Effects of Sedation, TEmperature and Pressure After Cardiac Arrest and REsuscitation on Major Adverse Kidney Events (STEPCARE-MAKE)
Effects of Sedation, TEmperature and Pressure After Cardiac Arrest and REsuscitation on Major Adverse Kidney Events (STEPCARE-MAKE): a Protocol for a Pre-planned Sub-study of a Randomized Clinical Trial
Helsinki University Central Hospital
3,500 participants
Aug 17, 2023
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria6
- 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 Criteria4
- Out-of-hospital cardiac arrest of presumed traumatic or hemorrhagic origin
- Confirmed or suspected intracranial hemorrhage
- Pregnancy
- Extracorporeal membrane oxygenation (ECMO) prior to randomization
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
If core body temperature exceeds 37.7°C a feedback-controlled device will be used and set at 37.5°C
A MAP target of \>85mmHg will be used. Vasopressors will be titrated to this target during 36h
Deep sedation for at least 36h
Management of fever in the ICU without a device
A MAP target of \>65mmHg will be used. Vasopressors will be titrated to this target during 36h
A strategy of minimal sedation in the ICU, sedation used only as needed to facilitate transport, imaging and invasive procedures
Locations(52)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07579390