- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04360070
The Application of Ketamine for Sedation in Patients With Cardiac Arrest - - KetCat (KETamine in Cardiac ArresT) Study (KetCat)
January 6, 2023 updated by: George Medvedev, Fraser Health
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.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: George Medvedev, MD
- Phone Number: 604 759 2140
- Email: drmedvedev@shaw.ca
Study Locations
-
-
British Columbia
-
New Westminster, British Columbia, Canada, V3L 3W7
- Recruiting
- Fraser Health Authority - Royal Columbian Hospital
-
Contact:
- Vesna Ivkov, MHSc
- Email: Vesna.Ivkov@fraserhealth.ca
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ketamine Arm
Patients randomized to the ketamine arm will receive ketamine as part of their sedation medications during their cardiac arrest treatment
|
Parenteral General Anesthetic
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
through study completion, an average of 6 months.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 28, 2022
Primary Completion (Anticipated)
December 9, 2023
Study Completion (Anticipated)
December 12, 2023
Study Registration Dates
First Submitted
April 21, 2020
First Submitted That Met QC Criteria
April 22, 2020
First Posted (Actual)
April 24, 2020
Study Record Updates
Last Update Posted (Estimate)
January 10, 2023
Last Update Submitted That Met QC Criteria
January 6, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Nervous System Diseases
- Heart Arrest
- Out-of-Hospital Cardiac Arrest
- Neurologic Manifestations
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Dissociative
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Ketamine
Other Study ID Numbers
- 001 (NavyGHB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Neurologic Manifestations
-
Zurich Regional Health CenterRecruitingNeurologic SymptomsSwitzerland
-
Institut National de la Santé Et de la Recherche...Université Paris Cité; National Agency for Sanitary Safety of the Food of the...Not yet recruitingNeurologic Disorder | Neurologic Symptoms
-
Vestre Viken Ringerike SykehusCompletedTransient Neurologic SymptomsNorway
-
Rehaklinik Zihlschlacht AGRecruiting
-
National Taiwan University HospitalRecruiting
-
Rush University Medical CenterRecruiting
-
Universitair Ziekenhuis BrusselRecruitingNeuromuscular ManifestationsBelgium
-
University of NebraskaTerminatedGait Disorders, NeurologicUnited States
-
The Leeds Teaching Hospitals NHS TrustCompletedGait Disorders, Neurologic
Clinical Trials on Ketamine Hydrochloride
-
Ciusss de L'Est de l'Île de MontréalRecruiting
-
Juvenile Bipolar Research FoundationTerminatedBipolar DisorderUnited States
-
Gil YosipovitchTerminated
-
Rajmonda Nallbani-KomoniUnknownAnalgesic Drug DependenceKosovo
-
National Cancer Institute, EgyptCompleted
-
Cairo UniversityUnknownSeptic Shock | AnesthesiaEgypt
-
The University of Texas Health Science Center,...TerminatedPost Partum DepressionUnited States
-
Lawson Health Research InstituteUnknownBone Fractures | Dislocations
-
University Health Network, TorontoPrincess Margaret Hospital, CanadaCompletedBreast Neoplasms | LymphedemaCanada