Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT05188222

Preoperative Maltodextrin's Effect on Cardiac Function in Cardiac Surgery

A randomized, controlled, double-blinded clinical trial evaluating the effect of the administration of a Maltodextrin solution on cardiac function in patients presenting for coronary artery bypass grafting surgery with a reduced left ventricular ejection fraction.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

About this study

This randomized, double-blinded clinical trial will test the primary hypothesis that patients receiving preoperative maltodextrin will have an improved intraoperative left ventricular ejection fraction (LVEF), as measured by three-dimensional echocardiography, compared to patients who receive a placebo drink. Seventy patients will be recruited and randomized to each group in a 1:1 ratio.

The second hypothesis is that administering preoperative Maltodextrin to cardiac surgery patients enhances the quality of recovery, as measured by the Quality of Recovery-15 score. Each patient will undergo this questionnaire 48 hours after surgery.

The third hypothesis is that Maltodextrin improves cardiac function by its effect on myocardial glycogen content. This will be evaluated in two ways. First, a separate group of 20 patients will undergo the hyperinsulinemic-normoglycemic clamp (HNC) to have a high-insulin level during surgery with these patients randomized to Maltodextrin or placebo. In addition, 20 patients from the main study will undergo myocardial biopsies to assess the glycogen content in the Maltodextrin and the placebo groups.

Pre-defined subgroups:

  • Need for vasopressors or inotropes during measures of cardiac function vs no need
  • Male versus female
  • Diabetic versus non-diabetic
  • Sarcopenic versus non-sarcopenic
  • Malnourished versus non-malnourished

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18 years of age or older
  • Presenting for coronary artery bypass grafting surgery
  • Preoperative left ventricular ejection fraction < 50%
  • First case of the day (7:30am start time)

Exclusion criteria

  • Dysphagia, gastroparesis
  • Cannot tolerate oral intake
  • Celiac disease
  • Type 1 diabetes

Treatment and study plan

Maltodextrin solution

Drug

The oral preparation of 50 grams of Maltodextrin solution mixed in 400 mL of water

Other names: Intervention group

Placebo solution

Drug

Specifically formulated placebo to provide a similar taste and texture to Maltodextrin, without the same carbohydrate characteristics

Other names: Placebo

Primary outcomes

  1. Intraoperative three-dimensional left ventricular ejection fraction (3-D LVEF)

    Time frame: After induction of anesthesia, prior to the start of surgery, and at the conclusion of surgery, just after chest closure

    LVEF as measured from a 3-D dataset

Secondary outcomes

  1. Right Ventricular 3-D EF

    Time frame: After induction of anesthesia, prior to the start of surgery, and at the conclusion of surgery, just after chest closure

    Right ventricular ejection fraction as measured from a 3-D dataset

  2. Left Ventricular Strain

    Time frame: After induction of anesthesia, prior to the start of surgery, and at the conclusion of surgery, just after chest closure

    Strain values obtain by left ventricular speckle tracking

  3. E/e' ratio

    Time frame: After induction of anesthesia, prior to the start of surgery, and at the conclusion of surgery, just after chest closure

    early diastolic mitral inflow velocity to early diastolic mitral annulus velocity

  4. Cardiac Index

    Time frame: After induction of anesthesia, prior to the start of surgery, and at the conclusion of surgery, just after chest closure

    Cardiac index, defined as cardiac output / body surface area, as measured by pulmonary artery catheter

  5. Vasopressors and Inotrope Use

    Time frame: First 1-7 days after surgery

    Dose of vasopressors and inotropes used upon arrival to ICU, and the length of time that they were used

  6. Time to extubation

    Time frame: First 1-48 hours after surgery

    Time from ICU arrival to extubation

  7. Hyperglycemia

    Time frame: First 1-48 hours after surgery

    Incidence of glucose levels greater than 10mmol/L

  8. Insulin Requirements

    Time frame: First 1-48 hours after surgery

    Dose of insulin required after surgery

  9. Length of ICU stay

    Time frame: First 1-7 days after surgery

    Time from surgery to ICU discharge

  10. Hospital Length of Stay

    Time frame: 1-4 weeks after surgery

    Time from surgery to discharge from the hospital

  11. Postoperative complications

    Time frame: 1-4 weeks after surgery

    as death, need for intra aortic balloon pump, dialysis, stroke, positive bacterial culture from the wound or blood

  12. Quality of Recovery

    Time frame: At 48 hours after surgery

    Quality of Recovery after surgery as measured by the QoR-15 questionnaire

  13. Hyperinsulinemic-normoglycemic clamp (HNC) details

    Time frame: During the surgery

    Total dose of insulin and glucose needed, and the peak insulin dose required

  14. Myocardial glycogen content

    Time frame: From biopsies optained intraoperatively, during cardiopulmonary bypass

    Measurements of myocardial mitochondrial function

Study contacts

Contact information is provided by the study sponsor or research team.

Matthew Cameron, MDCM, MPH

CONTACT

[email protected]

514-340-8222 ext. 25701

Mirana Rakotoarivony

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Jewish General Hospital

Other

Registry information

Official study title

The Effect of Preoperative Maltodextrin on Cardiac Function in Cardiac Surgery Patients with Reduced Left Ventricular Ejection Fraction: a Randomized, Controlled, Double-blind, Clinical Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jan 12, 2022
Registry last updated
Feb 24, 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.

Published trials that share one or more normalized conditions with this study.