Preoperative Maltodextrin's Effect on Cardiac Function in Cardiac Surgery
NCT ID: NCT05188222
Last Updated: 2025-02-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
70 participants
INTERVENTIONAL
2025-12-01
2027-03-01
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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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.
Maltodextrin solution
The oral preparation of 50 grams of Maltodextrin solution mixed in 400 mL of water
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.
Placebo solution
Specifically formulated placebo to provide a similar taste and texture to Maltodextrin, without the same carbohydrate characteristics
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Presenting for coronary artery bypass grafting surgery
* Preoperative left ventricular ejection fraction \< 50%
* First case of the day (7:30am start time)
Exclusion Criteria
* Cannot tolerate oral intake
* Celiac disease
* Type 1 diabetes
18 Years
ALL
No
Sponsors
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Jewish General Hospital
OTHER
Responsible Party
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Matthew Cameron, MDCM MPH
Assistant Professor
Principal Investigators
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Matthew Cameron, MDCM, MPH
Role: PRINCIPAL_INVESTIGATOR
McGill University
Locations
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Jewish General Hospital
Montreal, Quebec, Canada
Countries
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Central Contacts
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Other Identifiers
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MP-05-2022-3112
Identifier Type: -
Identifier Source: org_study_id
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