The STEPCARE-trial is designed with three major arms of interventions; targeted temperature management (TTM), mean arterial pressure (MAP) and sedation.
The STEPCARE (Sedation, Temperature and Pressure after Cardiac Arrest and Resuscitation) trial is a continuation of the collaboration that resulted in the previous Targeted Temperature Management after out-of-hospital cardiac arrest, Targeted Hypothermia versus Targeted Normothermia after Out-of-hospital Cardiac Arrest trials (hereafter: TTM1 and TTM2), and the COMACARE (Carbon dioxide, Oxygen and Mean arterial pressure After Cardiac Arrest and Resuscitation) trials. With its planned size STEPCARE will be the largest trial on intensive care unit (ICU) management after cardiac arrest.
Basic management for patients who have suffered a cardiac arrest and are admitted to an ICU includes setting goals for physiological parameters such as temperature, sedation, and blood pressure. However, optimal targets are unknown.
In an international collaboration STEPCARE will aim to improve the evidence for these aspects of care, and ultimately improve outcomes for patients who suffer a cardiac arrest.
The STEPCARE trial is an international, multicenter, parallel group, non-commercial, randomized, factorial, superiority trial in which sedation, temperature and blood pressure strategies will be studied.
Patients eligible for inclusion will be unconscious adult patients resuscitated from out-of-hospital cardiac arrest with stable return of spontaneous circulation. Randomization will be performed by a healthcare professional in the emergency department, in the angiography suite or in the ICU via web-based application using permuted blocks with varying sizes, stratified by site. Due to the nature of the interventions, clinicians responsible for the treatment of trial patients cannot be blinded to the interventions. However, outcome assessors, prognosticators, statisticians, management group, steering group and authors will be blinded to group allocation.
All patients will be randomized to three allocation groups, and each strategy will be studied separately regarding safety and reporting of results.
The three comparisons are:
Continuous sedation for 36 hours or minimal sedation (SED-CARE)
Fever management with or without a feedback-controlled device (TEMP-CARE)
A mean arterial pressure target of >85 mmHg or >65 mmHg. (MAP-CARE)
Participants who remain unconscious will be assessed according to a conservative protocol based on the European Resuscitation Council (ERC) and European Society of Intensive Care Medicine (ESICM) recommendations for neurological prognostication after cardiac arrest. Follow-up will be performed at 30 days and 6 months after cardiac arrest. The main results of the trial will be published following the 6-month follow-up in three separate articles. The trial protocol will describe all three interventions but separate protocol papers, one per intervention, will be published.