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
600 participants
INTERVENTIONAL
2023-08-01
2027-07-31
Brief Summary
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Detailed Description
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Only selected STEPCARE sites will participate in this extended follow-up substudy. At the extended follow up participating sites all out of hospital cardiac arrest participants randomized in the STEPCARE trial, who survive and provide consent, will be eligible to participate in this substudy, with no further inclusion or exclusion criteria.The extended follow-up substudy is estimated to enroll approximately 600 post OHCA survivors. One nominated caregiver per post OHCA survivor will be invited to be included in the study.
Participants will be followed up at 6 and 12 months.
The primary outcome for this extended follow up substudy is cognitive function at 6 months for the out of hospital cardiac arrest survivors andCaregiver burden at 6 months for the caregivers.
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
Feed back controlled temperature device
If core temperature exceeds 37.7 degrees celsius a feedback controlled-device will be used at set to 37.5 degrees celsius
High MAP
A mean arterial blood pressure (MAP) of \>85mmHg will be used. Vasopressors will be titrated to this target during 36 hours
Deep sedation
Deep sedation for at least 36 hours
Sedation, no temperature device and high MAP
High MAP
A mean arterial blood pressure (MAP) of \>85mmHg will be used. Vasopressors will be titrated to this target during 36 hours
Deep sedation
Deep sedation for at least 36 hours
Fever control without a device
Management of fever in the intensive care unit without a device
Sedation, temperature device and low MAP
Feed back controlled temperature device
If core temperature exceeds 37.7 degrees celsius a feedback controlled-device will be used at set to 37.5 degrees celsius
Deep sedation
Deep sedation for at least 36 hours
Low MAP
A mean arterial blood pressure (MAP) of \>65mmHG will be used. Vasopressors will be titrated to this target during 36 hours
Sedation, no temperature device, and low MAP
Deep sedation
Deep sedation for at least 36 hours
Fever control without a device
Management of fever in the intensive care unit without a device
Low MAP
A mean arterial blood pressure (MAP) of \>65mmHG will be used. Vasopressors will be titrated to this target during 36 hours
Minimal sedation, temperature device, and high MAP
Feed back controlled temperature device
If core temperature exceeds 37.7 degrees celsius a feedback controlled-device will be used at set to 37.5 degrees celsius
High MAP
A mean arterial blood pressure (MAP) of \>85mmHg will be used. Vasopressors will be titrated to this target during 36 hours
Minimal sedation
A strategy of minimal sedation in the intensive care unit, used only as needed to facilitate transport, imaging and invasive procedures
Minimal sedation, no temperature device and high MAP
High MAP
A mean arterial blood pressure (MAP) of \>85mmHg will be used. Vasopressors will be titrated to this target during 36 hours
Fever control without a device
Management of fever in the intensive care unit without a device
Minimal sedation
A strategy of minimal sedation in the intensive care unit, used only as needed to facilitate transport, imaging and invasive procedures
Minimal sedation, temperature device and low MAP
Feed back controlled temperature device
If core temperature exceeds 37.7 degrees celsius a feedback controlled-device will be used at set to 37.5 degrees celsius
Low MAP
A mean arterial blood pressure (MAP) of \>65mmHG will be used. Vasopressors will be titrated to this target during 36 hours
Minimal sedation
A strategy of minimal sedation in the intensive care unit, used only as needed to facilitate transport, imaging and invasive procedures
Minimal sedation, no temperature device and low MAP
Fever control without a device
Management of fever in the intensive care unit without a device
Low MAP
A mean arterial blood pressure (MAP) of \>65mmHG will be used. Vasopressors will be titrated to this target during 36 hours
Minimal sedation
