Preoperative Maltodextrin's Effect on Cardiac Function in Cardiac Surgery

Last updated: February 21, 2025
Sponsor: Jewish General Hospital
Overall Status: Active - Not Recruiting

Phase

4

Condition

Heart Failure

Treatment

Placebo solution

Maltodextrin solution

Clinical Study ID

NCT05188222
MP-05-2022-3112
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Dysphagia, gastroparesis

  • Cannot tolerate oral intake

  • Celiac disease

  • Type 1 diabetes

Study Design

Total Participants: 70
Treatment Group(s): 2
Primary Treatment: Placebo solution
Phase: 4
Study Start date:
December 01, 2025
Estimated Completion Date:
March 01, 2027

Study Description

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

Connect with a study center

  • Jewish General Hospital

    Montreal, Quebec H3T1E2
    Canada

    Site Not Available

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