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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether ketamine, an anesthetic, can reduce brain damage after cardiac arrest. When the heart stops, the brain suffers from a lack of oxygen, triggering harmful processes. The study will determine if ketamine used during sedation improves brain function. Individuals who have experienced a cardiac arrest outside the hospital and require sedation might be suitable for this trial. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research that could improve outcomes for future cardiac arrest patients.

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 there any evidence suggesting that ketamine is likely to be safe for humans?

A previous study administered ketamine to patients with severe injuries and found no worse survival or disability outcomes, even among those more severely injured. This suggests ketamine can be safely used in challenging situations.

However, concerns exist about ketamine's effects on the heart. One report found that ketamine decreased heart function, which could be problematic, especially for those with existing heart conditions. Another study mentioned the potential for stress-related heart issues, such as problems with the heart muscle.

Overall, while ketamine has shown safety in various situations, considering its potential heart-related side effects is important, particularly for patients with heart issues. Always discuss participation in a trial with healthcare providers. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using ketamine for cardiac arrest because it offers a unique approach compared to standard treatments such as epinephrine or defibrillation. Ketamine is known for its rapid-acting anesthetic and sedative properties, which can help stabilize patients during cardiac arrest by providing sedation and potentially reducing harmful brain activity. Unlike traditional treatments that focus primarily on restoring heart rhythm, ketamine's mechanism could help protect the brain and improve neurological outcomes after resuscitation. This dual action, addressing both heart and brain health, is what makes ketamine an intriguing option for researchers and clinicians.

What evidence suggests that ketamine might be an effective treatment for cardiac arrest?

Research suggests that ketamine, which participants in this trial may receive, might help protect the brain after a heart attack. Ketamine may halt harmful processes in the brain triggered by oxygen deprivation. Studies have shown that using ketamine after a heart attack could improve brain function. Although more research is needed, these early findings offer promise for those considering this treatment. ^{3 4 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Ketamine Hydrochloride

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9804040/

The use of ketamine as a neuroprotective agent following ...

... ketamine following cardiac arrest may result in improved neurologic outcomes. Future research directions should focus on the use of ketamine ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/36184822/

The use of ketamine as a neuroprotective agent following ...

The current state of the literature is reflective of the notion that the use of ketamine following cardiac arrest may result in improved neurologic outcomes.

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04360070

NCT04360070 | The Application of Ketamine for Sedation ...

The investigators hypothesize that patients who receive ketamine as part of their standard sedation procedures during cardiac arrest treatment have better ...

4.

ahajournals.org

ahajournals.org/doi/10.1161/circ.150.suppl_1.4145408

A Case of Ketamine-Induced Stress Cardiomyopathy ...

Ketamine-induced catecholaminergic surge can lead to myocardial stunning with transient ischemia and subsequent reversible heart failure.

5.

accjournal.org

accjournal.org/journal/view.php?number=1519

The impact of ketamine on outcomes in critically ill patients

In a 40-patient retrospective study [13], low-dose (5 µg/kg/min) ketamine reduced opioid consumption in MV adult patients. In cardiac surgery ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11309261/

Outcomes and physiologic responses associated with ...

Ketamine administration was not associated with worse survival or disability despite being administered to more severely injured subjects.

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11152225/

Ketamine Induced Acute Systolic Heart Failure - PMC

Christ et al. reported that patients receiving ketamine infusion had a decrease in the cardiac index by 21% (p=0.01). Another study stated that ...

8.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0735675723007271

Ketamine's love story with the heart: A Takotsubo twist

Ketamine's sympathomimetic effects could theoretically induce stress-related cardiac dysfunction, including cardiomyopathy.