Cardiac surgery
Conditions
Interventions
This is a randomized, controlled, triple-blind, two-arm clinical study. A total of 200 participants, adults and elderly individuals of both sexes, hospitalized for cardiac surgery, were supplemented f
Sponsors
Faculdade de Ciências da Saúde
Instituto Presbiteriano Mackenzie
Eligibility
Age
20 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients requiring revascularization; adults and elderly; of both sexes; undergoing surgical treatment for cardiovascular disease or following an acute coronary event. Eligibility will be confirmed through analysis of the participant's medical record and by questioning the participant
Exclusion criteria
Exclusion criteria: Individuals following unusual diets; those with food intolerances or allergies; and those using drugs or supplements that can directly alter the immune system, gut microbiota, and appetite, as these are confounding or effect-modifying factors in this type of intervention. Patients with morbid obesity; uncontrolled blood glucose or cholesterol levels. Probiotic intake for less than three months. Inability to comply with the study procedure. As a discontinuation criterion, participants who go for two consecutive days or more without consuming the supplement
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected that probiotic supplementation, after 50 days, will contribute to the absence of serious perioperative complications, such as perioperative myocardial infarction, stroke, or death. Additionally, length of hospital stay, occurrence of healthcare-associated infections (HAIs), resistance profile of microorganisms isolated in HAIs, and hospital survival will be assessed using sociodemographic and behavioral questionnaires, the data will be compared between the groups | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected that probiotic supplementation, after 50 days, will alter the metagenomics of the fecal microbiota. To evaluate the composition of the fecal microbiota and the metabolites present, samples of approximately 5 g of feces will be collected from the participants. For the determination of the fecal microbiota composition, total bacterial DNA will be extracted from the fecal samples using specific laboratory kits for this purpose, following the manufacturer's protocol, the data will be compared between the groups;It is expected that probiotic supplementation, after 50 days,will reduce blood concentrations of high-sensitivity C-reactive protein (hs-CRP), lipopolysaccharide, serum urea, serum creatinine, glomerular filtration rate, uric acid, sodium, potassium, magnesium, calcium, urinalysis, cardiac enzymes, malondialdehyde (MDA), trimethylamine N-oxide (TMAO) and thiobarbituric acid (TBA), complete blood count, total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides, fasting glucose, glycated hemoglobin, serum albumin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), phosphorus, serum iron, ferritin, transferrin and transferrin saturation; the data will be compared between the groups;It is expected that probiotic supplementation, after 50 days, will contribute to the improvement or maintenance of nutritional status, and weight, height, body circumferences, skinfold thickness, and adductor pollicis muscle thickness (APMT) will be evaluated. A calibrated digital scale, stadiometer, anthropometric tape measure, and adipometer will be used to perform the measurements; the data will be compared between the groups | — |
Countries
Brazil
Contacts
Public ContactMacksuelle Guedes
Instituto Presbiteriano Mackenzie
Outcome results
None listed