Overview
The STEPCARE-MAKE study is a predefined prospective sub-study of the 2x2x2 factorial STEPCARE trial, which evaluates the effects of three interventions in comatose adult patients resuscitated from out-of-hospital cardiac arrest. In this sub-study, all 3500 participants enrolled in the main trial are assessed for major adverse kidney events (MAKE) and creatinine kinetics.
Description
The main STEPCARE trial randomizes patients to three different interventions (1) continuous deep sedation for 36 hours or minimal sedation (and extubation if possible), (2) fever control with or without a feeback-controlled device if temperature rises above 37,7°C, (3) MAP-target ≥ 65 mmHg or ≥ 85 mmHg.
This sub-study evaluates the effects of the three interventions on major adverse kidney events (MAKE), defined as a composite of death (within 30 days), initiation of renal replacement therapy during the stay in the primary hospital, or persistent renal dysfunction, defined as a final creatinine value ≥ 200% of the baseline at the time of discharge from the primary hospital. Creatinine kinetics during the stay in the primary hospital and within 72 hours post-resuscitation are evaluated as secondary outcomes.
All data are collected prospectively as part of the main trial protocol, and analyses will be conducted according to a predefined statistical analysis plan.
Eligibility
Inclusion Criteria:
- All patients included to the main STEPCARE-trial are also included to this substudy
- Out-of-hospital cardiac arrest
- Sustained return of spontaneous circulation, defined as 20 minutes with signs of circulation without the need for chest compressions
- Unconsciousness (FOUR-score motor response \<4, inability to obey verbal commands), or being intubated and sedated due to agitation
- Eligible for intensive care without restrictions or limitations
- Inclusion within 4 hours of the return of spontaneous circulation
Exclusion Criteria:
- Out-of-hospital cardiac arrest of presumed traumatic or hemorrhagic origin
- Confirmed or suspected intracranial hemorrhage
- Pregnancy
- Extracorporeal membrane oxygenation (ECMO) prior to randomization
- No additional exclusion criteria are applied beyond those of the main STEPCARE trial
