Preoperative Maltodextrin's Effect on Cardiac Function in Cardiac Surgery
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorJewish General Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Dysphagia, gastroparesis
Cannot tolerate oral intake
Celiac disease
Type 1 diabetes
Trial design
Design model
Parallel
Treatments tested in this trial
Maltodextrin solution
DrugThe oral preparation of 50 grams of Maltodextrin solution mixed in 400 mL of water
Placebo solution
DrugSpecifically formulated placebo to provide a similar taste and texture to Maltodextrin, without the same carbohydrate characteristics
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Intervention GroupExperimental treatment 1 intervention
Group B: Placebo GroupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Intraoperative three-dimensional left ventricular ejection fraction (3-D LVEF)
LVEF as measured from a 3-D dataset
Time frame
After induction of anesthesia, prior to the start of surgery, and at the conclusion of surgery, just after chest closureSecondary outcomes
1
Right Ventricular 3-D EF
Right ventricular ejection fraction as measured from a 3-D dataset
Time frame
After induction of anesthesia, prior to the start of surgery, and at the conclusion of surgery, just after chest closure2
Left Ventricular Strain
Strain values obtain by left ventricular speckle tracking
Time frame
After induction of anesthesia, prior to the start of surgery, and at the conclusion of surgery, just after chest closure3
E/e' ratio
early diastolic mitral inflow velocity to early diastolic mitral annulus velocity
Time frame
After induction of anesthesia, prior to the start of surgery, and at the conclusion of surgery, just after chest closure4
Cardiac Index
Cardiac index, defined as cardiac output / body surface area, as measured by pulmonary artery catheter
Time frame
After induction of anesthesia, prior to the start of surgery, and at the conclusion of surgery, just after chest closureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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