An interventional study of Feedback-controlled temperature device and High MAP in Acute Kidney Failure, Renal Replacement Therapy for Acute Kidney Injury in ICU and Sedation in Intensive Care Unit Patients, sponsored by Helsinki University Central Hospital. Active, not recruiting at 52 sites in 14 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-02.
Sponsored by Helsinki University Central Hospital · Not applicable, Interventional, and Treatment
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.
The main STEPCARE trial randomizes patients to three different interventions: (1) continuous deep sedation for 36 hours or minimal sedation (with extubation if feasible), (2) fever control with or without a feedback-controlled device if the temperature rises above 37.7°C, and (3) a mean arterial pressure (MAP) target of ≥65 mmHg or ≥85 mmHg.
This sub-study evaluates the effects of these three interventions on major adverse kidney events (MAKE), defined as a composite of death within 30 days, initiation of renal replacement therapy during the stay in the primary hospital, or persistent renal dysfunction, defined as a final creatinine value ≥200% of baseline at the time of discharge from the primary hospital.
Creatinine kinetics during the stay in the primary hospital and within 72 hours post-resuscitation are evaluated as secondary outcomes.
All data are collected prospectively as part of the main trial protocol, and analyses will be conducted according to a predefined statistical analysis plan.
1,691 studies on the registry are indexed under Acute Kidney Injury; 395 are open to participants now.
This study's planned enrollment of 3,500 is above the median of 100 across 817 interventional studies indexed under Acute Kidney Injury.
Browse Acute Kidney Injury studies →Helsinki University Central Hospital is the lead sponsor of 311 studies on the registry; 61 are open to participants now.
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Exclusion Criteria:
Continuous deep sedation for 36 hours, fever management with a feedback-controlled device if temperature rises above 37.7°C and a mean arterial pressure target of ≥85mmHg
Device: Feedback-controlled temperature device · Other: High MAP · Other: Deep sedation
Continuous deep sedation for 36 hours, fever management without a feedback-controlled device and a mean arterial pressure target of ≥85mmHg
Other: High MAP · Other: Deep sedation · Other: Fever control without a device
Continuous deep sedation for 36 hours, fever management with a feedback-controlled device if temperature rises above 37.7°C and a mean arterial pressure target of ≥65mmHg
Device: Feedback-controlled temperature device · Other: Deep sedation · Other: Low MAP
Continuous deep sedation for 36 hours, fever management without a feedback-controlled device and a mean arterial pressure target of ≥65mmHg
Other: Deep sedation · Other: Fever control without a device · Other: Low MAP
Minimal sedation (and early extubation if possible), fever management with a feedback-controlled device if temperature rises above 37.7°C and a mean arterial pressure target of ≥85mmHg
Device: Feedback-controlled temperature device · Other: High MAP · Other: Minimal sedation
Minimal sedation (and early extubation if possible), fever management without a feedback-controlled device and a mean arterial pressure target of ≥65mmHg
Other: High MAP · Other: Fever control without a device · Other: Minimal sedation
Minimal sedation (and early extubation if possible), fever management with a feedback-controlled device if temperature rises above 37.7°C and a mean arterial pressure target of ≥65mmHg
Device: Feedback-controlled temperature device · Other: Low MAP · Other: Minimal sedation
Minimal sedation (and early extubation if possible), fever management without a feedback-controlled device and a mean arterial pressure target of ≥65mmHg
Other: Fever control without a device · Other: Low MAP · Other: Minimal sedation
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
Major adverse kidney event (MAKE)
A composite endpoint of MAKE: death from any cause by day 30, initiation of RRT during the stay in the primary hospital or persistent renal dysfunction defined as final creatinine value ≥200 % of the baseline (the highest outpatient creatinine in the previous six months, or if unavailable, the creatinine on admission) at the time of discharge from the primary hospital
Time frame: 30 days
Difference between baseline and the highest in-hospital creatinine
Difference between baseline (the highest outpatient creatinine in the previous six months, or if unavailable, the creatinine on admission) and the highest in-hospital creatinine
Time frame: During the stay in the index hospital following cardiac arrest, until discharge or transfer to another hospital, and within 30 days
Difference between baseline and the last measured in-hospital creatinine
Difference between baseline (the highest outpatient creatinine in the previous six months, or if unavailable, the creatinine on admission) and the last measured in-hospital creatinine (in the primary hospital)
Time frame: At the time of discharge or transfer to another hospital from the index hospital following cardiac arrest, and within 30 days
Difference between baseline and 72-hour creatinine
Difference between baseline (the highest outpatient creatinine in the previous six months, or if unavailable, the creatinine on admission) and 72-hour creatinine
Time frame: 72 hours
Difference between baseline and the highest creatinine within 72 hours
Difference between baseline (the highest outpatient creatinine in the previous six months, or if unavailable, the creatinine on admission) and the highest creatinine within 72 hours
Time frame: 72 hours
Started Aug 2023 (actual). Primary completion is estimated for Dec 2026, 40 months after the start.
Of 249 non-industry interventional studies with no phase under Acute Kidney Injury, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 44. This study's planned 40 months is above that.
Counting every sponsor, half of 267 studies reached it within 26 months; a quarter within 12 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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