Preoperative Maltodextrin's Effect on Cardiac Function in Cardiac Surgery

Phase 4

Not yet recruiting

• Conditions: Left Ventricular Dysfunction; Quality of Recovery; Right Ventricular Dysfunction
• Interventions: Drug: Maltodextrin solution; Drug: Placebo solution

• Registration Number: NCT05188222
• Lead Sponsor: Jewish General Hospital

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

Study Timeline

• Study First Submitted: 2021-12-21
• Study First Submitted QC: 2022-01-10
• Study First Posted: 2022-01-12
• Status Verified: 2024-09
• Last Update Submitted: 2025-02-21
• Last Update Posted: 2025-02-24
• Study Start: 2025-12-01
• Primary Completion: 2026-12-01
• Study Completion: 2027-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 70

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	Maltodextrin solution	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.
Placebo Group	Placebo solution	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
Insulin Requirements	First 1-48 hours after surgery	Dose of insulin required after surgery
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

Trial Locations

Locations (1)

Jewish General Hospital; 🇨🇦 Montreal, Quebec, Canada