Carbohydrate Loading on Insulin Resistance in Open Heart Surgery

NCT06901947 | Completed DMC

• 1 other identifier: IndonesiaUAnes060
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Diseases

Outcome Measures

Primary Outcomes (10)

• Insulin resistance difference between two groups

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

  Within 30 minutes before and 30 minutes after operation

• Insulin resistance difference between two groups

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

  Within 30 minutes before and 30 minutes after operation

• Insulin resistance difference between two groups

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

  Within 30 minutes before and 30 minutes after operation

• Operation outcome difference between two groups

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

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

• Operation outcome difference between two groups

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

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

• Operation outcome difference between two groups

  Operation outcome consists of duration of ventilator use (days)

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

• Subjective well being difference between two groups

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

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

• Subjective well being difference between two groups

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

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

• Subjective well being difference between two groups

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

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

• Subjective well being difference between two groups

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

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

Study Arms (2)

Mineral water

NO INTERVENTION

Patient is given mineral water 2 hours before operation

Glucose Drink

EXPERIMENTAL

Patient is given glucose water 2 hours before operation

Dietary Supplement: Glucose drink

Interventions

Glucose drink DIETARY_SUPPLEMENT

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

Glucose Drink

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Rumah Sakit Cipto Mangunkusumo

Jakarta Pusat, DKI Jakarta, 1043, Indonesia

Location

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Investigator is blinding to the intervention given to the subjects
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: Single-blind randomized controlled trial

Study Record Dates

• First Submitted: July 15, 2024
• First Posted: March 30, 2025
• Study Start: January 1, 2023
• Primary Completion: October 10, 2023
• Study Completion: January 5, 2024
• Last Updated: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)