Impact of Preoperative Oral Carbohydrate Loading on Insulin Resistance in Pediatric Cardiac Surgery Patients
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: Carbohydrate, placebo solution.
- Кому может быть актуально
- Состояния в реестре: Cardiac Surgery, Insulin Resistance, Pediatric Cardiac Surgery. Базовые параметры: 2 лет — 16 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
- Индонезия
- 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 Oral Carbohydrate Loading on Insulin Resistance in Pediatric Patients Undergoing Cardiac Surgery: A Randomized Controlled Trial
Обзор
Surgical stress and preoperative fasting can induce insulin resistance, characterized by impaired cellular response to insulin and resulting hyperglycemia. In pediatric patients undergoing cardiac surgery, this metabolic stress response may negatively affect postoperative recovery. Although preoperative oral carbohydrate loading, defined as administering a carbohydrate-rich beverage before surgery rather than prolonged fasting, has demonstrated efficacy in reducing postoperative insulin resistance in adults, evidence supporting its use in pediatric cardiac surgery remains limited. This randomized controlled trial aims to determine whether preoperative oral carbohydrate loading reduces perioperative insulin resistance, as measured by the Homeostasis Model Assessment of Insulin Resistance (HOMA-IR), in pediatric patients undergoing cardiac surgery. The study will compare outcomes between children who receive an oral carbohydrate beverage prior to surgery and those who follow standard preoperative fasting protocols.
Подробное описание
This study is a prospective, single-blind, randomized controlled trial of pediatric patients who underwent elective cardiac surgery at Dr. Sardjito General Hospital, Yogyakarta, Indonesia, from April to August 2026. The study sample consisted of pediatric patients aged 2-16 years with an ASA physical status of 2 or 3 who had good tolerance for enteral fluid administration. Patients will be randomly assigned to one of two groups: 1. Intervention Group (Carbohydrate Loading): 3 mL/kg body weight of a maltodextrin-based carbohydrate drink 2 hours before anesthesia; 2. Control Group (Placebo Loading): 3 mL/kg body weight of plain water 2 hours before anesthesia. All patients will follow standard preoperative fasting guidelines. Blood samples for glucose and insulin testing will be collected immediately after induction (baseline), at 0 hours of Intensive Care Unit (ICU) admission, and at 24 hours of ICU admission. The primary outcome is the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR). Secondary outcomes include blood glucose levels, serum insulin concentration, exogenous insulin dose, and glycemic variability.
All study participants will undergo preoperative assessment, followed by a carbohydrate-loading protocol, and assessment of blood glucose levels, insulin resistance, exogenous insulin administration, and intraoperative and postoperative glycemic variability. Numerical data will be presented as means and standard deviations. Categorical data will be presented as counts and percentages. The Shapiro-Wilk normality test will be applied to all numerical data. Subject characteristics between the two groups will be compared using the Chi-square test for categorical data and the t-test (for normally distributed data) or the Mann-Whitney test (for non-normally distributed data) for numerical data. Pre- and postoperative HOMA-IR values will be compared using a paired t-test if the data are normally distributed, or a two-way ANCOVA (univariate GLM) if they are not. A p-value \< 0.05 will be considered statistically significant.
Вмешательства
- Пищевая добавка Carbohydrate
Participants receive 3 mL/kg body weight of a carbohydrate drink 2 hours before anesthesia induction. The drink is used to lower insulin resistance and improve perioperative recovery. - Другое placebo solution
Participants receive 3 mL/kg body weight of plain water 2 hours before surgery, following the same timing and fasting protocol as the experimental group.
Первичные конечные точки
- HOMA-IR (Homeostasis Model Assessment for Insulin Resistance) [Срок оценки: Baseline, 0 Hour ICU Admission, 24 hours ICU Admission]
Вторичные конечные точки (4)
- Blood Glucose Level [Срок оценки: Baseline, 0 hour ICU Admission, 24 hours ICU Admission]
- Serum Insulin Concentration [Срок оценки: Baseline, 0 hour ICU Admission, 24 hours ICU Admission]
- Exogenous Insulin Dose [Срок оценки: Baseline, 0 hour ICU Admission, 24 hours ICU Admission]
- Glycemic Variability [Срок оценки: Baseline, 0 Hour ICU Admission, 24 Hours ICU Admission]
Критерии участия
Критерии включения
- Age 2-16 years.
- ASA physical status 2 or 3
- Good tolerance of enteral feeding
Критерии исключения
- History of type 1 diabetes mellitus.
- History of thyroid insufficiency treated with thyroid medication.
- History of adrenal insufficiency treated with corticosteroids.
- History of gastroesophageal reflux disease.
- Patients receiving preoperative parenteral nutrition.
- Emergency or urgent cardiac surgery.
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
- Простое слепое
- Основная цель
- Поддерживающая терапия
Центры проведения
Индонезия · 1 центр
- RSUP Dr. Sardjito — Sleman
Идентификаторы
NCT: NCT07729280 · KE/FK/1142/EC/2026