Out-of-hospital Cardiac Arrest (OHCA)Phase 2KETOHCANCT06744361
Ketamine Sedation As Neuroprotective Agent Following Out-of-hospital Cardiac Arrest
A Phase 2 study testing esketamine hydrochloride and propofol in people with Out-of-hospital Cardiac Arrest (OHCA), run by Christian Hassager at 2 sites in Denmark.
Trial summary
OHCA is a critical medical emergency with significant mortality and morbidity primarily due to hypoxic-ischemic brain injury (HIBI). Despite advances in resuscitation techniques, the neurological outcomes for survivors remain poor. Current post-resuscitation practices lack specific neuroprotective strategies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Out-of-hospital Cardiac Arrest (OHCA)
- What is being tested?
- esketamine hydrochloride and propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 282 participants
- Where
- 2 sitesDenmark
- Study dates
- 12 Dec 2024to 1 Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (age ≥18 years) AND
- resuscitated OHCA of presumed cardiac cause with a shockable first recorded heart rhythm AND
- mean arterial pressure (MAP) >40 mmHg AND
- a decision to perform prehospital intubation.
Who cannot join
- Advanced life support termination-of-resuscitation (TOR) criteria met
- Systolic blood pressure >190 mmHg
- Known allergy to ketamine or propofol
- Chronic diseases making 180-day survival unlikely
- Body temperature <30° C.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark2 sites, 2 recruiting
- Recruiting
Department of Cardiology, Rigshospitalet
Copenhagen, 2100
Laust R Obling, MD, +4520404577, laust.obling.01@regionh.dk
Laust R Obling, MD
- Not yet recruiting
Odense University Hospital
Odense C, 5000
Henrik Schmidt, MD, +4529647253, henrik.schmidt@rsyd.dk
Henrik Schmidt, MD
About this study
Official title: KETamine Sedation As Neuroprotective Agent Following Out-of-hospital Cardiac Arrest (OHCA) - the KETOHCA Trial
OHCA is a critical medical emergency with significant mortality and morbidity primarily due to hypoxic-ischemic brain injury (HIBI). Despite advances in resuscitation techniques, the neurological outcomes for survivors remain poor. Current post-resuscitation practices lack specific neuroprotective strategies. Ketamine, an N-Methyl-D-Aspartate (NMDA) receptor antagonist, has shown potential neuroprotective properties in preclinical and clinical studies due to its ability to inhibit excitotoxicity and reduce neuronal apoptosis. This trial hypothesizes that ketamine, when used for sedation in OHCA patients, may offer superior neuroprotective benefits compared to the commonly used sedative propofol. By comparing the effects of ketamine and propofol on neuronal damage markers and long-term neurological outcomes, this study aims to identify a potentially effective intervention to improve the prognosis of OHCA patients.
- Conditions
- Out-of-hospital Cardiac Arrest (OHCA)
- Being tested
- esketamine hydrochloride, propofol
- Medical subject headings
- Out-of-Hospital Cardiac Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
esketamine hydrochlorideDrug
Prehospital intravenous or intraosseous bolus administration at a minimum of 0.5 mg/kg of esketamine
propofolDrug
Prehospital intravenous or intraosseous bolus administration at a minimum dose of 0.25 mg/kg propofol
| Study group | Role | What they receive |
|---|---|---|
| S-ketamin | Experimental | Intravenous or intraosseous bolus administration at a minimum of 0.5 mg/kg of esketamine Receives: Drug: esketamine hydrochloride |
| Propofol | Active comparator | Prehospital intravenous or intraosseous bolus administration of a minimum dose of 0.25 mg/kg propofol Receives: Drug: propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuron-specific enolase (NSE) measured 48 hours after OHCA
To determine the neuroprotective efficacy of ketamine compared with propofol administered as part of sedation for intubation after initial resuscitation from OHCA
Measured: 48 hours after OHCA
Secondary outcomes (7)
Death from any cause
Death from any cause 180 days after cardiac arrest
Measured: 180 days after cardiac arrest
Neurological outcome: modified Rankin Score (mRS)
Neurological outcome by and modified Rankin Score (mRS). Meassured from 0 to 6, where 0 is no symptoms.
Measured: At 2 weeks (at discharge)
Neurological outcome: Cerebral Performance Categories (CPC)
Neurological outcome by Cerebral Performance Categories (CPC) meassured fra 1-5 (a score of 1 is normal/good cerebral function).
Measured: At 2 weeks (at discharge)
Neurological outcome: modified Rankin Score (mRS)
Neurological outcome by and modified Rankin Score (mRS). Meassured from 0 to 6, where 0 is no symptoms.
Measured: At 180 days after OHCA.
Neurological outcome: modified Rankin Score (mRS)
Neurological outcome by and modified Rankin Score (mRS). Meassured from 0 to 6, where 0 is no symptoms.
