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How sedation, temperature control, and blood pressure targets after cardiac arrest affect major kidney problems

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

Not applicable Interventional Helsinki University Central Hospital · NCT07579390

This study tests whether deeper versus lighter sedation, using a feedback-controlled fever device or not, and higher versus lower blood pressure targets after out-of-hospital cardiac arrest change the risk of major kidney problems in adults who are unconscious after resuscitation.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment3500 (estimated)
Ages18 Years and up
SexAll
SponsorHelsinki University Central Hospital Academic / other
Locations52 sites (Brisbane and 51 other locations)
Trial IDNCT07579390 on ClinicalTrials.gov

What this trial studies

STEPCARE-MAKE is a predefined prospective substudy embedded in a 2x2x2 factorial trial that includes about 3,500 comatose adults resuscitated from out-of-hospital cardiac arrest. Participants in the main trial are randomized to sedation depth (continuous deep sedation for 36 hours versus minimal sedation), temperature management (fever control with or without a feedback-controlled device), and mean arterial pressure targets (≥65 mmHg versus ≥85 mmHg). This substudy measures major adverse kidney events (MAKE)—a composite of 30-day death, initiation of renal replacement therapy during the primary hospital stay, or persistent renal dysfunction defined as discharge creatinine ≥200% of baseline—and analyzes creatinine kinetics including the first 72 hours after resuscitation. All data are collected prospectively as part of the main trial and will be analyzed according to a predefined statistical analysis plan.

Who should consider this trial

Good fit: Ideal candidates are adults resuscitated from out-of-hospital cardiac arrest who remain unconscious or are intubated and sedated, are eligible for intensive care without limitations, and can be enrolled within four hours of return of spontaneous circulation.

Not a fit: Patients with presumed traumatic or hemorrhagic cardiac arrest, confirmed or suspected intracranial hemorrhage, pregnancy, or those on ECMO before randomization are excluded and therefore will not receive benefit from this substudy.

Why it matters

Potential benefit: If successful, the results could help reduce deaths, need for dialysis, or lasting kidney damage after cardiac arrest by identifying better sedation, temperature, and blood pressure strategies.

How similar studies have performed: Prior trials of temperature management and blood pressure targets after cardiac arrest have shown mixed effects on survival and neurological outcomes, and the specific impact on major kidney events is less well established, making this a relatively underexplored outcome.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Brisbane and 51 other locations

+2 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Acute Kidney FailureRenal Replacement Therapy for Acute Kidney Injury in ICUSedation in Intensive Care Unit PatientsSedation in the ICUSedation in Intensive CareBlood PressureMean Arterial Pressure TargetsTemperature
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.