Clinical trial NCT06207942: Stepcare Extended Follow-up Substudy
Official title: Extended Follow-up Substudy of the Sedation, Temperature and Pressure After Cardiac Arrest and Resuscitation -STEPCARE Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiac Arrest With Successful Resuscitation
Hypoxia, Brain
Cognitive Impairment
Caregiver Burden
Lead sponsor: Region Skane
Sponsor class: OTHER
Collaborators: name: Lund University
name: The George Institute for Global Health, Australia
name: Copenhagen Trial Unit, Center for Clinical Intervention Research
name: Helsinki University Central Hospital
First posted: 2024-01-17
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 2X2X2 factorial., with all participants taking part in each factor
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: 6 months
measure: Zarit Burden Interview (ZBI)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
measure: Symbol Digit Modalities Test (SDMT)
timeFrame: 6 and 12 months
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 6 and 12 months
measure: Post Posttraumatic Stress Disorders Checklist updated for DSM-5 (PCL-5)
timeFrame: 6 and 12 months
measure: Modified Fatigue Impact Scale (MFIS)
timeFrame: 6 and 12 months
measure: modified Rankin Scale (mRS)
timeFrame: 12 months
measure: World Health Organization Disability Assessment (WHODAS) 2.0
timeFrame: 6 and 12 months
measure: Return to work
timeFrame: 6 and 12 months
measure: EuroQol health survey 5 dimensions 5 levels response version (EQ-5D-5L)
timeFrame: 12 months for out of hospital cardiac arrest survivors. 6 and 12 months for caregiver
measure: Life satisfaction visual analogue scale from the World Value Survey
timeFrame: 6 and 12 months
measure: Timed Stands Test (TST)
timeFrame: 6 and 12 months
measure: Jamar hand grip dynamometer
timeFrame: 6 and 12 months
Locations:
city: Brisbane
country: Australia
facility: Princess Alexandra Hospital
city: Caringbah
country: Australia
facility: The Sutherland Hospital
city: Chermside
country: Australia
facility: The Prince Charles Hospital
city: Kingswood
country: Australia
facility: Nepean hospital
city: Kogarah
country: Australia
facility: St George hospital
city: Liverpool
country: Australia
facility: Liverpool hospital
city: Melbourne
country: Australia
facility: Austin hospital
city: Sydney
country: Australia
facility: Royal North Shore Hospital
city: Genk
country: Belgium
facility: Ziekenhuis Oost Limburg
city: Ghent
country: Belgium
facility: Ghent university hospital
city: Helsinki
country: Finland
facility: Helsinki Helsingfors university central hospital
city: Jorvi
country: Finland
facility: Jorvi hospital
city: Tampere
country: Finland
facility: Tampere university hospital
city: Berlin
country: Germany
facility: Charite university hospital
city: Lübeck
country: Germany
facility: Universitäres Herzzentrum Lübeck Universitätsklinikum Schleswig-Holstein
city: Tubingen
country: Germany
facility: Tubingen university hospital
city: Luxembourg
country: Luxembourg
facility: Centre Hospitalier de Luxembourg
city: Auckland
country: New Zealand
facility: Auckland city hospital
city: Auckland
country: New Zealand
facility: Middlemore hospital
city: Christchurch
country: New Zealand
facility: Christchurch hospital
city: Wellington
country: New Zealand
facility: Wellington hospital
city: Arendal
country: Norway
facility: Sorlandet hospital
city: Oslo
country: Norway
facility: Oslo university hospital Rikshospitalet
city: Gothenburg
country: Sweden
facility: Sahlgrenska university hospital
city: Halland
country: Sweden
facility: Hallands hospital
city: Helsingborg
country: Sweden
facility: Helsingborg hospital
city: Lund
country: Sweden
facility: Skåne university hospital
city: Malmö
country: Sweden
facility: Skåne university hopsital
city: Bern
country: Switzerland
facility: Bern university hospital
city: Saint Gallen
country: Switzerland
facility: Kantonsspital St. Gallen
city: Basildon
country: United Kingdom
facility: The Essex Cardiothoracic Centre
city: Bristol
country: United Kingdom
facility: Bristol Royal Infirmary
city: Cardiff
country: United Kingdom
facility: University hospital of Wales
city: London
country: United Kingdom
facility: St Bartholomew's hospital
Study officials:
References: