Optimizing Pulsatility During Cardiopulmonary Bypass
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Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Endothelial Dysfunction, Acute Kidney Injury. Базовые параметры: 50 лет — 70 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
- 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
Optimizing Pulsatility During Cardiopulmonary Bypass to Reduce Acute Kidney Injury: Prospective Observational Study
Обзор
Cardiopulmonary bypass during cardiac surgery provides blood flow to the body during surgery but has adverse effects on different organs. Blood flow during cardiopulmonary bypass may be pulsatile or non-pulsatile, which may impact normal organ function after surgery. The study will collect data on the type of cardiopulmonary bypass used during surgery and organ function to determine if there is an association between the type of bypass and organ function.
Подробное описание
Cardiac surgery is a high-risk elective surgical procedure frequently requiring CPB in which a machine pumps blood while the surgeon operates on the heart. CPB contributes to surgical risk by causing endothelial dysfunction and acute kidney injury (AKI). Endothelial dysfunction and AKI happen because heart lung machines typically generate non-pulsatile blood flow, which is abnormal and results in impaired tissue oxygen delivery. Normal blood flow is pulsatile due intermittent contraction and relaxation of the heart during the cardiac cycle, which produces a mechanical signal that induces endothelial cells to produce nitric oxide. Without nitric oxide, blood flow does not penetrate as deeply into organs such as the kidneys which leads to acute kidney injury. AKI increases mortality 10-fold after cardiac surgery placing many people at risk since over 400,000 people have surgery with CPB each year in the United States. Thus, pulsatile CPB may influence endothelial function and renal blood flow after cardiac surgery. This study will observe patients undergoing cardiac surgery with CPB and compare patients who receive pulsatile or non-pulsatile CPB.
Первичные конечные точки
- Endothelial function [Срок оценки: From intensive care unit admission after surgery to hospital discharge, up to 30 days]
Вторичные конечные точки (12)
- Acute kidney injury [Срок оценки: From intensive care unit admission after surgery to intensive care unit discharge, up to 7 days]
- Renal blood flow velocity [Срок оценки: Intra-operative time point: after cardiopulmonary bypass, up to 12 hours]
- Acute kidney injury risk [Срок оценки: Measured 4 hours after the end of cardiopulmonary bypass, up to 12 hours]
- Perioperative death [Срок оценки: From intensive care unit admission after surgery to hospital discharge, up to 30 days]
- Myocardial infarction [Срок оценки: From intensive care unit admission after surgery to hospital discharge, up to 30 days]
- Stroke [Срок оценки: From intensive care unit admission after surgery to hospital discharge, up to 30 days]
- New renal failure requiring renal replacement therapy [Срок оценки: From intensive care unit admission after surgery to hospital discharge, up to 30 days]
- Re-exploration for bleeding [Срок оценки: From intensive care unit admission after surgery to hospital discharge, up to 30 days]
- Post-operative sepsis [Срок оценки: From intensive care unit admission after surgery to hospital discharge, up to 30 days]
- New onset atrial fibrillation [Срок оценки: From intensive care unit admission after surgery to hospital discharge, up to 30 days]
- Post-operative blood loss [Срок оценки: From intensive care unit admission to 24 hours after intensive care unit admission, up to 24 hours]
- Duration of mechanical ventilation [Срок оценки: From intensive care unit admission after surgery to hospital discharge, up to 30 days]
Критерии участия
Критерии включения
- Age 50 to 70
- Able to provide informed consent
- Scheduled for elective cardiac surgery with cardiopulmonary bypass
Критерии исключения
- Patients undergoing emergency procedures
- Diagnosed with sepsis
- Experiencing delirium
- Experiencing hemodynamic instability (heart rate > 100 and systolic blood pressure < 90)
- Patients with a mechanical circulatory support device
- Requiring vasoactive medications before surgery
- Patients with a reduced left ventricular ejection fraction (less than 50%)
- Patients with a contraindication to transesophageal echocardiography
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
США · 1 центр
- University of Colorado Hospital — Aurora
Идентификаторы
NCT: NCT05344573 · 20-2465 · K23HL151882