Stepcare Extended Follow-up Substudy
- Conditions
- Cardiac Arrest With Successful ResuscitationCognitive ImpairmentHypoxia, BrainCaregiver Burden
- Interventions
- Device: Feed back controlled temperature deviceOther: Fever control without a deviceOther: High MAPOther: Deep sedationOther: Low MAPOther: Minimal sedation
- Registration Number
- NCT06207942
- Lead Sponsor
- Region Skane
- Brief Summary
To provide detailed information on long-term outcomes in relation to potential neuroprotection and improvements in recovery for different targets of sedation, temperature, and pressure management in post out of hospital cardiac arrest survivors at 6 and 12 months. In addition, the impact of caring for a post OHCA survivor will be explored.
- Detailed Description
This extended follow-up substudy is incorporated into the multi-center, international, factorial randomized Sedation, Temperature and Pressure after Cardiac Arrest and Resuscitation -STEPCARE trial (Clinical trials identifier:NCT05564754) were out of hospital cardiac arrest participants will be randomized to different targets of sedation, temperature, and MAP management.
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 600
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Sedation, no temperature device, and low MAP Fever control without a device - Minimal sedation, temperature device, and high MAP Feed back controlled temperature device - Sedation, temperature device and high MAP Deep sedation - Sedation, temperature device and low MAP Low MAP - Minimal sedation, temperature device and low MAP Feed back controlled temperature device - Sedation, no temperature device and high MAP Deep sedation - Sedation, temperature device and low MAP Deep sedation - Sedation, no temperature device and high MAP Fever control without a device - Sedation, no temperature device, and low MAP Low MAP - Sedation, temperature device and high MAP Feed back controlled temperature device - Sedation, temperature device and high MAP High MAP - Sedation, no temperature device, and low MAP Deep sedation - Minimal sedation, temperature device, and high MAP High MAP - Minimal sedation, no temperature device and high MAP High MAP - Sedation, no temperature device and high MAP High MAP - Sedation, temperature device and low MAP Feed back controlled temperature device - Minimal sedation, no temperature device and high MAP Fever control without a device - Minimal sedation, temperature device and low MAP Minimal sedation - Minimal sedation, temperature device, and high MAP Minimal sedation - Minimal sedation, no temperature device and low MAP Low MAP - Minimal sedation, no temperature device and low MAP Minimal sedation - Minimal sedation, no temperature device and high MAP Minimal sedation - Minimal sedation, temperature device and low MAP Low MAP - Minimal sedation, no temperature device and low MAP Fever control without a device -
- Primary Outcome Measures
Name Time Method Zarit Burden Interview (ZBI) 6 months Caregiver burden for caregivers to out of hospital cardiac arrest survivors. Score range 0-88. Higher scores= worse indicating more caregiver burden
Montreal Cognitive Assessment (MoCA) 6 months Cognitive function for out of hospital cardiac arrest survivors. Score range. Higher scores=better cognition
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (34)
Hallands hospital
🇸🇪Halland, Sweden
St George hospital
🇦🇺Kogarah, Australia
Austin hospital
🇦🇺Melbourne, Australia
Ziekenhuis Oost Limburg
🇧🇪Genk, Belgium
Ghent university hospital
🇧🇪Ghent, Belgium
Jorvi hospital
🇫🇮Jorvi, Finland
Charite university hospital
🇩🇪Berlin, Germany
Tubingen university hospital
🇩🇪Tubingen, Germany
Auckland city hospital
🇳🇿Auckland, New Zealand
Sorlandet hospital
🇳🇴Arendal, Norway
Bern university hospital
🇨🇭Bern, Switzerland
The Essex Cardiothoracic Centre
🇬🇧Basildon, United Kingdom
Bristol Royal Infirmary
🇬🇧Bristol, United Kingdom
St Bartholomew's hospital
🇬🇧London, United Kingdom
Princess Alexandra Hospital
🇦🇺Brisbane, Australia
The Sutherland Hospital
🇦🇺Caringbah, Australia
The Prince Charles Hospital
🇦🇺Chermside, Australia
Nepean hospital
🇦🇺Kingswood, Australia
Liverpool hospital
🇦🇺Liverpool, Australia
Helsinki Helsingfors university central hospital
🇫🇮Helsinki, Finland
Tampere university hospital
🇫🇮Tampere, Finland
Universitäres Herzzentrum Lübeck Universitätsklinikum Schleswig-Holstein
🇩🇪Lübeck, Germany
Royal North Shore Hospital
🇦🇺Sydney, Australia
Centre Hospitalier de Luxembourg
🇱🇺Luxembourg, Luxembourg
Middlemore hospital
🇳🇿Auckland, New Zealand
Christchurch hospital
🇳🇿Christchurch, New Zealand
Wellington hospital
🇳🇿Wellington, New Zealand
Oslo university hospital Rikshospitalet
🇳🇴Oslo, Norway
Sahlgrenska university hospital
🇸🇪Gothenburg, Sweden
Helsingborg hospital
🇸🇪Helsingborg, Sweden
Skåne university hospital
🇸🇪Lund, Sweden
Skåne university hopsital
🇸🇪Malmö, Sweden
Kantonsspital St. Gallen
🇨🇭Saint Gallen, Switzerland
University hospital of Wales
🇬🇧Cardiff, United Kingdom