Preoperative Maltodextrin's Effect on Cardiac Function in Cardiac 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: Maltodextrin solution, Placebo solution.
- Кому может быть актуально
- Состояния в реестре: Left Ventricular Dysfunction, Quality of Recovery, Right Ventricular Dysfunction. 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
- 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
The Effect of Preoperative Maltodextrin on Cardiac Function in Cardiac Surgery Patients with Reduced Left Ventricular Ejection Fraction: a Randomized, Controlled, Double-blind, Clinical Trial
Обзор
A randomized, controlled, double-blinded clinical trial evaluating the effect of the administration of a Maltodextrin solution on cardiac function in patients presenting for coronary artery bypass grafting surgery with a reduced left ventricular ejection fraction.
Подробное описание
This randomized, double-blinded clinical trial will test the primary hypothesis that patients receiving preoperative maltodextrin will have an improved intraoperative left ventricular ejection fraction (LVEF), as measured by three-dimensional echocardiography, compared to patients who receive a placebo drink. Seventy patients will be recruited and randomized to each group in a 1:1 ratio.
The second hypothesis is that administering preoperative Maltodextrin to cardiac surgery patients enhances the quality of recovery, as measured by the Quality of Recovery-15 score. Each patient will undergo this questionnaire 48 hours after surgery.
The third hypothesis is that Maltodextrin improves cardiac function by its effect on myocardial glycogen content. This will be evaluated in two ways. First, a separate group of 20 patients will undergo the hyperinsulinemic-normoglycemic clamp (HNC) to have a high-insulin level during surgery with these patients randomized to Maltodextrin or placebo. In addition, 20 patients from the main study will undergo myocardial biopsies to assess the glycogen content in the Maltodextrin and the placebo groups.
Pre-defined subgroups:
* Need for vasopressors or inotropes during measures of cardiac function vs no need * Male versus female * Diabetic versus non-diabetic * Sarcopenic versus non-sarcopenic * Malnourished versus non-malnourished
Вмешательства
- Препарат Maltodextrin solution
The oral preparation of 50 grams of Maltodextrin solution mixed in 400 mL of water - Препарат Placebo solution
Specifically formulated placebo to provide a similar taste and texture to Maltodextrin, without the same carbohydrate characteristics
Первичные конечные точки
- Intraoperative three-dimensional left ventricular ejection fraction (3-D LVEF) [Срок оценки: After induction of anesthesia, prior to the start of surgery, and at the conclusion of surgery, just after chest closure]
Вторичные конечные точки (12)
- Right Ventricular 3-D EF [Срок оценки: After induction of anesthesia, prior to the start of surgery, and at the conclusion of surgery, just after chest closure]
- Left Ventricular Strain [Срок оценки: After induction of anesthesia, prior to the start of surgery, and at the conclusion of surgery, just after chest closure]
- E/e' ratio [Срок оценки: After induction of anesthesia, prior to the start of surgery, and at the conclusion of surgery, just after chest closure]
- Cardiac Index [Срок оценки: After induction of anesthesia, prior to the start of surgery, and at the conclusion of surgery, just after chest closure]
- Vasopressors and Inotrope Use [Срок оценки: First 1-7 days after surgery]
- Time to extubation [Срок оценки: First 1-48 hours after surgery]
- Hyperglycemia [Срок оценки: First 1-48 hours after surgery]
- Insulin Requirements [Срок оценки: First 1-48 hours after surgery]
- Length of ICU stay [Срок оценки: First 1-7 days after surgery]
- Hospital Length of Stay [Срок оценки: 1-4 weeks after surgery]
- Postoperative complications [Срок оценки: 1-4 weeks after surgery]
- Quality of Recovery [Срок оценки: At 48 hours after surgery]
Критерии участия
Критерии включения
- 18 years of age or older
- Presenting for coronary artery bypass grafting surgery
- Preoperative left ventricular ejection fraction < 50%
- First case of the day (7:30am start time)
Критерии исключения
- Dysphagia, gastroparesis
- Cannot tolerate oral intake
- Celiac disease
- Type 1 diabetes
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
- Четверное слепое
- Основная цель
- Профилактика
Центры проведения
Канада · 1 центр
- Jewish General Hospital — Montreal
Идентификаторы
NCT: NCT05188222 · MP-05-2022-3112