A Phase 4 interventional study of Maltodextrin solution and Placebo solution in Left Ventricular Dysfunction, Quality of Recovery and Right Ventricular Dysfunction, sponsored by Jewish General Hospital. Not yet recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-24.
Sponsored by Jewish General Hospital · Phase 4, Interventional, and Prevention
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:
260 studies on the registry are indexed under Ventricular Dysfunction, Left; 57 are open to participants now.
This study's planned enrollment of 70 is below the median of 100 across 151 interventional studies indexed under Ventricular Dysfunction, Left.
Browse Ventricular Dysfunction, Left studies →Jewish General Hospital is the lead sponsor of 97 studies on the registry; 11 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Maltodextrin solution
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.
Drug: Placebo solution
The oral preparation of 50 grams of Maltodextrin solution mixed in 400 mL of water
Also known as: Intervention group
Specifically formulated placebo to provide a similar taste and texture to Maltodextrin, without the same carbohydrate characteristics
Also known as: Placebo
Intraoperative three-dimensional left ventricular ejection fraction (3-D LVEF)
LVEF as measured from a 3-D dataset
Time frame: After induction of anesthesia, prior to the start of surgery, and at the conclusion of surgery, just after chest closure
Right Ventricular 3-D EF
Right ventricular ejection fraction as measured from a 3-D dataset
Time frame: After induction of anesthesia, prior to the start of surgery, and at the conclusion of surgery, just after chest closure
Left Ventricular Strain
Strain values obtain by left ventricular speckle tracking
Time frame: After induction of anesthesia, prior to the start of surgery, and at the conclusion of surgery, just after chest closure
E/e' ratio
early diastolic mitral inflow velocity to early diastolic mitral annulus velocity
Time frame: After induction of anesthesia, prior to the start of surgery, and at the conclusion of surgery, just after chest closure
Cardiac Index
Cardiac index, defined as cardiac output / body surface area, as measured by pulmonary artery catheter
Time frame: After induction of anesthesia, prior to the start of surgery, and at the conclusion of surgery, just after chest closure
Vasopressors and Inotrope Use
Dose of vasopressors and inotropes used upon arrival to ICU, and the length of time that they were used
Time frame: First 1-7 days after surgery
Time to extubation
Time from ICU arrival to extubation
Time frame: First 1-48 hours after surgery
Hyperglycemia
Incidence of glucose levels greater than 10mmol/L
Time frame: First 1-48 hours after surgery
Insulin Requirements
Dose of insulin required after surgery
Time frame: First 1-48 hours after surgery
Length of ICU stay
Time from surgery to ICU discharge
Time frame: First 1-7 days after surgery
Hospital Length of Stay
Time from surgery to discharge from the hospital
Time frame: 1-4 weeks after surgery
Postoperative complications
as death, need for intra aortic balloon pump, dialysis, stroke, positive bacterial culture from the wound or blood
Time frame: 1-4 weeks after surgery
Quality of Recovery
Quality of Recovery after surgery as measured by the QoR-15 questionnaire
Time frame: At 48 hours after surgery
Hyperinsulinemic-normoglycemic clamp (HNC) details
Total dose of insulin and glucose needed, and the peak insulin dose required
Time frame: During the surgery
Myocardial glycogen content
Measurements of myocardial mitochondrial function
Time frame: From biopsies optained intraoperatively, during cardiopulmonary bypass
Start is estimated for Dec 2025; primary completion for Dec 2026, 12 months later.
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Studies of the drug tested here: Maltodextrin
Ventricular Dysfunction, Left →
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