Preoperative Maltodextrin's Effect on Cardiac Function in Cardiac Surgery

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Left Ventricular Dysfunction, Quality of Recovery, Right Ventricular Dysfunction

Intervention / Treatment
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* Drug: Maltodextrin solution
* Drug: Placebo solution


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>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<br>* The oral preparation of 50 grams of Maltodextrin solution mixed in 400 mL of water<br>* Other names: Intervention group;|
| Placebo Comparator: Placebo Group<br>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<br>* Specifically formulated placebo to provide a similar taste and texture to Maltodextrin, without the same carbohydrate characteristics<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Time to extubation | Time from ICU arrival to extubation | First 1-48 hours after surgery | 
| Hyperglycemia | Incidence of glucose levels greater than 10mmol/L | First 1-48 hours after surgery | 
| Insulin Requirements | Dose of insulin required after surgery | First 1-48 hours after surgery | 
| Length of ICU stay | Time from surgery to ICU discharge | First 1-7 days after surgery | 
| Hospital Length of Stay | Time from surgery to discharge from the hospital | 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 | 1-4 weeks after surgery | 
| Quality of Recovery | Quality of Recovery after surgery as measured by the QoR-15 questionnaire | At 48 hours after surgery | 
| Hyperinsulinemic-normoglycemic clamp (HNC) details | Total dose of insulin and glucose needed, and the peak insulin dose required | During the surgery | 
| Myocardial glycogen content | Measurements of myocardial mitochondrial function | From biopsies optained intraoperatively, during cardiopulmonary bypass | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac surgery, Insulin, Maltodextrin, Enhanced Recovery After Surgery, Quality of Recovery After Surgery