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Effects of Sedation, TEmperature and Pressure After Cardiac Arrest and REsuscitation on Major Adverse Kidney Events (STEPCARE-MAKE)
RECRUITINGN/ASponsored by Helsinki University Central Hospital
Actively Recruiting
PhaseN/A
SponsorHelsinki University Central Hospital
Started2023-08-17
Est. completion2026-12
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT07579390
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
Age: 18 Years+Healthy volunteers accepted
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
Conditions13
Acute Kidney FailureBlood PressureCardiac Arrest (CA)FeverHeart DiseaseMean Arterial Pressure TargetsOut-Of-Hospital Cardiac ArrestRenal Replacement Therapy for Acute Kidney Injury in ICUResuscitated Sudden Cardiac DeathSedation in Intensive Care
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Actively Recruiting
PhaseN/A
SponsorHelsinki University Central Hospital
Started2023-08-17
Est. completion2026-12
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT07579390