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Recruiting Not applicable NCT05564754

Sedation, Temperature and Pressure After Cardiac Arrest and Resuscitation

No applicable phase (e.g. observational)
Conditions: Cardiac Arrest With Successful Resuscitation Hypoxia, Brain

Sponsor: Region Skane

trial.available_in: БГ
Overview
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.
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.
Who can participate
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 5. Trauma or hemorrhage being the presumed cause of arrest
Locations 14
Australia (1)
Nepean Hospital
Kingswood , New South Wales
Belgium (1)
HUB Hôpital Erasme
Brussels
Estonia (1)
North Estonia Medical Centre, Tallinn
Tallinn
Finland (1)
Jorvi Hospital
Espoo
Germany (1)
Charite University Hospital
Berlin
Ireland (1)
St Vincents University Hospital
Dublin
ACTIVE_NOT_RECRUITING
Italy (1)
San Martino Hospital Genova
Genova
Luxembourg (1)
Centre Hospitalier de Luxembourg
Luxembourg
New Zealand (1)
DCCM ICU
Auckland
Norway (1)
Soerlandet Hospital Arendal
Arendal
Elisabeth Nøst
Saudi Arabia (1)
King Abdulaziz Medical City
Riyadh
Singapore (1)
Tan Tock Seng Hospital
Singapore
Sweden (1)
Hallands hospital
Halmstad , Halland County
United Kingdom (1)
Essex Cardiothoracic Centre
Basildon
Technical details
Status
Recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
17.08.2023
Completion date
01.12.2026
Registry ID
NCT05564754
Source
anzctr
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