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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hypoxia, Brain; Cardiac Arrest With Successful Resuscitation
• Intervention / Treatment: Device: Feedback-controlled temperature device; Other: High MAP; Other: Deep sedation; Other: Fever control without a device; Other: Low MAP; Other: Minimal sedation

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 Type: Interventional
• Enrollment (Estimated): 3500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Kingswood, New South Wales, Australia
      • Nepean Hospital
    • Liverpool, New South Wales, Australia
      • Liverpool Hospital
    • Sydney, New South Wales, Australia
      • St George Hospital
    • Sydney, New South Wales, Australia
      • Royal North Shore Hospital
    • Sydney, New South Wales, Australia
      • The Sutherland Hospital
  • Queensland
    • Brisbane, Queensland, Australia
      • Princess Alexandra Hospital
    • Brisbane, Queensland, Australia
      • The Prince Charles Hospital
  • Victoria
    • Melbourne, Victoria, Australia
      • Austin Hospital
• Belgium
  • Brussels, Belgium, 1077
    • HUB Hôpital Erasme
  • Ghent, Belgium, 9000
    • Ghent University Hospital
  • Lanaken, Belgium, 3620
    • Ziekenhuis Oost-Limburg Hospital
• Estonia
  • Tallinn, Estonia, 13409
    • North Estonia Medical Centre, Tallinn
• Finland
  • Espoo, Finland
    • Jorvi Hospital
  • Helsinki, Finland, 00290
    • Meilahti Hospital
  • Helsinki, Finland
    • Helsinki Helsingforgs University Central Hospital
  • Jyväskylä, Finland
    • Jyväskylä Hospital
  • Kuopio, Finland
    • Kuopio University Hospital
  • Oulu, Finland
    • Oulu University Hospital
  • Tampere, Finland
    • Tampere University Hospital
• Germany
  • Berlin, Germany
    • Charite University Hospital
  • Lübeck, Germany
    • Lübeck University Hospital
  • Tübingen, Germany
    • Tubingen University Hospital
• Ireland
  • Dublin, Ireland
    • St Vincents University Hospital
• Italy
  • Genova, Italy
    • San Martino Hospital Genova
• Luxembourg
  • Luxembourg, Luxembourg
    • Centre Hospitalier de Luxembourg
• New Zealand
  • Auckland, New Zealand
    • DCCM ICU
  • Auckland, New Zealand
    • Middlemore ICU
  • Auckland, New Zealand
    • North Shore ICU NZ
  • Christchurch, New Zealand
    • Christchurch Hospital
  • Northland, New Zealand
    • Whangarei ICU
  • Wellington, New Zealand
    • Wellington Hospital
• Norway
  • Arendal, Norway
    • Soerlandet Hospital Arendal
  • Kalnes, Norway
    • Kalnes Hospital
  • Oslo, Norway
    • Oslo University Hospital
  • Stavanger, Norway
    • Stavanger University Hospital
• Saudi Arabia
  • Riyadh, Saudi Arabia
    • King Abdulaziz Medical City
• Singapore
  • Singapore, Singapore
    • Tan Tock Seng Hospital
• Sweden
  • Gothenburg, Sweden
    • Sahlgrenska University Hospital
  • Karlstad, Sweden
    • Karlstad hospital
  • Skövde, Sweden
    • Skaraborg Hospital Skovde
  • Stockholm, Sweden
    • Karolinska University Hospital
  • Umeå, Sweden
    • University Hospital of Umeå
  • Halland County
    • Halmstad, Halland County, Sweden
      • Hallands hospital
  • Skåne County
    • Helsingborg, Skåne County, Sweden
      • Helsingborg Hospital
    • Lund, Skåne County, Sweden
      • Skåne University Hospital
    • Malmö, Skåne County, Sweden
      • Skane University Hospital Malmo
• Switzerland
  • Bern, Switzerland
    • Bern University Hospital
  • Sankt Gallen, Switzerland
    • St Gallen Hospital
  • Zurich, Switzerland
    • University Hospital Zurich
• United Kingdom
  • Basildon, United Kingdom
    • Essex Cardiothoracic Centre
  • Bristol, United Kingdom
    • Bristol Royal Infirmary
  • Cardiff, United Kingdom
    • Cardiff University Hospital
  • Leeds, United Kingdom
    • Leeds General Infirmary
  • London, United Kingdom
    • Kings College Hospital
  • London, United Kingdom
    • St Bartholomew'S Hospital
  • London, United Kingdom
    • St Georges University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Triple

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Sedation, temperature device and 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.	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
Active Comparator: Sedation, no temperature device and high MAP; Continuous deep sedation for 36 hours. Fever management without a feedback-controlled device. A mean arterial pressure target of >85mmHg.	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
Active Comparator: Sedation, temperature device and 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.	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: Deep sedation; Deep sedation for at least 36h; Other: Low MAP; A MAP target of >65mmHg will be used. Vasopressors will be titrated to this target during 36h.
Active Comparator: Sedation, no temperature device and low MAP; Continuous deep sedation for 36 hours. Fever management without a feedback-controlled device. A mean arterial pressure target of >65mmHg.	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.
Active Comparator: Minimal sedation, temperature device and 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.	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: Minimal sedation; A strategy of minimal sedation in the ICU, used only as needed to facilitate transport, imaging and invasive procedures.
Active Comparator: Minimal sedation, no temperature device and high MAP; Minimal sedation (and early extubation if possible). Fever management without a feedback-controlled device. A mean arterial pressure target of >65mmHg.	Other: High MAP; A MAP target of >85mmHg will be used. Vasopressors will be titrated to this target during 36h.; Other: Fever control without a device; Management of fever in the ICU without a device; Other: Minimal sedation; A strategy of minimal sedation in the ICU, used only as needed to facilitate transport, imaging and invasive procedures.
Active Comparator: Minimal sedation, temperature device and 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.	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: 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.
Active Comparator: Minimal sedation, no temperature device and low MAP; Minimal sedation (and early extubation if possible). Fever management without a feedback-controlled device. A mean arterial pressure target of >65mmHg.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Landmark mortality at follow-up performed at 6 months	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional outcome	Proportion of patients who have a mRS score of 4-6	6 months
Health-related quality of life	EQ5D-5L VAS	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
ICU stay	Length of stay for ICU survivors	6 months
Days at home within the first 30 days	Days outside of hospital within the first 30 days	30 days

Collaborators and Investigators

• Sponsor: Region Skane
• Collaborators: The George Institute for Global Health, Australia; Copenhagen Trial Unit, Center for Clinical Intervention Research; University Hospital of Wales; Lund University, Lund, Sweden; HUS Helsinki University Hospitals, Helsinki, Finland; Medical Research Institute of New Zealand Rangahautia Te Ora, Wellington, New Zealand
• Investigators: Study Chair: Niklas Nielsen, PhD, Lund University

Publications and helpful links

Helpful Links

• Trial webpage

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2023
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: September 29, 2022
• First Submitted That Met QC Criteria: September 29, 2022
• First Posted (Actual): October 3, 2022

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Signs and Symptoms, Respiratory; Hypoxia; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hypoxia, Brain; Anesthesia and Analgesia; Deep Sedation
• Other Study ID Numbers: step2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Upon reasonable request following publication

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No