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Search / Trial NCT05564754

Sedation, Temperature and Pressure After Cardiac Arrest and Resuscitation

Launched by REGION SKANE · Sep 29, 2022

Trial Information

Current as of July 27, 2025

Recruiting

Keywords

ClinConnect Summary

The STEPCARE trial is studying how different treatments can help patients who have survived a cardiac arrest but are still unconscious. After a cardiac arrest, it's important to carefully manage the patient's sedation, body temperature, and blood pressure to support their recovery. This trial will look at three different approaches to find out which combination works best for these patients.

To be eligible for this study, participants must have had a cardiac arrest outside of the hospital and have been successfully resuscitated, meaning their heart is pumping again for at least 20 minutes without needing chest compressions. They also need to be unconscious and unable to follow commands or need sedation due to agitation. The trial is open to both men and women aged 65 and older, and participants will be enrolled within four hours after their heart has been restarted. If you or a family member meet these criteria, you may have the opportunity to take part in this important research that aims to improve care for patients after cardiac arrest.

Gender

ALL

Eligibility criteria

  • 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

About Region Skane

Region Skåne is a leading healthcare authority in Sweden, dedicated to advancing medical research and improving patient care through innovative clinical trials. Committed to fostering collaboration between researchers, healthcare professionals, and patients, Region Skåne aims to enhance the understanding of various health conditions and develop effective treatment strategies. With a focus on ethical standards and patient safety, the organization plays a pivotal role in shaping the future of healthcare in the region and beyond, ensuring that clinical trials are conducted with the highest level of scientific rigor and transparency.

Locations

Westmead, New South Wales, Australia

Liverpool, New South Wales, Australia

Singapore, , Singapore

Christchurch, , New Zealand

Leeds, , United Kingdom

Westmead, New South Wales, Australia

Stockholm, , Sweden

Kuopio, , Finland

Stavanger, , Norway

Gothenburg, , Sweden

Oulu, , Finland

Zürich, , Switzerland

Kuopio, , Finland

Tampere, , Finland

Newcastle, New South Wales, Australia

Sydney, New South Wales, Australia

Melbourne, Victoria, Australia

Wellington, , New Zealand

London, , United Kingdom

Oslo, , Norway

Brisbane, Queensland, Australia

Bristol, , United Kingdom

London, , United Kingdom

Helsingborg, , Sweden

Brisbane, Queensland, Australia

Karlstad, , Sweden

Ghent, , Belgium

Sydney, New South Wales, Australia

Luxembourg, , Luxembourg

Bern, , Switzerland

Liverpool, New South Wales, Australia

Riyadh, , Saudi Arabia

Lund, , Sweden

Helsingborg, Skåne, Sweden

Espoo, , Finland

Dublin, , Ireland

Umeå, , Sweden

Basildon, , United Kingdom

Solna, , Sweden

Malmö, , Sweden

Epping, Victoria, Australia

Cardiff, , United Kingdom

Sydney, New South Wales, Australia

Helsinki, , Finland

Lund, Skåne, Sweden

Malmö, Skåne, Sweden

Kingswood, New South Wales, Australia

Sydney, New South Wales, Australia

Melbourne, Victoria, Australia

Helsinki, , Finland

Halmstad, Halland, Sweden

Berlin, , Germany

Lübeck, , Germany

Saint Gallen, , Switzerland

London, , United Kingdom

Brussels, , Belgium

Lanaken, , Belgium

Tallinn, , Estonia

Helsinki, , Finland

Jyväskylä, , Finland

Tübingen, , Germany

Genova, , Italy

Auckland, , New Zealand

Auckland, , New Zealand

Auckland, , New Zealand

Northland, , New Zealand

Arendal, , Norway

Kalnes, , Norway

Skövde, , Sweden

Patients applied

0 patients applied

Trial Officials

Niklas Nielsen, PhD

Study Chair

Lund University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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