NCT06207942

Stepcare Extended Follow-up Substudy

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: Region Skane · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This extended follow-up substudy is incorporated into the multi-center, international, factorial randomized Sedation, Temperature and Pressure after Cardiac Arrest and Resuscitation -STEPCARE trial (Clinical trials identifier:NCT05564754) were out of hospital cardiac arrest participants will be randomized to different targets of sedation, temperature, and MAP management. Only selected STEPCARE sites will participate in this extended follow-up substudy. At the extended follow up participating sites all out of hospital cardiac arrest participants randomized in the STEPCARE trial, who survive and provide consent, will be eligible to participate in this substudy, with no further inclusion or exclusion criteria.The extended follow-up substudy is estimated to enroll approximately 600 post OHCA survivors. One nominated caregiver per post OHCA survivor will be invited to be included in the study. Participants will be followed up at 6 and 12 months. The primary outcome for this extended follow up substudy is cognitive function at 6 months for the out of hospital cardiac arrest survivors andCaregiver burden at 6 months for the caregivers.

Conditions

• Cardiac Arrest With Successful Resuscitation
• Hypoxia, Brain
• Cognitive Impairment
• Caregiver Burden

Interventions

Type	Name	Description
DEVICE	Feed back controlled temperature device	If core temperature exceeds 37.7 degrees celsius a feedback controlled-device will be used at set to 37.5 degrees celsius
OTHER	High MAP	A mean arterial blood pressure (MAP) of \>85mmHg will be used. Vasopressors will be titrated to this target during 36 hours
OTHER	Deep sedation	Deep sedation for at least 36 hours
OTHER	Fever control without a device	Management of fever in the intensive care unit without a device
OTHER	Low MAP	A mean arterial blood pressure (MAP) of \>65mmHG will be used. Vasopressors will be titrated to this target during 36 hours
OTHER	Minimal sedation	A strategy of minimal sedation in the intensive care unit, used only as needed to facilitate transport, imaging and invasive procedures

Timeline

• Start date: 2023-08-01
• Primary completion: 2027-01-01
• Completion: 2027-07-31
• First posted: 2024-01-17
• Last updated: 2025-04-23

Locations

34 sites across 10 countries: Australia, Belgium, Finland, Germany, Luxembourg, New Zealand, Norway, Sweden, Switzerland, United Kingdom