Jewish General Hospital
Matthew Cameron, MDCM MPH
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.
Left Ventricular Dysfunction
Quality of Recovery
Right Ventricular Dysfunction
Maltodextrin solution
Placebo solution
PHASE4
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
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 70 participants |
| Masking : | QUADRUPLE |
| Masking Description : | Packets of the study drug will be prepared by Enhanced Medical Nutrition and look identical. The placebo has been formulated to taste the same as Maltodextrin as well |
| Primary Purpose : | PREVENTION |
| Official 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 |
| Actual Study Start Date : | 2025-12-01 |
| Estimated Primary Completion Date : | 2026-12-01 |
| Estimated Study Completion Date : | 2027-03-01 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 18 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
Jewish General Hospital
Montreal, Quebec, Canada, Hat 1 e