Status:
RECRUITING
Stepcare Extended Follow-up Substudy
Lead Sponsor:
Region Skane
Collaborating Sponsors:
Lund University
The George Institute for Global Health, Australia
Conditions:
Cardiac Arrest With Successful Resuscitation
Hypoxia, Brain
Eligibility:
All Genders
18+ years
Phase:
NA
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 p...
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 (C...
Eligibility Criteria
Inclusion
- All OHCA participants randomized in the STEPCARE trial at the extended follow-up participating sites, who survive and provide consent, with no further inclusion or exclusion criteria.
- The inclusion and exclusion criteria for the STEPCARE trial are:
- Inclusion criteria: out-of-hospital cardiac arrest of non-traumatic origin, minimum of 20 minutes without chest compressions (defined as stable return of spontaneous circulation. ROSC), unconsciousness (defined as not being able to obey verbal commands equal to a FOUR-score motor response of \<4, or being intubated and sedated because of agitation after sustained ROSC, eligible for intensive care without restrictions or limitation, inclusion within 4 hours (240 minutes) of ROSC (or 220 minutes of stable ROSC).
- Exclusion criteria: on ECMO prior to randomization, pregnancy, suspected or confirmed intracranial hemorrhage, previously randomized in the STEPCARE trial.
- 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.
Exclusion
Key Trial Info
Start Date :
August 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2027
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT06207942
Start Date
August 1 2023
End Date
July 31 2027
Last Update
April 23 2025
Active Locations (34)
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1
Princess Alexandra Hospital
Brisbane, Australia
2
The Sutherland Hospital
Caringbah, Australia
3
The Prince Charles Hospital
Chermside, Australia
4
Nepean hospital
Kingswood, Australia