NCT05564754

Sedation, Temperature and Pressure After Cardiac Arrest and Resuscitation

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 3,500 (estimated)
• Sponsor: Region Skane · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cardiac Arrest With Successful Resuscitation
• Hypoxia, Brain

Interventions

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

Timeline

• Start date: 2023-08-17
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2022-10-03
• Last updated: 2025-07-15

Locations

56 sites across 15 countries: Australia, Belgium, Estonia, Finland, Germany, Ireland, Italy, Luxembourg, New Zealand, Norway, Saudi Arabia, Singapore, Sweden, Switzerland, United Kingdom