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Набира участници Не е приложимо NCT05564754

Sedation, Temperature and Pressure After Cardiac Arrest and Resuscitation

Не е приложима фаза (напр. обсервационно)
Заболявания: Cardiac Arrest With Successful Resuscitation Hypoxia, Brain

Спонсор: Region Skane

Налично на: БГ
Обобщение
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.
Описание
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.
Кой може да участва
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
Места на провеждане 14
Австралия (1)
Nepean Hospital
Kingswood , New South Wales
Белгия (1)
HUB Hôpital Erasme
Brussels
Estonia (1)
North Estonia Medical Centre, Tallinn
Tallinn
Финландия (1)
Jorvi Hospital
Espoo
Германия (1)
Charite University Hospital
Berlin
Ireland (1)
St Vincents University Hospital
Dublin
ACTIVE_NOT_RECRUITING
Италия (1)
San Martino Hospital Genova
Genova
Luxembourg (1)
Centre Hospitalier de Luxembourg
Luxembourg
New Zealand (1)
DCCM ICU
Auckland
Норвегия (1)
Soerlandet Hospital Arendal
Arendal
Elisabeth Nøst
Saudi Arabia (1)
King Abdulaziz Medical City
Riyadh
Сингапур (1)
Tan Tock Seng Hospital
Singapore
Швеция (1)
Hallands hospital
Halmstad , Halland County
Великобритания (1)
Essex Cardiothoracic Centre
Basildon
Технически детайли
Статус
Набира участници
Фаза
Не е приложимо
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
17.08.2023
Крайна дата
01.12.2026
Регистрационен номер
NCT05564754
Източник
anzctr
Запитване за медицински туризъм

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