NCT04360070

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 21, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 24, 2020

Completed
1.8 years until next milestone

Study Start

First participant enrolled

February 28, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 9, 2023

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2023

Completed
Last Updated

January 10, 2023

Status Verified

January 1, 2023

Enrollment Period

1.8 years

First QC Date

April 21, 2020

Last Update Submit

January 6, 2023

Conditions

Cardiac Arrest, Out-Of-HospitalKetamineNeurologic Manifestations

Keywords

Pilot StudySingle-Centre

Outcome Measures

Primary Outcomes (1)

  • 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.

    through study completion, an average of 6 months.

Study Arms (2)

Ketamine Arm

EXPERIMENTAL

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

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.

Interventions

Ketamine HydrochlorideDRUG

Parenteral General Anesthetic

Ketamine Arm

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fraser Health Authority - Royal Columbian Hospital

New Westminster, British Columbia, V3L 3W7, Canada

RECRUITING

MeSH Terms

Conditions

Out-of-Hospital Cardiac ArrestNeurologic Manifestations

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Heart ArrestHeart DiseasesCardiovascular DiseasesNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Central Study Contacts

George Medvedev, MD

CONTACT

604 759 2140drmedvedev@shaw.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Neurology

Study Record Dates

First Submitted

April 21, 2020

First Posted

April 24, 2020

Study Start

February 28, 2022

Primary Completion

December 9, 2023

Study Completion

December 12, 2023

Last Updated

January 10, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)