Stepcare Extended Follow-up Substudy

Region Skane

Status: Enrolling

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

Treatments: Other: Low MAP; Other: Minimal sedation; Other: High MAP; Device: Feed back controlled temperature device; Other: Fever control without a device; Other: Deep sedation

Study type: Interventional

Funder types: Other

Identifiers

NCT06207942

extfustep2024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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600 participants in 8 patient groups

Sedation, temperature device and high MAP

Active Comparator group

Treatment:

Other: Deep sedation

Device: Feed back controlled temperature device

Other: High MAP

Sedation, no temperature device and high MAP

Active Comparator group

Treatment:

Other: Deep sedation

Other: Fever control without a device

Other: High MAP

Sedation, temperature device and low MAP

Active Comparator group

Treatment:

Other: Deep sedation

Device: Feed back controlled temperature device

Other: Low MAP

Sedation, no temperature device, and low MAP

Active Comparator group

Treatment:

Other: Deep sedation

Other: Fever control without a device

Other: Low MAP

Minimal sedation, temperature device, and high MAP

Active Comparator group

Treatment:

Device: Feed back controlled temperature device

Other: High MAP

Other: Minimal sedation

Minimal sedation, no temperature device and high MAP

Active Comparator group

Treatment:

Other: Fever control without a device

Other: High MAP

Other: Minimal sedation

Minimal sedation, temperature device and low MAP

Active Comparator group

Treatment:

Device: Feed back controlled temperature device

Other: Minimal sedation

Other: Low MAP

Minimal sedation, no temperature device and low MAP

Active Comparator group

Treatment:

Other: Fever control without a device

Other: Minimal sedation

Other: Low MAP