Long-term follow-up for cardiac arrest survivors and their caregivers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This substudy aims to gather detailed information on the long-term outcomes of survivors of out-of-hospital cardiac arrest, focusing on cognitive function and caregiver burden at 6 and 12 months post-resuscitation. Participants will be part of the larger STEPCARE trial, which investigates different management strategies for sedation, temperature, and blood pressure after cardiac arrest. Approximately 600 survivors and their nominated caregivers will be enrolled, with follow-ups conducted to assess recovery and the impact on caregivers. The study will utilize various interventions, including temperature control and sedation management.

Why it matters

Who can join: the full rules

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.

Where it's running

• Princess Alexandra Hospital
  Brisbane, Australia Recruiting
• The Sutherland Hospital
  Caringbah, Australia Recruiting
• The Prince Charles Hospital
  Chermside, Australia Recruiting
• Nepean hospital
  Kingswood, Australia Recruiting
• St George hospital
  Kogarah, Australia Recruiting
• Liverpool hospital
  Liverpool, Australia Recruiting

Study contacts

• Study coordinator: Gisela Lilja, PhD
• Email: gisela.lilja@med.lu.se
• Phone: +4646176393

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.