Measured: At 240 days after OHCA.
Neurological outcome: Cerebral Performance Categories (CPC)
Neurological outcome by Cerebral Performance Categories (CPC) meassured fra 1-5 (a score of 1 is normal/good cerebral function).
Measured: At 180 days after OHCA.
Neurological outcome: Cerebral Performance Categories (CPC)
Neurological outcome by Cerebral Performance Categories (CPC) meassured fra 1-5 (a score of 1 is normal/good cerebral function).
Measured: At 240 days after OHCA.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start12 Dec 2024
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Out-of-hospital Cardiac Arrest (OHCA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 282 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Christian Hassager
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Christian Hassager, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06744361
- Sponsor's protocol ID
- 2024-515987-29-00
- Other IDs
- 2024-515987-29-00
- Acronym
- KETOHCA
- Status last verified
- Dec 2024
- First submitted
- 6 Dec 2024
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- KETamine Sedation As Neuroprotective Agent Following Out-of-hospital Cardiac Arrest (OHCA) - the KETOHCA Trial
- ClinicalTrials.gov ID
- NCT06744361
- Acronym / sponsor ID
- KETOHCA / 2024-515987-29-00
- Conditions
- Out-of-hospital Cardiac Arrest (OHCA)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 282 participants (estimated)
- Lead sponsor
- Christian HassagerUniversity, hospital or other
- Study start
- 12 Dec 2024 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 20 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
OHCA is a critical medical emergency with significant mortality and morbidity primarily due to hypoxic-ischemic brain injury (HIBI). Despite advances in resuscitation techniques, the neurological outcomes for survivors remain poor. Current post-resuscitation practices lack specific neuroprotective strategies. Ketamine, an N-Methyl-D-Aspartate (NMDA) receptor antagonist, has shown potential neuroprotective properties in preclinical and clinical studies due to its ability to inhibit excitotoxicity and reduce neuronal apoptosis. This trial hypothesizes that ketamine, when used for sedation in OHCA patients, may offer superior neuroprotective benefits compared to the commonly used sedative propofol. By comparing the effects of ketamine and propofol on neuronal damage markers and long-term neurological outcomes, this study aims to identify a potentially effective intervention to improve the prognosis of OHCA patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| S-ketamin | Experimental | Drug: esketamine hydrochlorideIntravenous or intraosseous bolus administration at a minimum of 0.5 mg/kg of esketamine |
| Propofol | Active comparator | Drug: propofolPrehospital intravenous or intraosseous bolus administration of a minimum dose of 0.25 mg/kg propofol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults (age ≥18 years) AND
- resuscitated OHCA of presumed cardiac cause with a shockable first recorded heart rhythm AND
- mean arterial pressure (MAP) >40 mmHg AND
- a decision to perform prehospital intubation.
Key exclusion criteria (5 listed)
- Advanced life support termination-of-resuscitation (TOR) criteria met
- Systolic blood pressure >190 mmHg
- Known allergy to ketamine or propofol
- Chronic diseases making 180-day survival unlikely
- Body temperature <30° C.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| esketamine hydrochloridePrehospital intravenous or intraosseous bolus administration at a minimum of 0.5 mg/kg of esketamine | Drug | S-ketamin |
| propofolPrehospital intravenous or intraosseous bolus administration at a minimum dose of 0.25 mg/kg propofol | Drug | Propofol |
Primary outcome
Neuron-specific enolase (NSE) measured 48 hours after OHCA
Time frame: 48 hours after OHCA
To determine the neuroprotective efficacy of ketamine compared with propofol administered as part of sedation for intubation after initial resuscitation from OHCA
7 secondary outcomes
Death from any cause
Time frame: 180 days after cardiac arrest
Neurological outcome: modified Rankin Score (mRS)
Time frame: At 2 weeks (at discharge)
Neurological outcome: Cerebral Performance Categories (CPC)
Time frame: At 2 weeks (at discharge)
Neurological outcome: modified Rankin Score (mRS)
Time frame: At 180 days after OHCA.
Neurological outcome: modified Rankin Score (mRS)
Time frame: At 240 days after OHCA.
Neurological outcome: Cerebral Performance Categories (CPC)
Time frame: At 180 days after OHCA.
Neurological outcome: Cerebral Performance Categories (CPC)
Time frame: At 240 days after OHCA.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
- Individual participant dataSharing planned: No
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Active, not recruitingObservational study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing esketamine hydrochloride and propofol in people with Out-of-hospital Cardiac Arrest (OHCA), run by Christian Hassager at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Salma Charabi, MD (35450572, salma.charabi@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuron-specific enolase (NSE) measured 48 hours after OHCA (time frame: 48 hours after OHCA). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2024.