Sedation, Temperature and Pressure After Cardiac Arrest and Resuscitation
Status: Recruiting
Location: See all (56) locations...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Australia
Princess Alexandra Hospital
RECRUITING
Brisbane
The Prince Charles Hospital
RECRUITING
Brisbane
Nepean Hospital
RECRUITING
Kingswood
Liverpool Hospital
RECRUITING
Liverpool
Austin Hospital
RECRUITING
Melbourne
Royal North Shore Hospital
RECRUITING
Sydney
St George Hospital
RECRUITING
Sydney
The Sutherland Hospital
RECRUITING
Sydney
Belgium
HUB Hôpital Erasme
RECRUITING
Brussels
Ghent University Hospital
RECRUITING
Ghent
Ziekenhuis Oost-Limburg Hospital
RECRUITING
Lanaken
Estonia
North Estonia Medical Centre, Tallinn
RECRUITING
Tallinn
Finland
Jorvi Hospital
RECRUITING
Espoo
Helsinki Helsingforgs University Central Hospital
RECRUITING
Helsinki
Meilahti Hospital
RECRUITING
Helsinki
Jyväskylä Hospital
RECRUITING
Jyväskylä
Kuopio University Hospital
RECRUITING
Kuopio
Oulu University Hospital
RECRUITING
Oulu
Tampere University Hospital
RECRUITING
Tampere
Germany
Charite University Hospital
RECRUITING
Berlin
Lübeck University Hospital
RECRUITING
Lübeck
Tubingen University Hospital
RECRUITING
Tübingen
Ireland
St Vincents University Hospital
ACTIVE_NOT_RECRUITING
Dublin
Italy
San Martino Hospital Genova
RECRUITING
Genova
Luxembourg
Centre Hospitalier de Luxembourg
RECRUITING
Luxembourg
New Zealand
DCCM ICU
RECRUITING
Auckland
Middlemore ICU
RECRUITING
Auckland
North Shore ICU NZ
RECRUITING
Auckland
Christchurch Hospital
RECRUITING
Christchurch
Whangarei ICU
ACTIVE_NOT_RECRUITING
Northland
Wellington Hospital
RECRUITING
Wellington
Norway
Soerlandet Hospital Arendal
RECRUITING
Arendal
Kalnes Hospital
RECRUITING
Kalnes
Oslo University Hospital
RECRUITING
Oslo
Stavanger University Hospital
RECRUITING
Stavanger
Saudi Arabia
King Abdulaziz Medical City
RECRUITING
Riyadh
Singapore
Tan Tock Seng Hospital
RECRUITING
Singapore
Sweden
Sahlgrenska University Hospital
RECRUITING
Gothenburg
Hallands hospital
RECRUITING
Halmstad
Helsingborg Hospital
RECRUITING
Helsingborg
Karlstad hospital
RECRUITING
Karlstad
Skåne University Hospital
RECRUITING
Lund
Skåne University Hospital Malmö
RECRUITING
Malmo
Skaraborg Hospital Skovde
RECRUITING
Skövde
Karolinska University Hospital
RECRUITING
Stockholm
University Hospital of Umeå
RECRUITING
Umeå
Switzerland
Bern University Hospital
RECRUITING
Bern
St Gallen Hospital
RECRUITING
Sankt Gallen
University Hospital Zürich
RECRUITING
Zurich
United Kingdom
Essex Cardiothoracic Centre
RECRUITING
Basildon
Bristol Royal Infirmary
RECRUITING
Bristol
Cardiff University Hospital
RECRUITING
Cardiff
Leeds General Infirmary
RECRUITING
Leeds
Kings College Hospital
RECRUITING
London
St Bartholomew's Hospital
RECRUITING
London
St Georges University Hospital
RECRUITING
London
Contact Information
Primary
Josef Dankiewicz, PhD
josef.dankiewicz@med.lu.se
+464671000
Backup
Niklas Nielsen, PhD
niklas.nielsen@med.lu.se
+46424061000
Time Frame
Start Date: 2023-08-17
Estimated Completion Date: 2026-12
Participants
Target number of participants: 3500
Treatments
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.
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.
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.
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.
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.
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.
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.
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.
Related Therapeutic Areas
Sponsors
Collaborators: Copenhagen Trial Unit, Center for Clinical Intervention Research, Medical Research Institute of New Zealand Rangahautia Te Ora, Wellington, New Zealand, The George Institute for Global Health, Australia, Lund University, Lund, Sweden, HUS Helsinki University Hospitals, Helsinki, Finland, University Hospital of Wales
Leads: Region Skane