Stepcare Extended Follow-up Substudy

Launched by REGION SKANE · Jan 5, 2024

Keywords

ClinConnect Summary

The Stepcare Extended Follow-up Substudy is a clinical trial that looks at the long-term recovery of patients who have survived a cardiac arrest outside of a hospital. Specifically, it focuses on how different methods of managing sedation, body temperature, and blood pressure after the event can affect brain health and overall recovery after 6 and 12 months. The study also aims to understand the challenges and burdens faced by caregivers who look after these survivors, as their well-being is important too.

To be eligible for this trial, participants must have been part of the earlier STEPCARE trial and survived a non-traumatic out-of-hospital cardiac arrest for at least 20 minutes without chest compressions. They should also be able to give their consent to participate. Caregivers who are closely involved with the survivor, either living with them or having regular contact, can also take part in the study. Participants can expect to share their experiences and receive support as researchers gather important information on recovery and caregiving challenges over time. This trial is currently recruiting, and both patients and caregivers are encouraged to consider joining to help improve care for future survivors.

Gender

ALL

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 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.