Stepcare Extended Follow-up Substudy

Not Applicable

Recruiting

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

• Registration Number: NCT06207942
• Lead Sponsor: Region Skane

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.

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.

Study Timeline

• Study Start: 2023-08-01
• Study First Submitted: 2024-01-05
• Study First Submitted QC: 2024-01-05
• Study First Posted: 2024-01-17
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-17
• Last Update Posted: 2025-04-23
• Primary Completion: 2027-01
• Study Completion: 2027-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Zarit Burden Interview (ZBI)	6 months	Caregiver burden for caregivers to out of hospital cardiac arrest survivors. Score range 0-88. Higher scores= worse indicating more caregiver burden
Montreal Cognitive Assessment (MoCA)	6 months	Cognitive function for out of hospital cardiac arrest survivors. Score range. Higher scores=better cognition

Trial Locations

Locations (34)

St George hospital; 🇦🇺 Kogarah, Australia

Austin hospital; 🇦🇺 Melbourne, Australia

Ziekenhuis Oost Limburg; 🇧🇪 Genk, Belgium

Ghent university hospital; 🇧🇪 Ghent, Belgium

Jorvi hospital; 🇫🇮 Jorvi, Finland

Charite university hospital; 🇩🇪 Berlin, Germany

Tubingen university hospital; 🇩🇪 Tubingen, Germany

Auckland city hospital; 🇳🇿 Auckland, New Zealand

Sorlandet hospital; 🇳🇴 Arendal, Norway

Bern university hospital; 🇨🇭 Bern, Switzerland

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