Clinical trial NCT05564754: Sedation, Temperature and Pressure After Cardiac Arrest and Resuscitation
Official title: Sedation, Temperature and Pressure After Cardiac Arrest and Resuscitation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiac Arrest With Successful Resuscitation
Hypoxia, Brain
Lead sponsor: Region Skane
Sponsor class: OTHER
Collaborators: name: Lund University, Lund, Sweden
name: Copenhagen Trial Unit, Center for Clinical Intervention Research
name: The George Institute for Global Health, Australia
name: HUS Helsinki University Hospitals, Helsinki, Finland
name: Medical Research Institute of New Zealand Rangahautia Te Ora, Wellington, New Zealand
First posted: 2022-10-03
Enrollment: 3500
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 patients taking part in each factor.
Primary purpose: TREATMENT

Brief summary: The STEPCARE-trial is a 2x2x2 randomised trial studying patients who have been resuscitated from cardiac arrest and who are comatose. It will include three different interventions focusing on sedation targets, temperature targets and mean arterial pressure targets.

Detailed description: 3500 patients who are comatose after cardiac arrest will be included in a trial studying three separate targets. All patients will be randomised to a control or an intervention arm for sedation, temperature and blood pressure targets. These are.

1. Continuous deep sedation for 36 hours or minimal sedation (SEDCARE)
2. Fever management with or without a feedback-controlled device (TEMPCARE)
3. A mean arterial pressure target of \>85mmHg or \>65mmHg. (MAPCARE)

Participants will be followed up at 30 days and 6 months. The primary outcome will be survival at 6 months.

Eligibility criteria: Inclusion Criteria:

1. Out-of-hospital cardiac arrest
2. Sustained ROSC - defined as 20 minutes with signs of circulation without the need for chest compressions
3. Unconsciousness defined as not being able to obey verbal commands (FOUR-score motor response of \<4) or being intubated and sedated because of agitation after sustained ROSC.
4. Eligible for intensive care without restrictions or limitations
5. Inclusion within 4 hours of ROSC

Exclusion Criteria:

1. On ECMO prior to randomization
2. Pregnancy
3. Suspected or confirmed intracranial hemorrhage
4. Previously randomized in the STEPCARE trial.

Primary outcomes:
measure: Mortality
timeFrame: 6 months
Secondary outcomes:
measure: Functional outcome
timeFrame: 6 months
measure: Health-related quality of life
timeFrame: 6 months
Other outcomes:
measure: ICU stay
timeFrame: 6 months
measure: Days at home within the first 30 days
timeFrame: 30 days
Locations:
city: Kingswood
country: Australia
facility: Nepean Hospital
state: New South Wales
city: Liverpool
country: Australia
facility: Liverpool Hospital
state: New South Wales
city: Newcastle
country: Australia
facility: John Hunter Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Concord Repatriation Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
city: Sydney
country: Australia
facility: St George Hospital
state: New South Wales
city: Sydney
country: Australia
facility: The Sutherland Hospital
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Brisbane
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Brisbane
country: Australia
facility: The Prince Charles Hospital
state: Queensland
city: Epping
country: Australia
facility: Northern Hospital
state: Victoria
city: Melbourne
country: Australia
facility: Austin Hospital
state: Victoria
city: Melbourne
country: Australia
facility: The Victorian Heart Hospital
state: Victoria
city: Espoo
country: Finland
facility: Jorvi Hospital
city: Helsinki
country: Finland
facility: Helsinki Helsingforgs University Central Hospital
city: Kuopio
country: Finland
facility: Kuopio University Hospital
city: Oulu
country: Finland
facility: Oulu University Hospital
city: Tampere
country: Finland
facility: Tampere University Hospital
city: Lübeck
country: Germany
facility: Lübeck University Hospital
city: Luxembourg
country: Luxembourg
facility: Centre Hospitalier de Luxembourg
city: Christchurch
country: New Zealand
facility: Christchurch Hospital
city: Wellington
country: New Zealand
facility: Wellington Hospital
city: Halmstad
country: Sweden
facility: Hallands hospital
state: Halland
city: Helsingborg
country: Sweden
facility: Helsingborg Hospital
state: Skåne
city: Lund
country: Sweden
facility: Skåne University Hospital
state: Skåne
city: Malmö
country: Sweden
facility: Skåne University Hospital Malmö
state: Skåne
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
city: Solna
country: Sweden
facility: Karolinska University Hospital
city: Saint Gallen
country: Switzerland
facility: St Gallen Hospital
city: Zürich
country: Switzerland
facility: University Hospital Zürich
Study officials:
affiliation: Lund University
name: Niklas Nielsen, PhD
role: STUDY_CHAIR
References: