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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05188222
Other study ID # MP-05-2022-3112
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
Start date September 1, 2024
Est. completion date December 1, 2025

Study information

Verified date March 2024
Source Jewish General Hospital
Contact Matthew Cameron, MDCM, MPH
Phone 514-340-8222
Email matthew.cameron@mcgill.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 70
Est. completion date December 1, 2025
Est. primary completion date September 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Drug:
Maltodextrin solution
The oral preparation of 50 grams of Maltodextrin solution mixed in 400 mL of water
Placebo solution
Specifically formulated placebo to provide a similar taste and texture to Maltodextrin, without the same carbohydrate characteristics

Locations

Country Name City State
Canada Jewish General Hospital Montreal Quebec

Sponsors (1)

Lead Sponsor Collaborator
Jewish General Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Intraoperative three-dimensional left ventricular ejection fraction (3-D LVEF) LVEF as measured from a 3-D dataset After induction of anesthesia, prior to the start of surgery, and at the conclusion of surgery, just after chest closure
Secondary Right Ventricular 3-D EF Right ventricular ejection fraction as measured from a 3-D dataset After induction of anesthesia, prior to the start of surgery, and at the conclusion of surgery, just after chest closure
Secondary Left Ventricular Strain Strain values obtain by left ventricular speckle tracking After induction of anesthesia, prior to the start of surgery, and at the conclusion of surgery, just after chest closure
Secondary E/e' ratio early diastolic mitral inflow velocity to early diastolic mitral annulus velocity After induction of anesthesia, prior to the start of surgery, and at the conclusion of surgery, just after chest closure
Secondary Cardiac Index 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
Secondary Vasopressors and Inotrope Use Dose of vasopressors and inotropes used upon arrival to ICU, and the length of time that they were used First 1-7 days after surgery
Secondary Time to extubation Time from ICU arrival to extubation First 1-48 hours after surgery
Secondary Hyperglycemia Incidence of glucose levels greater than 10mmol/L First 1-48 hours after surgery
Secondary Insulin Requirements Dose of insulin required after surgery First 1-48 hours after surgery
Secondary Length of ICU stay Time from surgery to ICU discharge First 1-7 days after surgery
Secondary Hospital Length of Stay Time from surgery to discharge from the hospital 1-4 weeks after surgery
Secondary Postoperative complications as death, need for intra aortic balloon pump, dialysis, stroke, positive bacterial culture from the wound or blood 1-4 weeks after surgery
Secondary Quality of Recovery Quality of Recovery after surgery as measured by the QoR-15 questionnaire At 48 hours after surgery
Secondary Hyperinsulinemic-normoglycemic clamp (HNC) details Total dose of insulin and glucose needed, and the peak insulin dose required During the surgery
Secondary Myocardial glycogen content Measurements of myocardial mitochondrial function From biopsies optained intraoperatively, during cardiopulmonary bypass
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