Home › Trials › NCT06207942

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

Extended Follow-up Substudy of the Sedation, Temperature and Pressure After Cardiac Arrest and Resuscitation -STEPCARE Trial

Not applicable Interventional Region Skane · NCT06207942

This study is testing how well survivors of out-of-hospital cardiac arrest recover over time and how it affects their caregivers, with a focus on their thinking skills and overall well-being.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment600 (estimated)
Ages18 Years and up
SexAll
SponsorRegion Skane Academic / other
Locations34 sites (Brisbane and 33 other locations)
Trial IDNCT06207942 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include survivors of out-of-hospital cardiac arrest who have provided consent and are participating in the STEPCARE trial.

Not a fit: Patients who do not survive the initial cardiac arrest or those with conditions like pregnancy or intracranial hemorrhage may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved recovery strategies for cardiac arrest survivors and better support for their caregivers.

How similar studies have performed: Other studies have shown promise in improving outcomes for cardiac arrest survivors through targeted management strategies, suggesting potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Brisbane and 33 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Cardiac Arrest With Successful ResuscitationHypoxia, BrainCognitive ImpairmentCaregiver Burden
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.