Sedation, Temperature and Pressure After Cardiac Arrest and Resuscitation

Last updated: June 1, 2026
Sponsor: Region Skane
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

N/A

Treatment

Minimal sedation

Fever control without a device

Feedback-controlled temperature device

Clinical Study ID

NCT05564754
step2022
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Out-of-hospital cardiac arrest

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

  3. Unconsciousness defined as not being able to obey verbal commands (FOUR-score motorresponse of <4) or being intubated and sedated because of agitation after sustainedROSC.

  4. Eligible for intensive care without restrictions or limitations

  5. Inclusion within 4 hours of ROSC

Exclusion

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

Total Participants: 3500
Treatment Group(s): 6
Primary Treatment: Minimal sedation
Phase:
Study Start date:
August 17, 2023
Estimated Completion Date:
March 31, 2027

Study 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.

Connect with a study center

  • Nepean Hospital

    Kingswood, New South Wales
    Australia

    Site Not Available

  • Liverpool Hospital

    Liverpool, New South Wales
    Australia

    Site Not Available

  • Concord Repatriation Hospital

    Sydney, New South Wales
    Australia

    Site Not Available

  • Royal North Shore Hospital

    Sydney, New South Wales
    Australia

    Site Not Available

  • St George Hospital

    Sydney, New South Wales
    Australia

    Site Not Available

  • The Sutherland Hospital

    Sydney, New South Wales
    Australia

    Site Not Available

  • Princess Alexandra Hospital

    Brisbane, Queensland
    Australia

    Site Not Available

  • The Prince Charles Hospital

    Brisbane, Queensland
    Australia

    Site Not Available

  • Austin Hospital

    Melbourne, Victoria
    Australia

    Site Not Available

  • The Victorian Heart Hospital

    Melbourne, Victoria
    Australia

    Site Not Available

  • HUB Hôpital Erasme

    Brussels, 1077
    Belgium

    Site Not Available

  • Ghent University Hospital

    Ghent, 9000
    Belgium

    Site Not Available

  • Ziekenhuis Oost-Limburg Hospital

    Lanaken, 3620
    Belgium

    Site Not Available

  • North Estonia Medical Centre, Tallinn

    Tallinn, 13409
    Estonia

    Site Not Available

  • Jorvi Hospital

    Espoo,
    Finland

    Site Not Available

  • Helsinki Helsingforgs University Central Hospital

    Helsinki,
    Finland

    Site Not Available

  • HelsinkiHelsingforgs University Central Hospital

    Helsinki,
    Finland

    Site Not Available

  • Meilahti Hospital

    Helsinki, 00290
    Finland

    Site Not Available

  • Jyväskylä Hospital

    Jyväskylä,
    Finland

    Site Not Available

  • Kuopio University Hospital

    Kuopio,
    Finland

    Site Not Available

  • Oulu University Hospital

    Oulu,
    Finland

    Site Not Available

  • Tampere University Hospital

    Tampere,
    Finland

    Site Not Available

  • Charite University Hospital

    Berlin,
    Germany

    Site Not Available

  • Lübeck University Hospital

    Lübeck,
    Germany

    Site Not Available

  • Tubingen University Hospital

    Tübingen,
    Germany

    Site Not Available

  • St Vincents University Hospital

    Dublin,
    Ireland

    Site Not Available

  • San Martino Hospital Genova

    Genova,
    Italy

    Site Not Available

  • Centre Hospitalier de Luxembourg

    Luxembourg,
    Luxembourg

    Site Not Available

  • DCCM ICU

    Auckland,
    New Zealand

    Site Not Available

  • Middlemore ICU

    Auckland,
    New Zealand

    Site Not Available

  • North Shore ICU NZ

    Auckland,
    New Zealand

    Site Not Available

  • Christchurch Hospital

    Christchurch,
    New Zealand

    Site Not Available

  • Whangarei ICU

    Northland,
    New Zealand

    Site Not Available

  • Wellington Hospital

    Wellington,
    New Zealand

    Site Not Available

  • Soerlandet Hospital Arendal

    Arendal,
    Norway

    Site Not Available

  • Kalnes Hospital

    Kalnes,
    Norway

    Site Not Available

  • Oslo University Hospital

    Oslo,
    Norway

    Site Not Available

  • Stavanger University Hospital

    Stavanger,
    Norway

    Site Not Available

  • King Abdulaziz Medical City

    Riyadh,
    Saudi Arabia

    Site Not Available

  • Tan Tock Seng Hospital

    Singapore,
    Singapore

    Site Not Available

  • Hallands hospital

    Halmstad, Halland County
    Sweden

    Site Not Available

  • Helsingborg Hospital

    Helsingborg, Skåne County
    Sweden

    Site Not Available

  • Skåne University Hospital

    Lund, Skåne County
    Sweden

    Site Not Available

  • Skåne University Hospital Malmö

    Malmö, Skåne County
    Sweden

    Site Not Available

  • Sahlgrenska University Hospital

    Gothenburg,
    Sweden

    Site Not Available

  • Karlstad hospital

    Karlstad,
    Sweden

    Site Not Available

  • Skaraborg Hospital Skovde

    Skövde,
    Sweden

    Site Not Available

  • Karolinska University Hospital

    Stockholm,
    Sweden

    Site Not Available

  • University Hospital of Umeå

    Umeå,
    Sweden

    Site Not Available

  • Bern University Hospital

    Bern,
    Switzerland

    Site Not Available

  • St Gallen Hospital

    Sankt Gallen,
    Switzerland

    Site Not Available

  • University Hospital Zürich

    Zurich,
    Switzerland

    Site Not Available

  • Essex Cardiothoracic Centre

    Basildon,
    United Kingdom

    Site Not Available

  • Bristol Royal Infirmary

    Bristol,
    United Kingdom

    Site Not Available

  • Cardiff University Hospital

    Cardiff,
    United Kingdom

    Site Not Available

  • Leeds General Infirmary

    Leeds,
    United Kingdom

    Site Not Available

  • Kings College Hospital

    London,
    United Kingdom

    Site Not Available

  • St Bartholomew's Hospital

    London,
    United Kingdom

    Site Not Available

  • St Georges University Hospital

    London,
    United Kingdom

    Site Not Available

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