NCT05188222

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

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Jewish General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Left Ventricular Dysfunction
• Quality of Recovery
• Right Ventricular Dysfunction

Interventions

Type	Name	Description
DRUG	Maltodextrin solution	The oral preparation of 50 grams of Maltodextrin solution mixed in 400 mL of water
DRUG	Placebo solution	Specifically formulated placebo to provide a similar taste and texture to Maltodextrin, without the same carbohydrate characteristics

Timeline

• Start date: 2025-12-01
• Primary completion: 2026-12-01
• Completion: 2027-03-01
• First posted: 2022-01-12
• Last updated: 2025-02-24

Locations

1 site across 1 country: Canada