Sedation, Temperature and Pressure After Cardiac Arrest and Resuscitation (STEPCARE)

Region Skane

Status: Enrolling

Conditions: Cardiac Arrest With Successful Resuscitation; Hypoxia, Brain

Treatments: Other: High MAP; Device: Feedback-controlled temperature device; Other: Deep sedation; Other: Fever control without a device; Other: Low MAP; Other: Minimal sedation

Study type: Interventional

Funder types: Other

Identifiers

NCT05564754

step2022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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
5. Trauma or hemorrhage being the presumed cause of arrest

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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3,500 participants in 8 patient groups

Sedation, temperature device and high MAP

Active Comparator group

Description:

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.

Treatment:

Other: Deep sedation

Device: Feedback-controlled temperature device

Other: High MAP

Sedation, no temperature device and high MAP

Active Comparator group

Description:

Continuous deep sedation for 36 hours. Fever management without a feedback-controlled device. A mean arterial pressure target of \>85mmHg.

Treatment:

Other: Fever control without a device

Other: Deep sedation

Other: High MAP

Sedation, temperature device and low MAP

Active Comparator group

Description:

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.

Treatment:

Other: Low MAP

Other: Deep sedation

Device: Feedback-controlled temperature device

Sedation, no temperature device and low MAP

Active Comparator group

Description:

Continuous deep sedation for 36 hours. Fever management without a feedback-controlled device. A mean arterial pressure target of \>65mmHg.

Treatment:

Other: Low MAP

Other: Fever control without a device

Other: Deep sedation

Minimal sedation, temperature device and high MAP

Active Comparator group

Description:

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.

Treatment:

Other: Minimal sedation

Device: Feedback-controlled temperature device

Other: High MAP

Minimal sedation, no temperature device and high MAP

Active Comparator group

Description:

Minimal sedation (and early extubation if possible). Fever management without a feedback-controlled device. A mean arterial pressure target of \>65mmHg.

Treatment:

Other: Minimal sedation

Other: Fever control without a device

Other: High MAP

Minimal sedation, temperature device and low MAP

Active Comparator group

Description:

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.

Treatment:

Other: Minimal sedation

Other: Low MAP

Device: Feedback-controlled temperature device

Minimal sedation, no temperature device and low MAP

Active Comparator group

Description:

Minimal sedation (and early extubation if possible). Fever management without a feedback-controlled device. A mean arterial pressure target of \>65mmHg.

Treatment:

Other: Minimal sedation

Other: Low MAP

Other: Fever control without a device