Preoperative Maltodextrin's Effect on Cardiac Function in Cardiac Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Maltodextrin solution, Placebo solution.
- Who it may be relevant to
- Registry conditions: Left Ventricular Dysfunction, Quality of Recovery, Right Ventricular Dysfunction. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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
Interventions
- 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
Primary outcome measures
- Intraoperative three-dimensional left ventricular ejection fraction (3-D LVEF) [Time frame: After induction of anesthesia, prior to the start of surgery, and at the conclusion of surgery, just after chest closure]
Secondary outcome measures (12)
- Right Ventricular 3-D EF [Time frame: After induction of anesthesia, prior to the start of surgery, and at the conclusion of surgery, just after chest closure]
- Left Ventricular Strain [Time frame: After induction of anesthesia, prior to the start of surgery, and at the conclusion of surgery, just after chest closure]
- E/e' ratio [Time frame: After induction of anesthesia, prior to the start of surgery, and at the conclusion of surgery, just after chest closure]
- Cardiac Index [Time frame: After induction of anesthesia, prior to the start of surgery, and at the conclusion of surgery, just after chest closure]
- Vasopressors and Inotrope Use [Time frame: First 1-7 days after surgery]
- Time to extubation [Time frame: First 1-48 hours after surgery]
- Hyperglycemia [Time frame: First 1-48 hours after surgery]
- Insulin Requirements [Time frame: First 1-48 hours after surgery]
- Length of ICU stay [Time frame: First 1-7 days after surgery]
- Hospital Length of Stay [Time frame: 1-4 weeks after surgery]
- Postoperative complications [Time frame: 1-4 weeks after surgery]
- Quality of Recovery [Time frame: At 48 hours after surgery]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
Canada · 1 center
- Jewish General Hospital — Montreal
Identifiers
NCT: NCT05188222 · MP-05-2022-3112