CompletedNot Applicable

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

Indonesia50 participantsStarted 2024-01-01

Plain-language summary

The goal of this clinical trial is to investigate the effect of preoperative oral carbohydrate on insulin resistance in adult cardiac surgery patients with a cardiopulmonary bypass machine. Insulin resistance is when the body does not respond well to insulin, which can raise blood sugar and slow recovery. The main question this study aims to answer is: Does drinking a carbohydrate drink 2 hours before surgery lower insulin resistance compared to drinking only water after on pump cardiac surgery? Researchers will compare two groups: One group will drink 400 milliliters of a maltodextrin (carbohydrate) drink (CL group). The other group will drink 400 milliliters of water (PL group). Participants will: 1. Be randomly assigned to one of the two groups. 2. Have blood samples taken to measure insulin and glucose before and after surgery (at hour-0, and hour-24 after ICU admission). 3. Be monitored in the intensive care unit for 24 hours after surgery.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria: * Age 20 to 60 years * ASA physical status II or III * Good tolerance to enteral fluid administration Exclusion criteria: * History of diabetes mellitus * Thyroid insufficiency * Adrenal insufficiency * Gastroesophageal reflux disease * Emergency cardiac surgery Dropout criteria: * Participant withdraws consent * Cardiac surgery duration exceeds 4 hours

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

HOMA-IR (Homeostasis Model Assessment for Insulin Resistance)

Timeframe: baseline, 0 hour ICU admission, and 24 hours ICU admission

Trial details

NCT IDNCT07212153

SponsorRifdhani Fakhrudin Nur

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-05-30

View on ClinicalTrials.gov More Cardiac Surgery trials