Sedation, Temperature and Pressure After Cardiac Arrest and Resuscitation

Hypoxia, Brain Clinical Trial

— STEPCARE  

Official title:

Sedation, Temperature and Pressure After Cardiac Arrest and Resuscitation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05564754
• Other study ID #: step2022
• Status: Recruiting
• Phase: N/A
• Start date: August 17, 2023
• Est. completion date: June 2026

Study information

• Verified date: March 2024
• Source: Region Skane
• Contact: Josef Dankiewicz, PhD
• Phone: +464671000
• Email: josef.dankiewicz[@]med.lu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 3500
• Est. completion date: June 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Out-of-hospital cardiac arrest

2. Sustained ROSC - defined as 20 minutes with signs of circulation without the need for chest compressions

3. 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.

4. Eligible for intensive care without restrictions or limitations

5. Inclusion within 4 hours of ROSC

Exclusion Criteria:

1. On ECMO prior to randomization

2. Pregnancy

3. Suspected or confirmed intracranial hemorrhage

4. Previously randomized in the STEPCARE trial.

Related Conditions & MeSH terms

• Cardiac Arrest With Successful Resuscitation
• Heart Arrest
• Hypoxia
• Hypoxia, Brain

Intervention

Device:
• Feedback-controlled temperature device
If core body temperature exceeds 37.7°C a feedback controlled-device will be used and set at 37.5°C.

Other:
• High MAP
A MAP target of >85mmHg will be used. Vasopressors will be titrated to this target during 36h.
• Deep sedation
Deep sedation for at least 36h
• Fever control without a device
Management of fever in the ICU without a device
• Low MAP
A MAP target of >65mmHg will be used. Vasopressors will be titrated to this target during 36h.
• Minimal sedation
A strategy of minimal sedation in the ICU, used only as needed to facilitate transport, imaging and invasive procedures.

Locations

Country	Name	City	State
Australia	Princess Alexandra Hospital	Brisbane	Queensland
Australia	The Prince Charles Hospital	Brisbane	Queensland
Australia	Northern Hospital	Epping	Victoria
Australia	Nepean Hospital	Kingswood	New South Wales
Australia	Liverpool Hospital	Liverpool	New South Wales
Australia	Austin Hospital	Melbourne	Victoria
Australia	The Victorian Heart Hospital	Melbourne	Victoria
Australia	John Hunter Hospital	Newcastle	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	Westmead Hospital	Westmead	New South Wales
Finland	Jorvi Hospital	Espoo
Finland	Helsinki Helsingforgs University Central Hospital	Helsinki
Finland	Kuopio University Hospital	Kuopio
Finland	Oulu University Hospital	Oulu
Finland	Tampere University Hospital	Tampere
Germany	Lübeck University Hospital	Lübeck
Luxembourg	Centre Hospitalier de Luxembourg	Luxembourg
New Zealand	Christchurch Hospital	Christchurch
New Zealand	Wellington Hospital	Wellington
Sweden	Sahlgrenska University Hospital	Gothenburg
Sweden	Hallands hospital	Halmstad	Halland
Sweden	Helsingborg Hospital	Helsingborg	Skåne
Sweden	Skåne University Hospital	Lund	Skåne
Sweden	Skåne University Hospital Malmö	Malmö	Skåne
Sweden	Karolinska University Hospital	Solna
Switzerland	St Gallen Hospital	Saint Gallen
Switzerland	University Hospital Zürich	Zürich

Sponsors (6)

Lead Sponsor	Collaborator
Region Skane	Copenhagen Trial Unit, Center for Clinical Intervention Research, HUS Helsinki University Hospitals, Helsinki, Finland, Lund University, Lund, Sweden, Medical Research Institute of New Zealand Rangahautia Te Ora, Wellington, New Zealand, The George Institute for Global Health, Australia

Countries where clinical trial is conducted

Australia,  Finland,  Germany,  Luxembourg,  New Zealand,  Sweden,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	ICU stay	Length of stay for ICU survivors	6 months
Other	Days at home within the first 30 days	Days outside of hospital within the first 30 days	30 days
Primary	Mortality	Landmark mortality at follow-up performed at 6 months	6 months
Secondary	Functional outcome	Proportion of patients who have a mRS score of 4-6	6 months
Secondary	Health-related quality of life	EQ5D-5L VAS	6 months

External Links

•   Trial webpage