Preoperative Maltodextrin's Effect on Cardiac Function in Cardiac Surgery

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

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.

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

Cardiac surgery, Insulin, Maltodextrin, Enhanced Recovery After Surgery, Quality of Recovery After Surgery

Patients will be assigned to the intervention or control group based on a computer-generated 1:1 stratified block randomization by procedure type in blocks of 4, stratified by sex.

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

Patients in the intervention group will receive an oral preparation of 50 grams of Maltodextrin solution mixed in 400 millilitres (mL) of water twice the night before surgery and within 2-3 hours before surgery. The entire drink is meant to be consumed within 15 minutes.

Patients in the intervention group will receive a placebo in 400 millilitres (mL) of water twice the night before surgery and within 2-3 hours before surgery. The entire drink is meant to be consumed within 15 minutes.

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

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

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

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

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

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

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

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

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