Preoperative Maltodextrin's Effect on Cardiac Function in Cardiac Surgery

NCT05188222 | Not Yet Recruiting Phase 4

• 1 other identifier: MP-05-2022-3112
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Left Ventricular Dysfunction; Quality of Recovery; Right Ventricular Dysfunction

Keywords

Cardiac surgery; Insulin; Maltodextrin; Enhanced Recovery After Surgery; Quality of Recovery After Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• 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

• Left Ventricular Strain

  After induction of anesthesia, prior to the start of surgery, and at the conclusion of surgery, just after chest closure

• E/e' ratio

  After induction of anesthesia, prior to the start of surgery, and at the conclusion of surgery, just after chest closure

• Cardiac Index

  After induction of anesthesia, prior to the start of surgery, and at the conclusion of surgery, just after chest closure

• Vasopressors and Inotrope Use

  First 1-7 days after surgery

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Placebo Group

PLACEBO COMPARATOR

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

Interventions

Maltodextrin solution DRUG

The oral preparation of 50 grams of Maltodextrin solution mixed in 400 mL of water

Also known as: Intervention group

Intervention Group

Placebo solution DRUG

Specifically formulated placebo to provide a similar taste and texture to Maltodextrin, without the same carbohydrate characteristics

Also known as: Placebo

Placebo Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Dysphagia, gastroparesis
• Cannot tolerate oral intake
• Celiac disease
• Type 1 diabetes

Sponsors & Collaborators

• Jewish General Hospital: lead

Study Sites (1)

Jewish General Hospital

Montreal, Quebec, H3T1E2, Canada

Location

MeSH Terms

Conditions

Ventricular Dysfunction, Left; Ventricular Dysfunction, Right; Insulin Resistance

Condition Hierarchy (Ancestors)

Ventricular Dysfunction; Heart Diseases; Cardiovascular Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Matthew Cameron, MDCM, MPH

  McGill University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthew Cameron, MDCM, MPH

CONTACT

514-340-8222; matthew.cameron@mcgill.ca

Mirana Rakotoarivony

CONTACT

mirana.rakotoarivony@affiliate.mcgill.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Packets of the study drug will be prepared by Enhanced Medical Nutrition and look identical. The placebo has been formulated to taste the same as Maltodextrin as well
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: December 21, 2021
• First Posted: January 12, 2022
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: February 24, 2025

Record last verified: 2024-09

Locations

CA (1)