Left Ventricular Dysfunction, Quality of Recovery, Right Ventricular Dysfunction
Conditions
Keywords
Cardiac surgery, Insulin, Maltodextrin, Enhanced Recovery After Surgery, Quality of Recovery After Surgery
Brief 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.
Detailed 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
Interventions
DRUGMaltodextrin solution
The oral preparation of 50 grams of Maltodextrin solution mixed in 400 mL of water
DRUGPlacebo solution
Specifically formulated placebo to provide a similar taste and texture to Maltodextrin, without the same carbohydrate characteristics
Sponsors
Jewish General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative three-dimensional left ventricular ejection fraction (3-D LVEF) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Left Ventricular Strain | 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 |
| E/e' ratio | 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 |
| Cardiac Index | 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 |
| Vasopressors and Inotrope Use | 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 to extubation | First 1-48 hours after surgery | Time from ICU arrival to extubation |
| Hyperglycemia | First 1-48 hours after surgery | Incidence of glucose levels greater than 10mmol/L |
| Right Ventricular 3-D EF | 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 |
| Length of ICU stay | First 1-7 days after surgery | Time from surgery to ICU discharge |
| Hospital Length of Stay | 1-4 weeks after surgery | Time from surgery to discharge from the hospital |
| Postoperative complications | 1-4 weeks after surgery | as death, need for intra aortic balloon pump, dialysis, stroke, positive bacterial culture from the wound or blood |
| Quality of Recovery | At 48 hours after surgery | Quality of Recovery after surgery as measured by the QoR-15 questionnaire |
| Hyperinsulinemic-normoglycemic clamp (HNC) details | During the surgery | Total dose of insulin and glucose needed, and the peak insulin dose required |
| Myocardial glycogen content | From biopsies optained intraoperatively, during cardiopulmonary bypass | Measurements of myocardial mitochondrial function |
| Insulin Requirements | First 1-48 hours after surgery | Dose of insulin required after surgery |
Countries
Canada
Contacts
Primary ContactMatthew Cameron, MDCM, MPH
Backup ContactMirana Rakotoarivony
Outcome results
None listed