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Preoperative Maltodextrin for Heart Failure

Phase 4
Waitlist Available
Led By Matthew Cameron, MDCM, MPH
Research Sponsored by Jewish General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18 years of age or older
Presenting for coronary artery bypass grafting surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up first 1-48 hours after surgery
Awards & highlights

Study Summary

This trial is testing whether a Maltodextrin solution can improve cardiac function in patients with a reduced left ventricular ejection fraction who are about to have coronary artery bypass grafting surgery. The trial is double-blinded, meaning that neither the patients nor the researchers will know which patients are receiving the Maltodextrin solution until after the trial is over.

Who is the study for?
This trial is for adults over 18 who are scheduled for coronary artery bypass grafting surgery and have a left ventricular ejection fraction below 50%. It's specifically for surgeries starting at 7:30 am. People with swallowing difficulties, slow stomach emptying, intolerance to oral intake, celiac disease, or type 1 diabetes cannot participate.Check my eligibility
What is being tested?
The study is testing if drinking a Maltodextrin solution before heart surgery can help maintain cardiac function better than a placebo. Patients are randomly assigned to one of the two groups without knowing which one they're in (double-blinded).See study design
What are the potential side effects?
Potential side effects from the Maltodextrin solution could include digestive issues due to its sugar content but specific side effects related to heart function will be closely monitored given the condition of participants.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I am scheduled for surgery to improve blood flow to my heart.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from biopsies optained intraoperatively, during cardiopulmonary bypass
This trial's timeline: 3 weeks for screening, Varies for treatment, and from biopsies optained intraoperatively, during cardiopulmonary bypass for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Intraoperative three-dimensional left ventricular ejection fraction (3-D LVEF)
Secondary outcome measures
Cardiac Index
E/e' ratio
Hospital Length of Stay
+11 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Intervention GroupExperimental Treatment1 Intervention
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.
Group II: Placebo GroupPlacebo Group1 Intervention
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.

Find a Location

Who is running the clinical trial?

Jewish General HospitalLead Sponsor
138 Previous Clinical Trials
272,324 Total Patients Enrolled
Matthew Cameron, MDCM, MPHPrincipal InvestigatorMcGill University

Media Library

Maltodextrin solution (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05188222 — Phase 4
Left Ventricular Dysfunction Research Study Groups: Intervention Group, Placebo Group
Left Ventricular Dysfunction Clinical Trial 2023: Maltodextrin solution Highlights & Side Effects. Trial Name: NCT05188222 — Phase 4
Maltodextrin solution (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05188222 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are researchers still recruiting for this experiment?

"Clinicaltrials.gov does not list this trial as currently recruiting, which is consistent with the last edit to the study's page being made on August 26th 2022. However, there are 1,344 medical research studies actively enrolling patients at present."

Answered by AI

What is the main purpose of this research endeavor?

"The primary outcome of this research is to ascertain the feasibility of patients having a preoperative drink within an appropriate timeframe. Secondary objectives are length of ICU stay, insulin sensitivity measured by glucose infusion rate after one hour of hyperinsulinemic-euglycemic clamping, and post-surgery insulin requirements."

Answered by AI

To what degree is Maltodextrin solution hazardous to patients?

"There is ample evidence of Maltodextrin solution's safety, thus it acquired a score of 3."

Answered by AI

What is the overall participation rate in this experiment?

"Sadly, this trial has concluded its search for participants. It was first posted on April 1st 2023 and the last update occurred August 26th 2022. If you are seeking alternate trials related to insulin resistance, 1341 studies are enrolling patients at present and 3 clinical trials are looking for volunteers who would take Maltodextrin solution."

Answered by AI

Could you elucidate on any additional investigations which have included Maltodextrin solution?

"Presently, there are three research projects underway for Maltodextrin solution. None of these trials have reached stage 3 yet and all the conducted tests take place in Ann Arbor, Michigan across 3 different medical centres."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Preoperative Maltodextrin's Effect on Cardiac Function in Cardiac Surgery
Matthew Cameron 2024. "Preoperative Maltodextrin's Effect on Cardiac Function in Cardiac Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05188222.
~47 spots leftby Sep 2025
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