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. 1. Continuous deep sedation for 36 hours or minimal sedation (SEDCARE) 2. Fever management with or without a feedback-controlled device (TEMPCARE) 3. A mean arterial pressure target of \>85mmHg or \>65mmHg. (MAPCARE) Participants will be followed up at 30 days and 6 months. The primary outcome will be survival at 6 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
3,500
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
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
Nepean Hospital
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