A strategy of minimal sedation in the intensive care unit, used only as needed to facilitate transport, imaging and invasive procedures
Interventions
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Feed back controlled temperature device
If core temperature exceeds 37.7 degrees celsius a feedback controlled-device will be used at set to 37.5 degrees celsius
High MAP
A mean arterial blood pressure (MAP) of \>85mmHg will be used. Vasopressors will be titrated to this target during 36 hours
Deep sedation
Deep sedation for at least 36 hours
Fever control without a device
Management of fever in the intensive care unit without a device
Low MAP
A mean arterial blood pressure (MAP) of \>65mmHG will be used. Vasopressors will be titrated to this target during 36 hours
Minimal sedation
A strategy of minimal sedation in the intensive care unit, used only as needed to facilitate transport, imaging and invasive procedures
Eligibility Criteria
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Exclusion Criteria
18 Years
ALL
No
Sponsors
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Lund University
OTHER
The George Institute for Global Health, Australia
OTHER
Copenhagen Trial Unit, Center for Clinical Intervention Research
OTHER
Helsinki University Central Hospital
OTHER
Region Skane
OTHER
Responsible Party
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Locations
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Princess Alexandra Hospital
Brisbane, , Australia
The Sutherland Hospital
Caringbah, , Australia
The Prince Charles Hospital
Chermside, , Australia
Nepean hospital
Kingswood, , Australia
St George hospital
Kogarah, , Australia
Liverpool hospital
Liverpool, , Australia
Austin hospital
Melbourne, , Australia
Royal North Shore Hospital
Sydney, , Australia
Ziekenhuis Oost Limburg
Genk, , Belgium
Ghent university hospital
Ghent, , Belgium
Helsinki Helsingfors university central hospital
Helsinki, , Finland
Jorvi hospital
Jorvi, , Finland
Tampere university hospital
Tampere, , Finland
Charite university hospital
Berlin, , Germany
Universitäres Herzzentrum Lübeck Universitätsklinikum Schleswig-Holstein
Lübeck, , Germany
Tubingen university hospital
Tübingen, , Germany
Centre Hospitalier de Luxembourg
Luxembourg, , Luxembourg
Auckland city hospital
Auckland, , New Zealand
Middlemore hospital
Auckland, , New Zealand
Christchurch hospital
Christchurch, , New Zealand
Wellington hospital
Wellington, , New Zealand
Sorlandet hospital
Arendal, , Norway
Oslo university hospital Rikshospitalet
Oslo, , Norway
Sahlgrenska university hospital
Gothenburg, , Sweden
Hallands hospital
Hålland, , Sweden
Helsingborg hospital
Helsingborg, , Sweden
Skåne university hospital
Lund, , Sweden
Skåne university hopsital
Malmo, , Sweden
Bern university hospital
Bern, , Switzerland
Kantonsspital St. Gallen
Sankt Gallen, , Switzerland
The Essex Cardiothoracic Centre
Basildon, , United Kingdom
Bristol Royal Infirmary
Bristol, , United Kingdom
University hospital of Wales
Cardiff, , United Kingdom
St Bartholomew's hospital
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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James Walsham
Role: primary
Frances Bass
Role: primary
Frances Bass
Role: primary
Ian Seppelt, Dr
Role: primary
Anthony Stewart, Dr
Role: primary
Frances Bass
Role: primary
Patrick Druwve
Role: primary
Marjaana Tiainen
Role: primary
Joonas Tirkkonen
Role: primary
Christoph Leithner
Role: primary
Tobias Graf
Role: primary
Pascal Stammet, MD, PhD
Role: primary
Paul Young
Role: primary
Paul Young
Role: primary
Paul Young
Role: primary
Louis Romundstad
Role: primary
Jonathan Oras
Role: primary
Andreas Lundin
Role: backup
Johan Unden, MD PhD
Role: primary
Jesper Johnsson, MD, PhD
Role: primary
Anna Lybeck, MD, PhD
Role: primary
Joachim During, MD, PhD
Role: primary
Manuela Itens
Role: primary
Claudia Schrag
Role: primary
Thomas Keeble
Role: primary
Matthew Thomas
Role: primary
Matt Wise
Role: primary
Nikolaos Gorgoraptis
Role: primary
Related Links
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Official STEPCARE trial website
Other Identifiers
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extfustep2024
Identifier Type: -
Identifier Source: org_study_id
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