Preoperative Maltodextrin's Effect on Cardiac Function in Cardiac Surgery

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Right Ventricular Dysfunction; Left Ventricular Dysfunction; Quality of Recovery
• Intervention / Treatment: Drug: Maltodextrin solution; Drug: Placebo solution

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 Type: Interventional
• Enrollment (Estimated): 70
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Matthew Cameron, MDCM, MPH; Phone Number: 25701 514-340-8222; Email: matthew.cameron@mcgill.ca
• Study Contact Backup: Name: Mirana Rakotoarivony; Email: mirana.rakotoarivony@affiliate.mcgill.ca

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3T1E2
      • Jewish General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Jewish General Hospital
• Investigators: Principal Investigator: Matthew Cameron, MDCM, MPH, McGill University

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: December 21, 2021
• First Submitted That Met QC Criteria: January 10, 2022
• First Posted (Actual): January 12, 2022

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Insulin; Enhanced Recovery After Surgery; Cardiac surgery; Maltodextrin; Quality of Recovery After Surgery
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Ventricular Dysfunction; Ventricular Dysfunction, Right; Ventricular Dysfunction, Left; Pharmaceutical Solutions
• Other Study ID Numbers: MP-05-2022-3112

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No