Sedation, Temperature and Pressure After Cardiac Arrest and Resuscitation
NCT ID: NCT05564754
Last Updated: 2025-07-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
3500 participants
INTERVENTIONAL
2023-08-17
2026-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
TRIPLE
Study Groups
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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.
Feedback-controlled temperature device
If core body temperature exceeds 37.7°C a feedback controlled-device will be used and set at 37.5°C.
High MAP
A MAP target of \>85mmHg will be used. Vasopressors will be titrated to this target during 36h.
Deep sedation
Deep sedation for at least 36h
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.
High MAP
A MAP target of \>85mmHg will be used. Vasopressors will be titrated to this target during 36h.
Deep sedation
Deep sedation for at least 36h
Fever control without a device
Management of fever in the ICU without a device
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.
Feedback-controlled temperature device
If core body temperature exceeds 37.7°C a feedback controlled-device will be used and set at 37.5°C.
Deep sedation
Deep sedation for at least 36h
Low MAP
A MAP target of \>65mmHg will be used. Vasopressors will be titrated to this target during 36h.
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.
Deep sedation
Deep sedation for at least 36h
Fever control without a device
Management of fever in the ICU without a device
Low MAP
A MAP target of \>65mmHg will be used. Vasopressors will be titrated to this target during 36h.
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.
Feedback-controlled temperature device
If core body temperature exceeds 37.7°C a feedback controlled-device will be used and set at 37.5°C.
High MAP
A MAP target of \>85mmHg will be used. Vasopressors will be titrated to this target during 36h.
Minimal sedation
A strategy of minimal sedation in the ICU, used only as needed to facilitate transport, imaging and invasive procedures.
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.
High MAP
A MAP target of \>85mmHg will be used. Vasopressors will be titrated to this target during 36h.
Fever control without a device
Management of fever in the ICU without a device
Minimal sedation
A strategy of minimal sedation in the ICU, used only as needed to facilitate transport, imaging and invasive procedures.
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.
Feedback-controlled temperature device
If core body temperature exceeds 37.7°C a feedback controlled-device will be used and set at 37.5°C.
Low MAP
A MAP target of \>65mmHg will be used. Vasopressors will be titrated to this target during 36h.
Minimal sedation
A strategy of minimal sedation in the ICU, used only as needed to facilitate transport, imaging and invasive procedures.
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.
Fever control without a device
Management of fever in the ICU without a device
Low MAP
A MAP target of \>65mmHg will be used. Vasopressors will be titrated to this target during 36h.
Minimal sedation
A strategy of minimal sedation in the ICU, used only as needed to facilitate transport, imaging and invasive procedures.
Interventions
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Feedback-controlled temperature device
If core body temperature exceeds 37.7°C a feedback controlled-device will be used and set at 37.5°C.
High MAP
A MAP target of \>85mmHg will be used. Vasopressors will be titrated to this target during 36h.
Deep sedation
Deep sedation for at least 36h
Fever control without a device
Management of fever in the ICU without a device
Low MAP
A MAP target of \>65mmHg will be used. Vasopressors will be titrated to this target during 36h.
Minimal sedation
A strategy of minimal sedation in the ICU, used only as needed to facilitate transport, imaging and invasive procedures.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Lund University, Lund, Sweden
UNKNOWN
Copenhagen Trial Unit, Center for Clinical Intervention Research
OTHER
The George Institute for Global Health, Australia
OTHER
HUS Helsinki University Hospitals, Helsinki, Finland
UNKNOWN
Medical Research Institute of New Zealand Rangahautia Te Ora, Wellington, New Zealand
UNKNOWN
University Hospital of Wales
OTHER
Region Skane
OTHER
Responsible Party
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Principal Investigators
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Niklas Nielsen, PhD
Role: STUDY_CHAIR
Lund University
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Ian Seppelt, Dr
Role: primary
Antony Stewart, Dr.
Role: primary
Wade Stedman, Dr
Role: primary
Manoj Saxena, Dr
Role: primary
Anas Naeem, Dr
Role: primary
James Walsham, Dr
Role: primary
Denzil Gill, Dr
Role: primary
Rinaldo Bellomo, Prof
Role: primary
Markus Skrifvars, PhD
Role: primary
Matti Reinikainen, PhD
Role: primary
Pascal Stammet, MD, PdH
Role: primary
Paul Young
Role: primary
Johan Undén, MD, PhD
Role: primary
Jesper Johnsson, MD,PhD
Role: primary
Anna Lybeck, MD,PhD
Role: primary
Joachim Düring, MD,PhD
Role: primary
Related Links
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Trial webpage
Other Identifiers
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step2022
Identifier Type: -
Identifier Source: org_study_id
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