Health Trials

Impact of Preoperative Oral Carbohydrate Loading on Insulin Resistance in Pediatric Cardiac Surgery Patients

ConditionsCardiac SurgeryInsulin ResistancePediatric Cardiac Surgery
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-16
SponsorRifdhani Fakhrudin Nur

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 2-16 years.

ASA physical status 2 or 3

Good tolerance of enteral feeding

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Carbohydrate

    Dietary supplement

    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.

  • placebo solution

    Other intervention

    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.

Treatment groups

44 Participants
are divided into 2 treatment groups
Group A: Carbohydrate Loading (CL)Experimental treatment 1 intervention
Group B: Placebo Loading (PL)Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rifdhani Fakhrudin Nur

Lead sponsor

Gadjah Mada University

Sponsor institution

Source ClinicalTrials.gov

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