RecruitingNot ApplicableNCT05564754

Sedation, Temperature and Pressure After Cardiac Arrest and Resuscitation


Sponsor

Region Skane

Enrollment

3,500 participants

Start Date

Aug 17, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria5

  • Out-of-hospital cardiac arrest
  • Sustained ROSC - defined as 20 minutes with signs of circulation without the need for chest compressions
  • 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.
  • Eligible for intensive care without restrictions or limitations
  • Inclusion within 4 hours of ROSC

Exclusion Criteria5

  • On ECMO prior to randomization
  • Pregnancy
  • Suspected or confirmed intracranial hemorrhage
  • Previously randomized in the STEPCARE trial
  • Trauma or hemorrhage being the presumed cause of arrest

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Interventions

DEVICEFeedback-controlled temperature device

If core body temperature exceeds 37.7°C a feedback controlled-device will be used and set at 37.5°C.

OTHERHigh MAP

A MAP target of \>85mmHg will be used. Vasopressors will be titrated to this target during 36h.

OTHERDeep sedation

Deep sedation for at least 36h

OTHERFever control without a device

Management of fever in the ICU without a device

OTHERLow MAP

A MAP target of \>65mmHg will be used. Vasopressors will be titrated to this target during 36h.

OTHERMinimal sedation

A strategy of minimal sedation in the ICU, used only as needed to facilitate transport, imaging and invasive procedures.


Locations(56)

Nepean Hospital

Kingswood, New South Wales, Australia

Liverpool Hospital

Liverpool, New South Wales, Australia

Royal North Shore Hospital

Sydney, New South Wales, Australia

St George Hospital

Sydney, New South Wales, Australia

The Sutherland Hospital

Sydney, New South Wales, Australia

Princess Alexandra Hospital

Brisbane, Queensland, Australia

The Prince Charles Hospital

Brisbane, Queensland, Australia

Austin Hospital

Melbourne, Victoria, Australia

HUB Hôpital Erasme

Brussels, Belgium

Ghent University Hospital

Ghent, Belgium

Ziekenhuis Oost-Limburg Hospital

Lanaken, Belgium

North Estonia Medical Centre, Tallinn

Tallinn, Estonia

Jorvi Hospital

Espoo, Finland

Meilahti Hospital

Helsinki, Finland

Helsinki Helsingforgs University Central Hospital

Helsinki, Finland

Jyväskylä Hospital

Jyväskylä, Finland

Kuopio University Hospital

Kuopio, Finland

Oulu University Hospital

Oulu, Finland

Tampere University Hospital

Tampere, Finland

Charite University Hospital

Berlin, Germany

Lübeck University Hospital

Lübeck, Germany

Tubingen University Hospital

Tübingen, Germany

St Vincents University Hospital

Dublin, Ireland

San Martino Hospital Genova

Genova, Italy

Centre Hospitalier de Luxembourg

Luxembourg, Luxembourg

DCCM ICU

Auckland, New Zealand

Middlemore ICU

Auckland, New Zealand

North Shore ICU NZ

Auckland, New Zealand

Christchurch Hospital

Christchurch, New Zealand

Whangarei ICU

Northland, New Zealand

Wellington Hospital

Wellington, New Zealand

Soerlandet Hospital Arendal

Arendal, Norway

Kalnes Hospital

Kalnes, Norway

Oslo University Hospital

Oslo, Norway

Stavanger University Hospital

Stavanger, Norway

King Abdulaziz Medical City

Riyadh, Saudi Arabia

Tan Tock Seng Hospital

Singapore, Singapore

Hallands hospital

Halmstad, Halland County, Sweden

Helsingborg Hospital

Helsingborg, Skåne County, Sweden

Skåne University Hospital

Lund, Skåne County, Sweden

Skåne University Hospital Malmö

Malmo, Skåne County, Sweden

Sahlgrenska University Hospital

Gothenburg, Sweden

Karlstad hospital

Karlstad, Sweden

Skaraborg Hospital Skovde

Skövde, Sweden

Karolinska University Hospital

Stockholm, Sweden

University Hospital of Umeå

Umeå, Sweden

Bern University Hospital

Bern, Switzerland

St Gallen Hospital

Sankt Gallen, Switzerland

University Hospital Zürich

Zurich, Switzerland

Essex Cardiothoracic Centre

Basildon, United Kingdom

Bristol Royal Infirmary

Bristol, United Kingdom

Cardiff University Hospital

Cardiff, United Kingdom

Leeds General Infirmary

Leeds, United Kingdom

Kings College Hospital

London, United Kingdom

St Bartholomew's Hospital

London, United Kingdom

St Georges University Hospital

London, United Kingdom

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NCT05564754


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