NCT07579390 Effects of Sedation, TEmperature and Pressure After Cardiac Arrest and REsuscitation on Major Adverse Kidney Events (STEPCARE-MAKE)
| NCT ID | NCT07579390 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Helsinki University Central Hospital |
| Condition | Acute Kidney Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 3,500 participants |
| Start Date | 2023-08-17 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 3,500 participants in total. It began in 2023-08-17 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07579390 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Kidney Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07579390 currently recruiting?
Yes, NCT07579390 is actively recruiting participants. Contact the research team at markus.skrifvars@hus.fi for enrollment information.
Where is the NCT07579390 trial being conducted?
This trial is being conducted at Brisbane, Australia, Brisbane, Australia, Kingswood, Australia, Liverpool, Australia and 11 additional locations.
Who is sponsoring the NCT07579390 clinical trial?
NCT07579390 is sponsored by Helsinki University Central Hospital. The trial plans to enroll 3,500 participants.
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