Preoperative Maltodextrin's Effect on Cardiac Function in Cardiac Surgery

Left Ventricular Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05188222
• Other study ID #: MP-05-2022-3112
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: September 1, 2024
• Est. completion date: December 1, 2025

Study information

• Verified date: March 2024
• Source: Jewish General Hospital
• Contact: Matthew Cameron, MDCM, MPH
• Phone: 514-340-8222
• Email: matthew.cameron[@]mcgill.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: December 1, 2025
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Canada	Jewish General Hospital	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Jewish General Hospital

Country where clinical trial is conducted

Canada, 

Outcome

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