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Recruiting NCT06207942

Stepcare Extended Follow-up Substudy

Trial Parameters

Condition Cardiac Arrest With Successful Resuscitation
Sponsor Region Skane
Study Type INTERVENTIONAL
Phase N/A
Enrollment 600
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2023-08-01
Completion 2027-01
Interventions
Feed back controlled temperature deviceHigh MAPDeep sedation

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.

Eligibility Criteria

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

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