Clinical trial NCT05188222: Preoperative Maltodextrin's Effect on Cardiac Function in Cardiac Surgery
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Left Ventricular Dysfunction
Quality of Recovery
Right Ventricular Dysfunction
Keywords: Cardiac surgery
Insulin
Maltodextrin
Enhanced Recovery After Surgery
Quality of Recovery After Surgery
Lead sponsor: Jewish General Hospital
Sponsor class: OTHER
First posted: 2022-01-12
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

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

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

Primary outcomes:
measure: Intraoperative three-dimensional left ventricular ejection fraction (3-D LVEF)
timeFrame: After induction of anesthesia, prior to the start of surgery, and at the conclusion of surgery, just after chest closure
Secondary outcomes:
measure: Right Ventricular 3-D EF
timeFrame: After induction of anesthesia, prior to the start of surgery, and at the conclusion of surgery, just after chest closure
measure: Left Ventricular Strain
timeFrame: After induction of anesthesia, prior to the start of surgery, and at the conclusion of surgery, just after chest closure
measure: E/e' ratio
timeFrame: After induction of anesthesia, prior to the start of surgery, and at the conclusion of surgery, just after chest closure
measure: Cardiac Index
timeFrame: After induction of anesthesia, prior to the start of surgery, and at the conclusion of surgery, just after chest closure
measure: Vasopressors and Inotrope Use
timeFrame: First 1-7 days after surgery
measure: Time to extubation
timeFrame: First 1-48 hours after surgery
measure: Hyperglycemia
timeFrame: First 1-48 hours after surgery
measure: Insulin Requirements
timeFrame: First 1-48 hours after surgery
measure: Length of ICU stay
timeFrame: First 1-7 days after surgery
measure: Hospital Length of Stay
timeFrame: 1-4 weeks after surgery
measure: Postoperative complications
timeFrame: 1-4 weeks after surgery
measure: Quality of Recovery
timeFrame: At 48 hours after surgery
measure: Hyperinsulinemic-normoglycemic clamp (HNC) details
timeFrame: During the surgery
measure: Myocardial glycogen content
timeFrame: From biopsies optained intraoperatively, during cardiopulmonary bypass
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
Study officials:
affiliation: McGill University
name: Matthew Cameron, MDCM, MPH
role: PRINCIPAL_INVESTIGATOR
References: