Sedation, Temperature and Pressure After Cardiac Arrest and Resuscitation
- Conditions
- Cardiac Arrest With Successful ResuscitationHypoxia, Brain
- Interventions
- Other: High MAPDevice: Feedback-controlled temperature deviceOther: Fever control without a deviceOther: Deep sedationOther: Low MAPOther: Minimal sedation
- Registration Number
- NCT05564754
- Lead Sponsor
- Region Skane
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 3500
- Out-of-hospital cardiac arrest
- Sustained ROSC - defined as 20 minutes with signs of circulation without the need for chest compressions
- Unconsciousness defined as not being able to obey verbal commands (FOUR-score motor response of <4) or being intubated and sedated because of agitation after sustained ROSC.
- Eligible for intensive care without restrictions or limitations
- Inclusion within 4 hours of ROSC
- On ECMO prior to randomization
- Pregnancy
- Suspected or confirmed intracranial hemorrhage
- Previously randomized in the STEPCARE trial.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Sedation, no temperature device and low MAP Fever control without a device Continuous deep sedation for 36 hours. Fever management without a feedback-controlled device. A mean arterial pressure target of \>65mmHg. Minimal sedation, no temperature device and high MAP High MAP Minimal sedation (and early extubation if possible). Fever management without a feedback-controlled device. A mean arterial pressure target of \>65mmHg. Minimal sedation, no temperature device and high MAP Minimal sedation Minimal sedation (and early extubation if possible). Fever management without a feedback-controlled device. A mean arterial pressure target of \>65mmHg. Sedation, temperature device and high MAP Feedback-controlled temperature 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 \>85mmHg. Sedation, no temperature device and high MAP Deep sedation Continuous deep sedation for 36 hours. Fever management without a feedback-controlled device. A mean arterial pressure target of \>85mmHg. Sedation, no temperature device and high MAP Fever control without a device Continuous deep sedation for 36 hours. Fever management without a feedback-controlled device. A mean arterial pressure target of \>85mmHg. Sedation, temperature device and low MAP Deep sedation 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. Minimal sedation, no temperature device and low MAP Low MAP Minimal sedation (and early extubation if possible). Fever management without a feedback-controlled device. A mean arterial pressure target of \>65mmHg. Sedation, temperature device and high MAP High MAP 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. Sedation, no temperature device and high MAP High MAP Continuous deep sedation for 36 hours. Fever management without a feedback-controlled device. A mean arterial pressure target of \>85mmHg. Sedation, temperature device and low MAP Feedback-controlled temperature 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. Sedation, temperature device and low MAP Low MAP 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. Minimal sedation, temperature device and low MAP Feedback-controlled temperature device 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. Minimal sedation, no temperature device and low MAP Fever control without a device Minimal sedation (and early extubation if possible). Fever management without a feedback-controlled device. A mean arterial pressure target of \>65mmHg. Sedation, temperature device and high MAP Deep sedation 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. Sedation, no temperature device and low MAP Deep sedation Continuous deep sedation for 36 hours. Fever management without a feedback-controlled device. A mean arterial pressure target of \>65mmHg. Sedation, no temperature device and low MAP Low MAP Continuous deep sedation for 36 hours. Fever management without a feedback-controlled device. A mean arterial pressure target of \>65mmHg. Minimal sedation, temperature device and high MAP High 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. Minimal sedation, no temperature device and high MAP Fever control without a device Minimal sedation (and early extubation if possible). Fever management without a feedback-controlled device. A mean arterial pressure target of \>65mmHg. Minimal sedation, temperature device and low MAP 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. Minimal sedation, temperature device and high MAP Feedback-controlled temperature device 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. Minimal sedation, temperature device and high MAP 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 \>85mmHg. Minimal sedation, temperature device and low MAP 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 \>65mmHg. Minimal sedation, no temperature device and low MAP Minimal sedation Minimal sedation (and early extubation if possible). Fever management without a feedback-controlled device. A mean arterial pressure target of \>65mmHg.
- Primary Outcome Measures
Name Time Method Mortality 6 months Landmark mortality at follow-up performed at 6 months
- Secondary Outcome Measures
Name Time Method Health-related quality of life 6 months EQ5D-5L VAS
Functional outcome 6 months Proportion of patients who have a mRS score of 4-6
Trial Locations
- Locations (30)
Wellington Hospital
🇳🇿Wellington, New Zealand
Austin Hospital
🇦🇺Melbourne, Victoria, Australia
St Gallen Hospital
🇨🇭Saint Gallen, Switzerland
Liverpool Hospital
🇦🇺Liverpool, New South Wales, Australia
Concord Repatriation Hospital
🇦🇺Sydney, New South Wales, Australia
Royal North Shore Hospital
🇦🇺Sydney, New South Wales, Australia
St George Hospital
🇦🇺Sydney, New South Wales, Australia
The Sutherland Hospital
🇦🇺Sydney, New South Wales, Australia
Oulu University Hospital
🇫🇮Oulu, Finland
John Hunter Hospital
🇦🇺Newcastle, New South Wales, Australia
Nepean Hospital
🇦🇺Kingswood, New South Wales, Australia
Westmead Hospital
🇦🇺Westmead, New South Wales, Australia
Princess Alexandra Hospital
🇦🇺Brisbane, Queensland, Australia
The Prince Charles Hospital
🇦🇺Brisbane, Queensland, Australia
Northern Hospital
🇦🇺Epping, Victoria, Australia
Jorvi Hospital
🇫🇮Espoo, Finland
Helsinki Helsingforgs University Central Hospital
🇫🇮Helsinki, Finland
Kuopio University Hospital
🇫🇮Kuopio, Finland
Tampere University Hospital
🇫🇮Tampere, Finland
Lübeck University Hospital
🇩🇪Lübeck, Germany
Christchurch Hospital
🇳🇿Christchurch, New Zealand
Centre Hospitalier de Luxembourg
🇱🇺Luxembourg, Luxembourg
Hallands hospital
🇸🇪Halmstad, Halland, Sweden
Helsingborg Hospital
🇸🇪Helsingborg, Skåne, Sweden
Skåne University Hospital
🇸🇪Lund, Skåne, Sweden
Skåne University Hospital Malmö
🇸🇪Malmö, Skåne, Sweden
Sahlgrenska University Hospital
🇸🇪Gothenburg, Sweden
Karolinska University Hospital
🇸🇪Solna, Sweden
University Hospital Zürich
🇨🇭Zürich, Switzerland
The Victorian Heart Hospital
🇦🇺Melbourne, Victoria, Australia