Stepcare Extended Follow-up Substudy

Cognitive Impairment Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

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

• NCT number: NCT06207942
• Study type: Interventional
• Source: Region Skane
• Contact: Gisela Lilja, PhD
• Phone: +4646176393
• Email: gisela.lilja@med.lu.se
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2023
• Completion date: December 31, 2026