Left Ventricular DysfunctionPhase 4NCT05188222
Preoperative Maltodextrin's Effect on Cardiac Function in Cardiac Surgery
A Phase 4 study testing Maltodextrin solution in people with Left Ventricular Dysfunction and Quality of Recovery, run by Jewish General Hospital at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Left Ventricular Dysfunction, Quality of Recovery, Right Ventricular Dysfunction
- What is being tested?
- Maltodextrin solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteCanada
- Study dates
- 1 Dec 2025to 1 Mar 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Dysphagia, gastroparesis
- Cannot tolerate oral intake
- Celiac disease
- Type 1 diabetes
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mirana Rakotoarivony contact
About this study
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
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.
Read the 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
- Being tested
- Maltodextrin solution, Placebo solution
- Keywords
- Cardiac surgery, Insulin, Maltodextrin, Enhanced Recovery After Surgery, Quality of Recovery After Surgery
- Medical subject headings
- Ventricular Dysfunction, Left, Ventricular Dysfunction, Right, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maltodextrin solutionDrug
Also called Intervention group
The oral preparation of 50 grams of Maltodextrin solution mixed in 400 mL of water
Placebo solutionDrug
Also called Placebo
Specifically formulated placebo to provide a similar taste and texture to Maltodextrin, without the same carbohydrate characteristics
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 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. Receives: Drug: Maltodextrin solution |
| Placebo Group | Placebo comparator | 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. Receives: Drug: Placebo solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative three-dimensional left ventricular ejection fraction (3-D LVEF)
LVEF as measured from a 3-D dataset
Measured: After induction of anesthesia, prior to the start of surgery, and at the conclusion of surgery, just after chest closure
Secondary outcomes (14)
Right Ventricular 3-D EF
Right ventricular ejection fraction as measured from a 3-D dataset
Measured: After induction of anesthesia, prior to the start of surgery, and at the conclusion of surgery, just after chest closure
Left Ventricular Strain
Strain values obtain by left ventricular speckle tracking
Measured: After induction of anesthesia, prior to the start of surgery, and at the conclusion of surgery, just after chest closure
E/e' ratio
early diastolic mitral inflow velocity to early diastolic mitral annulus velocity
Measured: After induction of anesthesia, prior to the start of surgery, and at the conclusion of surgery, just after chest closure
Cardiac Index
Cardiac index, defined as cardiac output / body surface area, as measured by pulmonary artery catheter
Measured: After induction of anesthesia, prior to the start of surgery, and at the conclusion of surgery, just after chest closure
Vasopressors and Inotrope Use
Dose of vasopressors and inotropes used upon arrival to ICU, and the length of time that they were used
Measured: First 1-7 days after surgery
Time to extubation
Time from ICU arrival to extubation
Measured: First 1-48 hours after surgery
Hyperglycemia
Incidence of glucose levels greater than 10mmol/L
Measured: First 1-48 hours after surgery
Insulin Requirements
Dose of insulin required after surgery
Measured: First 1-48 hours after surgery
Length of ICU stay
Time from surgery to ICU discharge
Measured: First 1-7 days after surgery
Hospital Length of Stay
Time from surgery to discharge from the hospital
Measured: 1-4 weeks after surgery
Postoperative complications
as death, need for intra aortic balloon pump, dialysis, stroke, positive bacterial culture from the wound or blood
Measured: 1-4 weeks after surgery
Quality of Recovery
Quality of Recovery after surgery as measured by the QoR-15 questionnaire
Measured: At 48 hours after surgery
Hyperinsulinemic-normoglycemic clamp (HNC) details
Total dose of insulin and glucose needed, and the peak insulin dose required
Measured: During the surgery
Myocardial glycogen content
Measurements of myocardial mitochondrial function
Measured: From biopsies optained intraoperatively, during cardiopulmonary bypass
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study start1 Dec 2025 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Left Ventricular DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jewish General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Cameron, MDCM MPH, Jewish General Hospital
- Investigators
- Matthew Cameron, MDCM, MPH, Principal investigator, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05188222
- Sponsor's protocol ID
- MP-05-2022-3112
- Status last verified
- Sep 2024
- First submitted
- 21 Dec 2021
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05188222
- Acronym / sponsor ID
- MP-05-2022-3112
- Keywords
- Cardiac surgery, Insulin, Maltodextrin, Enhanced Recovery After Surgery, Quality of Recovery After Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Jewish General HospitalUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 12 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Drug: Maltodextrin solutionPatients 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. |
| Placebo Group | Placebo comparator | Drug: Placebo solutionPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (4 listed)
- Dysphagia, gastroparesis
- Cannot tolerate oral intake
- Celiac disease
- Type 1 diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maltodextrin solutionAlso: Intervention groupThe oral preparation of 50 grams of Maltodextrin solution mixed in 400 mL of water | Drug | Intervention Group |
| Placebo solutionAlso: PlaceboSpecifically formulated placebo to provide a similar taste and texture to Maltodextrin, without the same carbohydrate characteristics | Drug | Placebo Group |
Primary outcome
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
LVEF as measured from a 3-D dataset
14 secondary outcomes
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
Hyperinsulinemic-normoglycemic clamp (HNC) details
Time frame: During the surgery
Myocardial glycogen content
Time frame: From biopsies optained intraoperatively, during cardiopulmonary bypass
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mirana Rakotoarivony contact
Matthew Cameron, MDCM, MPH principal investigator
McGill University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Maltodextrin solution in people with Left Ventricular Dysfunction and Quality of Recovery, run by Jewish General Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matthew Cameron, MDCM, MPH (514-340-8222 ext. 25701, matthew.cameron@mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2025.