamine

Neurologic Manifestations

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

Ketamine Hydrochloride

Study Details

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.

Conditions

Cardiac Arrest, Out-Of-Hospital

Ketamine

Neurologic Manifestations

Study ID

NCT04360070

Start date

Feb 28, 2022

Status verified date

Jan, 2023

Completion date

Dec 12, 2023

Anticipated

Primary completion date

Dec 9, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Ketamine Arm

Patients randomized to the ketamine arm will receive ketamine as part of their sedation medications during their cardiac arrest treatment

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.

Interventions

Ketamine Hydrochloride

Parenteral General Anesthetic

Primary outcome measure

  • Feasibility Data [ Time Frame: through study completion, an average of 6 months. ]

Central Contacts and Locations

Central contacts

George Medvedev, MD

604 759 2140drmedvedev@shaw.ca

Locations

Fraser Health Authority - Royal Columbian Hospital

Recruiting

New Westminster, British Columbia, Canada, V3L 3W7

Contacts

Vesna Ivkov, MHSc

Vesna.Ivkov@fraserhealth.ca

More Information

Sponsor

Fraser Health

Last update posted

Jan 10, 2023

Last verified

Jan, 2023

Keywords

  • Pilot Study
  • Single-Centre

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Fraser Health on 2023-01-10.