An interventional study of Feedback-controlled temperature device and High MAP in Cardiac Arrest With Successful Resuscitation and Hypoxia, Brain, sponsored by Region Skane. Active, not recruiting at 56 sites in 15 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-02.
Sponsored by Region Skane · Not applicable, Interventional, and Treatment
The STEPCARE-trial is a 2x2x2 randomised trial studying patients who have been resuscitated from cardiac arrest and who are comatose. It will include three different interventions focusing on sedation targets, temperature targets and mean arterial pressure targets.
3500 patients who are comatose after cardiac arrest will be included in a trial studying three separate targets. All patients will be randomised to a control or an intervention arm for sedation, temperature and blood pressure targets. These are.
Participants will be followed up at 30 days and 6 months. The primary outcome will be survival at 6 months.
81 studies on the registry are indexed under Hypoxia, Brain; 19 are open to participants now.
This study's planned enrollment of 3,500 is above the median of 60 across 55 interventional studies indexed under Hypoxia, Brain.
Browse Hypoxia, Brain studies →Region Skane is the lead sponsor of 386 studies on the registry; 122 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Exclusion Criteria:
Continuous deep sedation for 36 hours Fever management with a feedback-controlled device if temperature above 37.7°C. 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. 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 above 37.7°C. 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. 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 above 37.7°C. 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. 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 above 37.7°C. 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. 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, used only as needed to facilitate transport, imaging and invasive procedures.
Mortality
Landmark mortality at follow-up performed at 6 months
Time frame: 6 months
Functional outcome
Proportion of patients who have a mRS score of 4-6
Time frame: 6 months
Health-related quality of life
EQ5D-5L VAS
Time frame: 6 months
ICU stay
Length of stay for ICU survivors
Time frame: 6 months
Days at home within the first 30 days
Days outside of hospital within the first 30 days
Time frame: 30 days
Plan to share: Undecided — Upon reasonable request following publication
Started Aug 2023 (actual). Primary completion is estimated for Jan 2027, 41 months after the start.
Of 33 non-industry interventional studies with no phase under Hypoxia, Brain, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 44. This study's planned 41 months is above that.
Counting every sponsor, half of 33 studies reached it within 20 months; a quarter within 7 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.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.