Preoperative Maltodextrin's Effect on Cardiac Function in Cardiac Surgery

Jewish General Hospital

Status and phase: Not yet enrolling; Phase 4

Conditions: Quality of Recovery; Right Ventricular Dysfunction; Left Ventricular Dysfunction

Treatments: Drug: Placebo solution; Drug: Maltodextrin solution

Study type: Interventional

Funder types: Other

Identifiers

NCT05188222

MP-05-2022-3112

Details and patient eligibility

About

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.

Full 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

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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70 participants in 2 patient groups, including a placebo group

Intervention Group

Experimental group

Description:

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.

Treatment:

Drug: Maltodextrin solution

Placebo Group

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo solution