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Completed

NCT Number: NCT06901947

Carbohydrate Loading on Insulin Resistance in Open Heart Surgery

This study is a single-blind randomized clinical trial involving 40 adult patients undergoing elective open-heart surgery. The sample was allocated into two groups: 20 subjects in the oral carbohydrate fluid group and 20 subjects in the water group consumed 2 hours before surgery. Insulin resistance was measured by blood glucose levels, HOMA-IR index, and insulin tolerance tests. Postoperative outcomes were assessed by ICU stay duration, ventilator use, and hospital stay duration. Patient comfort factors were measured by hunger, thirst, nausea, and comfort levels.

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Key information

Conditions

Heart Diseases Cardiovascular Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rumah Sakit Cipto Mangunkusumo

Jakarta Pusat, DKI Jakarta, 1043, Indonesia

About this study

In general, preoperative fasting is mandatory for any kind of operations. This is intended to reduce the risk of aspiration during anesthesia procedure. According to recommendation from American Society of Anesthesiologist (ASA), fasting time limit is 8 hours for high calories food, 6 hours for moderate calories food, 4 hours for breastmilk, and 2 hours for clear fluid. Until today, many studies have shown that conventional fasting causes metabolic burden. Lengthy fasting period induces body's stress response, seen in increase in catabolic reaction, elevated contra insulin hormones such as glucocorticoid and catecholamine. In addition to that, surgical stimulus heightens this metabolic reaction which leads to insulin resistance. Insulin resistance causes hyperglycemia, which have a negative impact postoperatively. Several postoperative outcomes have been linked to insulin resistance, such as longer duration of ventilator and hospital stay, as well as the likelihood of postoperative infection. Cardio thorax surgery, as many other major surgeries pose a significant risk of metabolic derangement. Hyperglycemia is known to cause oxidative stress. As the risk of postoperative increases, the mortality and morbidity also increase. In the era of enhanced recovery after surgery, carbohydrate loading is given 2 hours before operation in attempt to improve outcome. Giving 50-250 grams of carbohydrate is expected to suppress catabolic process that usually occurs due to prolonged fasting. This strategy has been implemented in non cardiac surgery, which has shown benefit postoperatively. However, until today there are still limited studies regarding the use of carbohydrate loading on open heart surgeries. The investigators intend to evaluate the benefit of this practice on insulin resistance.

This study was a single-blind randomized clinical trial. The study took place in heart center of Ciptomangunkusumo (RSCM) Hospital and Jakarta Hear Center (JHC) Hospital, for 10 months starting from January 2023 to October 2023. Forty subjects were recruited following the approved ethical clearance by Ethics Committee, Universitas Indonesia. The investigators had a consecutive sampling with inclusion criteria of adult patients aged 18-65 years old who undergo open heart elective surgery and give their consent. The exclusion criteria are those with diabetes mellitus, gastroesophageal reflux, digestive malignancy, dementia, mental disturbances, as well as ASA classification of 4 or more. The drop out criteria applied were those who passed away during operation, experienced hypoglycemia with blood glucose < 70 mg/dl, withdrew from the research, and were not able to finish the data sampling.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects age 18-65 years old undergoing elective open heart surgery
  • Subjects giving informed consent

Exclusion criteria

  • Subjects with diabetes mellitus
  • Subjects with gastroesophageal reflux
  • Subjects with digestive malignancy
  • Subjects with dementia
  • Subjects with mental health
  • Subjects with ASA 4 or more

Treatment and study plan

glucose drink

Dietary Supplement

Intervention group will receive maltodextrin glucose drinks 2 hours prior to the operation

Primary outcomes

  1. Insulin resistance difference between two groups

    Time frame: Within 30 minutes before and 30 minutes after operation

    Insulin resistance seen in the level of blood glucose (mg/dL)

  2. Insulin resistance difference between two groups

    Time frame: Within 30 minutes before and 30 minutes after operation

    Insulin resistance seen in the level HOMA-IR (unitless)

  3. Insulin resistance difference between two groups

    Time frame: Within 30 minutes before and 30 minutes after operation

    Insulin resistance seen in the level insulin sensitivity test (%/minute)

  4. Operation outcome difference between two groups

    Time frame: From completion of operation to ICU discharge or death, usually under 28 days

    Operation outcome in form of length of stay in the ICU (days)

  5. Operation outcome difference between two groups

    Time frame: From completion of operation to hospital discharge or death, usually under 28 days

    Operation outcome in form of length of stay in the hospital (days)

  6. Operation outcome difference between two groups

    Time frame: From completion of operation to cessation of ventilator use or death, usually under 28 days

    Operation outcome consists of duration of ventilator use (days)

  7. Subjective well being difference between two groups

    Time frame: Preoperatively in the preparation room, usually around 1 hour before operation

    Subjective well being in form of hunger (Yes or No)

  8. Subjective well being difference between two groups

    Time frame: Preoperatively in the preparation room, usually around 1 hour before operation

    Subjective well being in form of thrist (Yes or No)

  9. Subjective well being difference between two groups

    Time frame: Preoperatively in the preparation room, usually around 1 hour before operation

    Subjective well being in form of nausea (Yes or No)

  10. Subjective well being difference between two groups

    Time frame: Preoperatively in the preparation room, usually around 1 hour before operation

    Subjective well being in form of comfort (Yes or No)

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

The Effect of Preoperative Oral Carbohydrate Solution Administration of Insulin Resistance in Patients Undergoing Elective Open-Heart Surgery

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Mar 30, 2025
Registry last updated
Apr 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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