Overview
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After successful resuscitation, patients who survive a cardiac arrest often remain severely ill and require intensive care. Controlling depth of sedation, body temperature and mean arterial pressure are potential treatments that may prevent brain damage. The STEPCARE trial aims to study how to best apply these interventions.
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The STEPCARE trial is an international, investigator-initiated, randomized trial on three different aspects of standard care after out-of-hospital cardiac arrest. In a 2x2x2 factorial design we will compare the effect of continuous sedation vs. minimal sedation, fever management with a device vs. without a device and a higher blood pressure target vs. a lower blood pressure target.
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The primary outcome of the trial will be survival at 180 days with secondary outcomes including neurological function and health-related quality of life.
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Starting in 2023 the trial will include 3500 participants in Europe, Australia, New Zealand and Asia.
Inclusion criteria
1. Out-of-hospital cardiac arrest of non-traumatic origin
2. A minimum of 20 minutes without chest compressions*
3. 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
4. Eligible for intensive care without restrictions or limitations
5. Inclusion within 4 hours of ROSC **
Exclusion criteria
1. On ECMO prior to randomization
2. Pregnancy
3. Suspected or confirmed intracranial hemorrhage
4. Previously randomized in the STEPCARE trial
Intervention
