Overview
The STEPCARE-trial is a 2x2x2 randomised trial studying patients who have been resuscitated from cardiac arrest and who are comatose. It will include three different interventions focusing on sedation targets, temperature targets and mean arterial pressure targets.
Description
3500 patients who are comatose after cardiac arrest will be included in a trial studying three separate targets. All patients will be randomised to a control or an intervention arm for sedation, temperature and blood pressure targets. These are.
- Continuous deep sedation for 36 hours or minimal sedation (SEDCARE)
- Fever management with or without a feedback-controlled device (TEMPCARE)
- A mean arterial pressure target of >85mmHg or >65mmHg. (MAPCARE)
Participants will be followed up at 30 days and 6 months. The primary outcome will be survival at 6 months.
Eligibility
Inclusion Criteria:
- Out-of-hospital cardiac arrest
- Sustained ROSC - defined as 20 minutes with signs of circulation without the need for chest compressions
- Unconsciousness defined as not being able to obey verbal commands (FOUR-score motor response of <4) or being intubated and sedated because of agitation after sustained ROSC.
- Eligible for intensive care without restrictions or limitations
- Inclusion within 4 hours of ROSC
Exclusion Criteria:
- On ECMO prior to randomization
- Pregnancy
- Suspected or confirmed intracranial hemorrhage
- Previously randomized in the STEPCARE trial.