The Application of Ketamine for Sedation in Patients With Cardiac Arrest - - KetCat (KETamine in Cardiac ArresT) Study

Neurologic Manifestations Clinical Trial

— KetCat  

Official title:

The Application of Ketamine for Sedation in Patients With Cardiac Arrest: Feasibility, Safety, and Potential Impact on Neurological Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04360070
• Other study ID #: 001
• Status: Recruiting
• Phase: N/A
• Start date: February 28, 2022
• Est. completion date: December 12, 2023

Study information

• Verified date: January 2023
• Source: Fraser Health
• Contact: George Medvedev, MD
• Phone: 604 759 2140
• Email: drmedvedev[@]shaw.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: December 12, 2023
• Est. primary completion date: December 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Arrest, Out-Of-Hospital
• Heart Arrest
• Ketamine
• Neurologic Manifestations
• Out-of-Hospital Cardiac Arrest

Intervention

Drug:
• Ketamine Hydrochloride
Parenteral General Anesthetic

Locations

Country	Name	City	State
Canada	Fraser Health Authority - Royal Columbian Hospital	New Westminster	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Fraser Health

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.