Sedation, Temperature and Pressure After Cardiac Arrest and Resuscitation

Not Applicable

Recruiting

• Conditions: Cardiac Arrest With Successful Resuscitation; Hypoxia, Brain

• 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.

Study Timeline

• Study First Submitted: 2022-09-29
• Study First Submitted QC: 2022-09-29
• Study First Posted: 2022-10-03
• Study Start: 2023-08-17
• Status Verified: 2025-06
• Last Update Submitted: 2025-07-13
• Last Update Posted: 2025-07-15
• Primary Completion: 2026-12
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

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 (56)

HUB Hôpital Erasme; 🇧🇪 Brussels, Belgium

Ghent University Hospital; 🇧🇪 Ghent, Belgium

Ziekenhuis Oost-Limburg Hospital; 🇧🇪 Lanaken, Belgium

North Estonia Medical Centre, Tallinn; 🇪🇪 Tallinn, Estonia

Meilahti Hospital; 🇫🇮 Helsinki, Finland

Jyväskylä Hospital; 🇫🇮 Jyväskylä, Finland

Charite University Hospital; 🇩🇪 Berlin, Germany

Tubingen University Hospital; 🇩🇪 Tübingen, Germany

St Vincents University Hospital; 🇮🇪 Dublin, Ireland

San Martino Hospital Genova; 🇮🇹 Genova, Italy

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