Preoperative Maltodextrin for Heart Failure

Overseen By Mirana Rakotoarivony

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Jewish General Hospital

Disqualifiers: Dysphagia, Gastroparesis, Celiac, Type 1 diabetes

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

70 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests if giving a carbohydrate drink (Maltodextrin) before heart surgery can help patients with weak hearts. The goal is to see if this drink improves heart function and recovery by giving the heart extra energy.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is maltodextrin safe for human consumption?

Research suggests that maltodextrin is generally safe for human consumption. Studies show that it does not cause harmful effects at typical doses, though high intake may lead to temporary digestive discomfort like diarrhea. It is often used as a dietary fiber and has been studied for its benefits in metabolic health. ^{1 2 3 4 5}

How does the maltodextrin treatment for heart failure differ from other treatments?

Maltodextrin is unique because it is used as a preoperative beverage that can be consumed shortly before surgery, potentially enhancing recovery. Unlike other treatments, it is a carbohydrate solution that may be combined with other ingredients like glutamine or whey protein to improve metabolism, although this can affect how quickly the stomach empties. ^{5 6 7 8 9}

Research Team

Matthew Cameron, MDCM, MPH

Principal Investigator

McGill University

Eligibility Criteria

This trial is for adults over 18 who are scheduled for coronary artery bypass grafting surgery and have a left ventricular ejection fraction below 50%. It's specifically for surgeries starting at 7:30 am. People with swallowing difficulties, slow stomach emptying, intolerance to oral intake, celiac disease, or type 1 diabetes cannot participate.

Inclusion Criteria

I am 18 years old or older.

I am scheduled for surgery to improve blood flow to my heart.

Your heart's pumping ability is less than 50% before surgery.

Exclusion Criteria

You cannot swallow or tolerate taking medicine by mouth.

I have difficulty swallowing.

I have celiac disease.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Preparation

Participants receive an oral preparation of Maltodextrin or placebo the night before and within 2-3 hours before surgery

1 day

1 visit (in-person)

Surgery and Intraoperative Assessment

Intraoperative assessment of left ventricular ejection fraction and myocardial glycogen content

1 day

1 visit (in-person)

Postoperative Recovery

Quality of Recovery assessed 48 hours after surgery, monitoring of insulin requirements, and other postoperative measures

1-7 days

Daily monitoring (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including postoperative complications and hospital length of stay

1-4 weeks

Treatment Details

Interventions

• Maltodextrin solution
• Placebo solution
• Water solution

Trial Overview The study is testing if drinking a Maltodextrin solution before heart surgery can help maintain cardiac function better than a placebo. Patients are randomly assigned to one of the two groups without knowing which one they're in (double-blinded).

Participant Groups

Group I: Intervention Group Experimental Treatment 1 Intervention

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.

Group II: Placebo Group Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

Jewish General Hospital

Lead Sponsor

Trials

144

Recruited

283,000+

References

1. Japan pubmed.ncbi.nlm.nih.gov

Assessment of the safety of hydrogenated resistant maltodextrin: reverse mutation assay, acute and 90-day subchronic repeated oral toxicity in rats, and acute no-effect level for diarrhea in humans. [2019]

2. Japan pubmed.ncbi.nlm.nih.gov

Improvement effect of resistant maltodextrin in humans with metabolic syndrome by continuous administration. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Resistant Maltodextrin and Metabolic Syndrome: A Review. [2020]

4. Germany pubmed.ncbi.nlm.nih.gov

Resistant maltodextrin or fructooligosaccharides promotes GLP-1 production in male rats fed a high-fat and high-sucrose diet, and partially reduces energy intake and adiposity. [2018]

5. Brazil pubmed.ncbi.nlm.nih.gov

Residual gastric volume evaluation with ultrasonography after ingestion of carbohydrate- or carbohydrate plus glutamine-enriched beverages: a randomized, crossover clinical trial with healthy volunteers. [2017]

6. United States pubmed.ncbi.nlm.nih.gov

Efficacy of the Oral Administration of Maltodextrin Fructose Before Major Abdominal Surgery: A Prospective, Multicenter Clinical Study. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Residual gastric volume after 3 h of the ingestion of an oral supplement containing carbohydrates alone or associated with whey protein: a randomized crossover pilot study. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Orodispersible Film (ODF) Platform Based on Maltodextrin for Therapeutical Applications. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

A randomized double-blind clinical trial of a maltodextrin-containing oral rehydration solution in acute infantile diarrhea. [2022]