Cardiac arrest & resuscitation
Continuous deep sedation versus minimal sedation after cardiac arrest and resuscitation (SED‐CARE): A protocol for a randomized clinical trial
Study context
- Population
- Adults comatose after resuscitation from out-of-hospital cardiac arrest (OHCA) with sustained return of spontaneous circulation (ROSC), randomised within 4 hoursplanned enrolment
- Participants
- 3,500 participants
- Planned comparison
- Continuous deep sedation vs minimal sedation for 36 h after ROSC
- Primary endpoint
- All-cause mortality
- Follow-up
- 6 months after randomization
Methodological details2 × 2 × 2 factorial, international, multicentre, parallel-group, investigator-initiated, superiority, Neurological prognostication per ERC and ESICM guidelines by a physician blinded to allocation, Sample size: 3500 to detect an absolute risk reduction of 5.6% (alpha 0.05, 90% power), Secondary outcomes: poor functional outcome at 6 months, serious adverse events in the ICU, patient-reported overall health status at 6 months
- 2 × 2 × 2 factorial
- International
- Multicentre
- Parallel-group
- Investigator-initiated
- Superiority
- Neurological prognostication per ERC and ESICM guidelines by a physician blinded to allocation
- Sample size: 3500 to detect an absolute risk reduction of 5.6% (alpha 0.05, 90% power)
- Secondary outcomes: poor functional outcome at 6 months, serious adverse events in the ICU, patient-reported overall health status at 6 months
No results yet. This paper sets out the design of a trial; its results are to come.
Original publication
Continuous deep sedation versus minimal sedation after cardiac arrest and resuscitation (SED‐CARE): A protocol for a randomized clinical trial. Acta Anaesthesiol Scand. Published 3 April 2025. doi:10.
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