An interventional study of Carbohydrate and placebo solution in Cardiac Surgery, Insulin Resistance and Pediatric Cardiac Surgery, sponsored by Rifdhani Fakhrudin Nur. Not yet recruiting at 1 site in Indonesia. Open to participants aged 2 Years to 16 Years. Per ClinicalTrials.gov, last updated 2026-07-27.
Sponsored by Rifdhani Fakhrudin Nur · Not applicable, Interventional, and Supportive care
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.
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.
Exclusion Criteria:
Participants receive 3 mL/kg body weight of a carbohydrate drink 2 hours before anesthesia induction.
Dietary Supplement: Carbohydrate
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
Other: placebo solution
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.
Also known as: preoperative carbohydrate loading drink, Oral carbohydrate drink
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.
Also known as: Clear water placebo, Plain water
HOMA-IR (Homeostasis Model Assessment for Insulin Resistance)
The Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) is calculated as fasting insulin (µU/mL) × fasting glucose (mmol/L) / 22.5. Higher values indicate greater insulin resistance.
Time frame: Baseline, 0 Hour ICU Admission, 24 hours ICU Admission
Blood Glucose Level
Blood glucose measured from central venous samples to assess changes in glucose metabolism during and after cardiac surgery.
Time frame: Baseline, 0 hour ICU Admission, 24 hours ICU Admission
Serum Insulin Concentration
Serum insulin level measured from central venous blood samples to characterize perioperative insulin changes. Higher values indicate higher circulating insulin.
Time frame: Baseline, 0 hour ICU Admission, 24 hours ICU Admission
Exogenous Insulin Dose
Total daily dose of exogenous insulin (basal and/or bolus) required to achieve glycemic control will be recorded, expressed in units per day (U/day) or units per kilogram body weight per day (U/kg/day). Change in insulin dose from baseline will be used to reflect changes in insulin requirement/sensitivity.
Time frame: Baseline, 0 hour ICU Admission, 24 hours ICU Admission
Glycemic Variability
Glycemic variability is defined as the fluctuation of blood glucose levels during the perioperative period, calculated from serial blood glucose measurements. Variability will be expressed as the standard deviation (SD) and/or coefficient of variation (%CV) of serial glucose values (numeric/continuous scale). Higher SD/CV values indicate greater glycemic fluctuation during the perioperative period.
Time frame: Baseline, 0 Hour ICU Admission, 24 Hours ICU Admission
Plan to share: Yes — De-identified individual participant data (IPD) will be made available upon reasonable request to the corresponding investigator after publication of study results.
Supporting information: Study protocol, Sap, Icf
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This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Rifdhani Fakhrudin Nur