Out-of-hospital Cardiac Arrest (OHCA)
Conditions
Brief 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. 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.
Interventions
Prehospital intravenous or intraosseous bolus administration at a minimum of 0.5 mg/kg of esketamine
DRUGpropofol
Prehospital intravenous or intraosseous bolus administration at a minimum dose of 0.25 mg/kg propofol
Sponsors
Christian Hassager
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neuron-specific enolase (NSE) measured 48 hours after OHCA | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Death from any cause | 180 days after cardiac arrest | Death from any cause 180 days after cardiac arrest |
| Neurological outcome: modified Rankin Score (mRS) | At 2 weeks (at discharge) | Neurological outcome by and modified Rankin Score (mRS). Meassured from 0 to 6, where 0 is no symptoms. |
| Neurological outcome: Cerebral Performance Categories (CPC) | At 2 weeks (at discharge) | Neurological outcome by Cerebral Performance Categories (CPC) meassured fra 1-5 (a score of 1 is normal/good cerebral function). |
Countries
Denmark
Contacts
Primary ContactSalma Charabi, MD
Outcome results
None listed