Ketamine Sedation As Neuroprotective Agent Following Out-of-hospital Cardiac Arrest
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: esketamine hydrochloride, propofol.
- Who it may be relevant to
- Registry conditions: Out-of-hospital Cardiac Arrest (OHCA). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
KETamine Sedation As Neuroprotective Agent Following Out-of-hospital Cardiac Arrest (OHCA) - the KETOHCA Trial
Overview
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
- Drug esketamine hydrochloride
Prehospital intravenous or intraosseous bolus administration at a minimum of 0.5 mg/kg of esketamine - Drug propofol
Prehospital intravenous or intraosseous bolus administration at a minimum dose of 0.25 mg/kg propofol
Primary outcome measures
- Neuron-specific enolase (NSE) measured 48 hours after OHCA [Time frame: 48 hours after OHCA]
Secondary outcome measures (7)
- 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.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Denmark · 2 centers
- Department of Cardiology, Rigshospitalet — Copenhagen
- Odense University Hospital — Odense C
Identifiers
NCT: NCT06744361 · 2024-515987-29-00 · 2024-515987-29-00