The STEPCARE-MAKE study is a predefined sub-study of the large Sedation, TEmperature and Pressure after Cardiac Arrest and REsuscitation (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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is studying how sedation levels, body temperature control, and blood pressure targets after cardiac arrest affect kidney outcomes — can you explain how these three factors might be interacting to affect my kidneys right now, and whether my current ICU care aligns with what this study is testing?
2The trial is measuring something called 'major adverse kidney events' or MAKE — what exactly does that mean for a patient like me, and how closely are my doctors monitoring my kidney function after resuscitation?
3Since this trial is active but no longer enrolling new patients, does that mean the treatment approaches being studied are already influencing how my care team is managing my sedation, temperature, and blood pressure, or is my treatment still based on older standard protocols?
4The study looks at mean arterial pressure targets specifically — can you walk me through what blood pressure goal my team is currently aiming for in my care, and whether there is still uncertainty in the medical community about what the right target is after cardiac arrest?
5Given that kidney failure and the need for dialysis are serious risks after cardiac arrest, what signs would indicate that my kidneys are struggling, and at what point would my care team consider kidney replacement therapy based on what is currently known?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.