Stepcare Extended Follow-up Substudy
Extended Follow-up Substudy of the Sedation, Temperature and Pressure After Cardiac Arrest and Resuscitation -STEPCARE Trial
1 other identifier
interventional
600
10 countries
34
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2023
Longer than P75 for not_applicable
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2023
CompletedFirst Submitted
Initial submission to the registry
January 5, 2024
CompletedFirst Posted
Study publicly available on registry
January 17, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2027
April 23, 2025
April 1, 2025
3.4 years
January 5, 2024
April 17, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Montreal Cognitive Assessment (MoCA)
Cognitive function for out of hospital cardiac arrest survivors. Score range. Higher scores=better cognition
6 months
Zarit Burden Interview (ZBI)
Caregiver burden for caregivers to out of hospital cardiac arrest survivors. Score range 0-88. Higher scores= worse indicating more caregiver burden
6 months
Other Outcomes (11)
Symbol Digit Modalities Test (SDMT)
6 and 12 months
Hospital Anxiety and Depression Scale (HADS)
6 and 12 months
Post Posttraumatic Stress Disorders Checklist updated for DSM-5 (PCL-5)
6 and 12 months
- +8 more other outcomes
Study Arms (8)
Sedation, temperature device and high MAP
ACTIVE COMPARATORSedation, no temperature device and high MAP
ACTIVE COMPARATORSedation, temperature device and low MAP
ACTIVE COMPARATORSedation, no temperature device, and low MAP
ACTIVE COMPARATORMinimal sedation, temperature device, and high MAP
ACTIVE COMPARATORMinimal sedation, no temperature device and high MAP
ACTIVE COMPARATORMinimal sedation, temperature device and low MAP
ACTIVE COMPARATORMinimal sedation, no temperature device and low MAP
ACTIVE COMPARATORInterventions
If core temperature exceeds 37.7 degrees celsius a feedback controlled-device will be used at set to 37.5 degrees celsius
A mean arterial blood pressure (MAP) of \>85mmHg will be used. Vasopressors will be titrated to this target during 36 hours
Deep sedation for at least 36 hours
Management of fever in the intensive care unit without a device
A mean arterial blood pressure (MAP) of \>65mmHG will be used. Vasopressors will be titrated to this target during 36 hours
A strategy of minimal sedation in the intensive care unit, used only as needed to facilitate transport, imaging and invasive procedures
Eligibility Criteria
You may not qualify if:
- For caregivers, the eligibility will be that they live with, or have weekly or more frequent contact (in person or over the telephone) with the post OHCA survivor. Only one nominated caregiver per post OHCA survivor will be able to be included in the study. This would typically be the caregiver that would identify as the primary caregiver of the post OHCA survivor if needed, but may also be another close family member.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Region Skanelead
- Lund Universitycollaborator
- The George Institute for Global Health, Australiacollaborator
- Copenhagen Trial Unit, Center for Clinical Intervention Researchcollaborator
- Helsinki University Central Hospitalcollaborator
Study Sites (34)
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
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Participants (out of hospital cardiac arrest survivors and caregivers) will be blinded. Assessors of neurological prognosis will be blinded. Outcome assessors and investigators will be blinded.
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 5, 2024
First Posted
January 17, 2024
Study Start
August 1, 2023
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
July 31, 2027
Last Updated
April 23, 2025
Record last verified: 2025-04