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

Sponsor
Rifdhani Fakhrudin Nur
Study ID
NCT07729280
Status
Not Yet Recruiting

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Conditions

  • Cardiac Surgery
  • Insulin Resistance
  • Pediatric Cardiac Surgery

Eligibility Criteria

Sex
ALL
Age
2 Years - 16 Years
Healthy Volunteers
Not accepted

Interventions

  • 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
    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.

Study Details

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.

Key Dates

First listed
Jul 27, 2026
Start date
Aug 25, 2026
Status verified
Jul 2026
Primary completion
Oct 30, 2026
Completion
Nov 1, 2026

Study Design

Enrollment
44 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Carbohydrate Loading (CL)
    Participants receive 3 mL/kg body weight of a carbohydrate drink 2 hours before anesthesia induction.
  • Placebo Comparator: Placebo Loading (PL)
    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

Primary Outcome Measure

HOMA-IR (Homeostasis Model Assessment for Insulin Resistance) [ Time Frame: Baseline, 0 Hour ICU Admission, 24 hours ICU Admission ]

Central Contacts

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