Ketamine for Cardiac Arrest

(KetCat Trial)

Overseen By George Medvedev, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Fraser Health

Disqualifiers: Neurological deficit, ECMO, pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Immediate during cardiac arrest treatment

24 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing whether ketamine, a common sedative, can help improve brain function in people who have had a cardiac arrest. The goal is to see if ketamine can reduce the damage caused by lack of oxygen to the brain during cardiac arrest. Ketamine has been studied for its potential to protect the brain and improve outcomes after cardiac arrest.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is ketamine generally safe for use in humans?

Ketamine can cause side effects like dissociation (feeling disconnected from reality) and increased blood pressure and heart rate. Long-term abuse may harm the heart, but in controlled settings, it is often used safely for anesthesia and psychiatric treatments. ^{1 2 3 4 5}

How is the drug ketamine different from other treatments for cardiac arrest?

Ketamine is unique because it stimulates the cardiovascular system while also providing pain relief without causing total nervous system depression, which is different from many other anesthetics that can depress the entire nervous system. ^{4 6 7 8 9}

Eligibility Criteria

Inclusion Criteria

Over 19 years of age

Patients requiring sedation based on the assessment of the resuscitating physician.

If you have a specific kind of heart rhythm problem called "shockable rhythm" and are being treated at Royal Columbian Hospital for a cardiac arrest, you can participate in the study.

Exclusion Criteria

Your heart stopped for more than 30 minutes without restarting.

You have a known allergy or sensitivity to ketamine.

Any other kind of sudden heart stopping.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ketamine as part of their sedation medications during cardiac arrest treatment

Immediate during cardiac arrest treatment

Follow-up

Participants are monitored for neurological outcomes and safety after treatment

6 months

Treatment Details

Interventions

• Ketamine Hydrochloride

Participant Groups

Group I: Ketamine Arm Experimental Treatment 1 Intervention

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

Group II: Control Arm Active Control 1 Intervention

Patients randomized to the control arm will not receive ketamine as part of their sedation medications during their cardiac arrest treatment.

Ketamine Hydrochloride is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Ketalar for:

• Anesthesia
• Pain management
• Depression
• Suicidal ideation

Approved in European Union as Ketamine Hydrochloride for:

• Anesthesia
• Pain management
• Treatment-resistant depression

Approved in Canada as Ketamine Hydrochloride for:

• Anesthesia
• Pain management
• Depression

Who Is Running the Clinical Trial?

Fraser Health

Lead Sponsor

Trials

49

Recruited

708,000+

Findings from Research

An extended release oral ketamine tablet was found to be safe and well tolerated in a study of seven patients with treatment-resistant depression/anxiety, with no significant changes in vital signs and only one brief report of dissociation.

All patients experienced over 50% improvements in mood ratings over 96 hours, suggesting that while the onset of mood improvement is slightly delayed compared to injectable forms, this oral formulation could be a promising option for treating resistant depression and anxiety disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of extended release ketamine tablets in patients with treatment-resistant depression and anxiety: open label pilot study. Glue, P., Medlicott, NJ., Neehoff, S., et al.[2022]

In a systematic review of 93 studies involving 3756 participants receiving sub-anesthetic doses of ketamine for psychiatric disorders, only four serious adverse medical events (MSAEs) were reported, resulting in an incidence of approximately 0.1%, indicating a very low risk of serious complications.

No serious cardiac events or deaths were observed, and most studies effectively screened out high-risk patients, suggesting that with proper medical screening, ketamine can be administered safely for psychiatric treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of the incidence of medical serious adverse events in sub-anesthetic ketamine treatment of psychiatric disorders. Hovda, N., Gerrish, W., Frizzell, W., et al.[2023]

Ketamine hydrochloride (50mg/ml) remains chemically stable for up to 180 days when stored in polypropylene syringes at room temperature, making it suitable for advance preparation.

The study confirmed that the concentration of ketamine does not fall below 90% of its initial value during this period, ensuring its efficacy for use as an anesthetic agent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term stability of ketamine hydrochloride 50mg/ml injection in 3ml syringes. Huvelle, S., Godet, M., Hecq, JD., et al.[2022]

A retrospective analysis of 449 administrations of ketamine by critical care paramedics showed that it is safely used for trauma, primarily for lower limb injuries, with median doses aligning with national guidelines.

Reported side effects were consistent with known frequencies, indicating that ketamine can be administered safely in a pre-hospital setting, although further prospective studies are needed to confirm its efficacy and safety in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A retrospective analysis of ketamine administration by critical care paramedics in a pre-hospital care setting. Cowley, A., Williams, J., Westhead, P., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Safety and efficacy of extended release ketamine tablets in patients with treatment-resistant depression and anxiety: open label pilot study. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

A systematic review of the incidence of medical serious adverse events in sub-anesthetic ketamine treatment of psychiatric disorders. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Ketamine-induced ventricular structural, sympathetic and electrophysiological remodelling: pathological consequences and protective effects of metoprolol. [2021]

4. France pubmed.ncbi.nlm.nih.gov

Long-term stability of ketamine hydrochloride 50mg/ml injection in 3ml syringes. [2022]

5. England pubmed.ncbi.nlm.nih.gov

A retrospective analysis of ketamine administration by critical care paramedics in a pre-hospital care setting. [2022]

6. Zambia pubmed.ncbi.nlm.nih.gov

Ketalar its use by a single operator. [2013]

7. Germany pubmed.ncbi.nlm.nih.gov

[Use of ketamine in cardiac surgery. A preliminary report]. [2013]

8. Italy pubmed.ncbi.nlm.nih.gov

[Ketamine hydrochloride by continuous drip intravenous infusion in thoracic surgery]. [2013]

9. United States pubmed.ncbi.nlm.nih.gov

Anesthetic and hemodynamic effects of ketamine hydrochloride in buffalo calves (Bubalus bubalis). [2013]