Share
Save
Stepcare Extended Follow-up Substudy
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.
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2023-08-01
Primary completion: 2026-06-30
Study completion finish: 2026-12-31
Study type
TREATMENT
Phase
NA
Trial ID
NCT06207942
Intervention or treatment
DEVICE: Feed back controlled temperature device
OTHER: High MAP
OTHER: Deep sedation
OTHER: Fever control without a device
OTHER: Low MAP
OTHER: Minimal sedation
Conditions
- • Cognitive Impairment
- • Cardiac Arrest With Successful Resuscitation
- • Hypoxia, Brain
- • Caregiver Burden
Find a site
Closest Location:
Princess Alexandra Hospital
Research sites nearby
Select from list below to view details:
Princess Alexandra Hospital
Brisbane, Not Specified, Australia
The Prince Charles Hospital
Chermside, Not Specified, Australia
The Sutherland Hospital
Caringbah, Not Specified, Australia
Nepean hospital
Kingswood, Not Specified, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ACTIVE_COMPARATOR: Sedation, temperature device and high MAP
| DEVICE: Feed back controlled temperature device
|
ACTIVE_COMPARATOR: Sedation, no temperature device and high MAP
| OTHER: High MAP
|
ACTIVE_COMPARATOR: Sedation, temperature device and low MAP
| DEVICE: Feed back controlled temperature device
|
ACTIVE_COMPARATOR: Sedation, no temperature device, and low MAP
| OTHER: Deep sedation
|
ACTIVE_COMPARATOR: Minimal sedation, temperature device, and high MAP
| DEVICE: Feed back controlled temperature device
|
ACTIVE_COMPARATOR: Minimal sedation, no temperature device and high MAP
| OTHER: High MAP
|
ACTIVE_COMPARATOR: Minimal sedation, temperature device and low MAP
| DEVICE: Feed back controlled temperature device
|
ACTIVE_COMPARATOR: Minimal sedation, no temperature device and low MAP
| OTHER: Fever control without a device
|
What is the study measuring?
Primary outcome
| Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
|---|---|---|
| Montreal Cognitive Assessment (MoCA) | Cognitive function for out of hospital cardiac arrest survivors. Score range. Higher scores=better cognition | 6 months |
| Zarit Burden Interview (ZBI) | Caregiver burden for caregivers to out of hospital cardiac arrest survivors. Score range 0-88. Higher scores= worse indicating more caregiver burden | 6 months |
Secondary outcome
Frequently Asked Questions
Please note: some questions and answers are submitted by anonymous patients or using AI, and have not been verified by Clinrol
No questions submitted. Be the first to ask a question!