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Recruiting NCT06207942

NCT06207942 Stepcare Extended Follow-up Substudy

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Clinical Trial Summary
NCT ID NCT06207942
Status Recruiting
Phase
Sponsor Region Skane
Condition Cardiac Arrest With Successful Resuscitation
Study Type INTERVENTIONAL
Enrollment 600 participants
Start Date 2023-08-01
Primary Completion 2027-01

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age N/A
Study Type INTERVENTIONAL
Interventions
Feed back controlled temperature deviceHigh MAPDeep sedation

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 600 participants in total. It began in 2023-08-01 with a primary completion date of 2027-01.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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 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.

Contact & Investigator

Central Contact

Gisela Lilja, PhD

✉ gisela.lilja@med.lu.se

📞 +4646176393

Frequently Asked Questions

Who can join the NCT06207942 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, studying Cardiac Arrest With Successful Resuscitation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT06207942 currently recruiting?

Yes, NCT06207942 is actively recruiting participants. Contact the research team at gisela.lilja@med.lu.se for enrollment information.

Where is the NCT06207942 trial being conducted?

This trial is being conducted at Brisbane, Australia, Caringbah, Australia, Chermside, Australia, Kingswood, Australia and 11 additional locations.

Who is sponsoring the NCT06207942 clinical trial?

NCT06207942 is sponsored by Region Skane. The trial plans to enroll 600 participants.

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