Left Ventricular Dysfunction Clinical Trial
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
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.
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 |
Country | Name | City | State |
---|---|---|---|
Canada | Jewish General Hospital | Montreal | Quebec |
Lead Sponsor | Collaborator |
---|---|
Jewish General Hospital |
Canada,
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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