Jewish General Hospital
Montreal, Quebec, H3T1E2, Canada
NCT Number: NCT05188222
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Phase 4
Montreal, Quebec, H3T1E2, Canada
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The oral preparation of 50 grams of Maltodextrin solution mixed in 400 mL of water
Other names: Intervention group
Specifically formulated placebo to provide a similar taste and texture to Maltodextrin, without the same carbohydrate characteristics
Other names: Placebo
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
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
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
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
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
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
Time frame: First 1-48 hours after surgery
Time from ICU arrival to extubation
Time frame: First 1-48 hours after surgery
Incidence of glucose levels greater than 10mmol/L
Time frame: First 1-48 hours after surgery
Dose of insulin required after surgery
Time frame: First 1-7 days after surgery
Time from surgery to ICU discharge
Time frame: 1-4 weeks after surgery
Time from surgery to discharge from the hospital
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
Time frame: At 48 hours after surgery
Quality of Recovery after surgery as measured by the QoR-15 questionnaire
Time frame: During the surgery
Total dose of insulin and glucose needed, and the peak insulin dose required
Time frame: From biopsies optained intraoperatively, during cardiopulmonary bypass
Measurements of myocardial mitochondrial function
Contact information is provided by the study sponsor or research team.
Jewish General Hospital
Other
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
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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.
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