Comparing Hypothermic Temperatures During Hemiarch Surgery
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Hypothermic circulatory arrest.
- Кому может быть актуально
- Состояния в реестре: Thoracic Aortic Disease. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США, Канада
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
A Randomized Controlled Trial of Mild vs. Moderate Hypothermia on Patient Outcomes in Aortic Hemiarch Surgery With Anterograde Cerebral Perfusion
Обзор
Hypothermic circulatory arrest is an important surgical technique, allowing complex aortic surgeries to be performed safely. Hypothermic circulatory arrest provides protection to cerebral and visceral organs, but may result in longer cardiopulmonary bypass times during surgery, increased risks of bleeding, inflammation, and neuronal injury. To manage these consequences, a trend towards warmer core body temperatures during circulatory arrest has emerged. This trial will randomize patients to either mild (32°C) or moderate (26°C) hypothermia during aortic hemiarch surgery to determine if mild hypothermia reduces the length of cardiopulmonary bypass time and other key measures of morbidity and mortality.
Вмешательства
- Процедура Hypothermic circulatory arrest
During cardiac surgery requiring circulatory arrest, the patient's body temperature is lowered significantly to reduce the cellular metabolic rate and reduce ischemic injury.
Первичные конечные точки
- Composite endpoint of neurologic and acute kidney injury [Срок оценки: Up to 90 days after surgery.]
Вторичные конечные точки (12)
- Rates of Neurologic Injury [Срок оценки: Up to 90 days after surgery.]
- Incidence of Silent Strokes [Срок оценки: Up to 90 days after surgery.]
- Incidence of Acute Kidney Injury (AKI) [Срок оценки: Up to 90 days after surgery.]
- Incidence of Delirium [Срок оценки: Up to 90 days after surgery.]
- Death [Срок оценки: Up to 90 days after surgery.]
- Evaluate differences in the duration of cardiopulmonary bypass used in patients who receive mild or moderate hypothermic circulatory arrest during aortic hemiarch surgery [Срок оценки: During the index procedure]
- Rates of Mediastinal re-exploration for bleeding [Срок оценки: Up to 90 days after surgery.]
- Incidence and quantity of perioperative blood transfusions [Срок оценки: Up to 90 days after surgery.]
- Incidence of prolonged Mechanical Ventilation [Срок оценки: Up to 90 days after surgery.]
- Perioperative Myocardial Infarction [Срок оценки: Up to 48 hours after surgery.]
- Length of Stay [Срок оценки: Up to 90 days after surgery.]
- Quality of life (SF-12) [Срок оценки: Up to 90 days after surgery.]
Критерии участия
Критерии включения
- Age ≥ 18 years
- Elective aortic hemiarch surgery
- Planned unilateral selective anterograde cardioplegia
- Anticipated lower body arrest time of < 20 minutes
- Able to provide written informed consent
Критерии исключения
- Surgery for acute aortic dissection or emergent operations
- Total arch replacement
- Inability to perform unilateral selective anterograde cerebral perfusion (uSACP)
- Patients with known/documented coagulopathy
- Patients with cold agglutinin disease or those that test positive on routine preop screening
- Pre-existing severe neurological impairment or inability to accurately assess neurocognitive function as determined by the operating surgeon
- Severe carotid disease, defined as: any patient with previously documented carotid stenosis of > 70% (via Doppler ultrasound (US), magnetic resonance angiography (MRA), or computer tomography angiography (CTA)) without neurological deficits; or carotid stenosis > 50% with neurological deficits; or previous carotid endarterectomy or stenting
- Patients in renal failure or currently being treated with renal replacement therapy (RRT) or estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73m2
- Use of an investigational drug or device at time of enrollment
- Participation in another clinical trial which interferes with performance of the study procedures or assessment of the outcomes
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Двойное слепое
- Основная цель
- Лечение
Центры проведения
Канада · 9 центров
- Kelowna General Hospital — Kelowna
- Fraser Health Authority — Surrey
- University of British Columbia — Vancouver
- Dalhousie university — Halifax
- London Health Sciences Centre — London
- University of Ottawa Heart Institute — Ottawa
- University Health Network — Toronto
- Montreal Heart Institute — Montreal
- … и ещё 1 центр
США · 3 центра
- Massachusetts General — Boston
- The Valley Hospital — Ridgewood
- Ohio State University Medical Center — Columbus
Публикации
- Jabagi H, Wells G, Boodhwani M. COMMENCE trial (Comparing hypOtherMic teMperaturEs duriNg hemiarCh surgEry): a randomized controlled trial of mild vs moderate hypothermia on patient outcomes in aortic hemiarch surgery with anterograde cerebral perfusion. Trials. 2019 Dec 9;20(1):691. doi: 10.1186/s13063-019-3713-9. PMID 31815641
Идентификаторы
NCT: NCT02860364 · 20160408