Sedation, Temperature and Pressure After Cardiac Arrest and Resuscitation

Last updated: July 13, 2025
Sponsor: Region Skane
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

High MAP

Minimal sedation

Fever control without a 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: High MAP
Phase:
Study Start date:
August 17, 2023
Estimated Completion Date:
December 31, 2026

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

    Active - Recruiting

  • Liverpool Hospital

    Liverpool, New South Wales
    Australia

    Active - Recruiting

  • John Hunter Hospital

    Newcastle, 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

    Active - Recruiting

  • St George Hospital

    Sydney, New South Wales
    Australia

    Active - Recruiting

  • The Sutherland Hospital

    Sydney, New South Wales
    Australia

    Active - Recruiting

  • Westmead Hospital

    Westmead, New South Wales
    Australia

    Site Not Available

  • Princess Alexandra Hospital

    Brisbane, Queensland
    Australia

    Active - Recruiting

  • The Prince Charles Hospital

    Brisbane, Queensland
    Australia

    Active - Recruiting

  • Northern Hospital

    Epping, Victoria
    Australia

    Site Not Available

  • Austin Hospital

    Melbourne, Victoria
    Australia

    Active - Recruiting

  • The Victorian Heart Hospital

    Melbourne, Victoria
    Australia

    Site Not Available

  • HUB Hôpital Erasme

    Brussels, 1077
    Belgium

    Active - Recruiting

  • Ghent University Hospital

    Ghent, 9000
    Belgium

    Active - Recruiting

  • Ziekenhuis Oost-Limburg Hospital

    Lanaken, 3620
    Belgium

    Active - Recruiting

  • North Estonia Medical Centre, Tallinn

    Tallinn, 13409
    Estonia

    Active - Recruiting

  • Jorvi Hospital

    Espoo,
    Finland

    Active - Recruiting

  • Helsinki Helsingforgs University Central Hospital

    Helsinki,
    Finland

    Active - Recruiting

  • HelsinkiHelsingforgs University Central Hospital

    Helsinki,
    Finland

    Site Not Available

  • Meilahti Hospital

    Helsinki, 00290
    Finland

    Active - Recruiting

  • Jyväskylä Hospital

    Jyväskylä,
    Finland

    Active - Recruiting

  • Kuopio University Hospital

    Kuopio,
    Finland

    Active - Recruiting

  • Oulu University Hospital

    Oulu,
    Finland

    Active - Recruiting

  • Tampere University Hospital

    Tampere,
    Finland

    Active - Recruiting

  • Charite University Hospital

    Berlin,
    Germany

    Active - Recruiting

  • Lübeck University Hospital

    Lübeck,
    Germany

    Active - Recruiting

  • Tubingen University Hospital

    Tübingen,
    Germany

    Active - Recruiting

  • St Vincents University Hospital

    Dublin,
    Ireland

    Site Not Available

  • San Martino Hospital Genova

    Genova,
    Italy

    Active - Recruiting

  • Centre Hospitalier de Luxembourg

    Luxembourg,
    Luxembourg

    Active - Recruiting

  • DCCM ICU

    Auckland,
    New Zealand

    Active - Recruiting

  • Middlemore ICU

    Auckland,
    New Zealand

    Active - Recruiting

  • North Shore ICU NZ

    Auckland,
    New Zealand

    Active - Recruiting

  • Christchurch Hospital

    Christchurch,
    New Zealand

    Active - Recruiting

  • Whangarei ICU

    Northland,
    New Zealand

    Site Not Available

  • Wellington Hospital

    Wellington,
    New Zealand

    Active - Recruiting

  • Soerlandet Hospital Arendal

    Arendal,
    Norway

    Active - Recruiting

  • Kalnes Hospital

    Kalnes,
    Norway

    Active - Recruiting

  • Oslo University Hospital

    Oslo,
    Norway

    Active - Recruiting

  • Stavanger University Hospital

    Stavanger,
    Norway

    Active - Recruiting

  • King Abdulaziz Medical City

    Riyadh,
    Saudi Arabia

    Active - Recruiting

  • Tan Tock Seng Hospital

    Singapore,
    Singapore

    Active - Recruiting

  • Hallands hospital

    Halmstad, Halland
    Sweden

    Active - Recruiting

  • Helsingborg Hospital

    Helsingborg, Skåne
    Sweden

    Active - Recruiting

  • Skåne University Hospital

    Lund, Skåne
    Sweden

    Active - Recruiting

  • Skåne University Hospital Malmö

    Malmö, Skåne
    Sweden

    Active - Recruiting

  • Sahlgrenska University Hospital

    Gothenburg,
    Sweden

    Active - Recruiting

  • Karlstad hospital

    Karlstad,
    Sweden

    Active - Recruiting

  • Skaraborg Hospital Skovde

    Skövde,
    Sweden

    Active - Recruiting

  • Karolinska University Hospital

    Solna,
    Sweden

    Site Not Available

  • Karolinska University Hospital

    Stockholm,
    Sweden

    Active - Recruiting

  • University Hospital of Umeå

    Umeå,
    Sweden

    Active - Recruiting

  • Bern University Hospital

    Bern,
    Switzerland

    Active - Recruiting

  • St Gallen Hospital

    Saint Gallen,
    Switzerland

    Active - Recruiting

  • University Hospital Zürich

    Zürich,
    Switzerland

    Active - Recruiting

  • Essex Cardiothoracic Centre

    Basildon,
    United Kingdom

    Active - Recruiting

  • Bristol Royal Infirmary

    Bristol,
    United Kingdom

    Active - Recruiting

  • Cardiff University Hospital

    Cardiff,
    United Kingdom

    Active - Recruiting

  • Leeds General Infirmary

    Leeds,
    United Kingdom

    Active - Recruiting

  • Kings College Hospital

    London,
    United Kingdom

    Active - Recruiting

  • St Bartholomew's Hospital

    London,
    United Kingdom

    Active - Recruiting

  • St Georges University Hospital

    London,
    United Kingdom

    Active - Recruiting

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