Cardiopulmonary Bypass, Cardiovascular Disease
Conditions
Keywords
Gut microbiota
Brief summary
Cardiovascular diseases (CVDs) continue to be the primary cause of illness and death globally, emphasizing the pressing requirement for efficient prevention methods. Recent studies indicate that the gut microbiome plays a vital role in maintaining cardiovascular health, affecting the pathophysiological mechanisms related to CVDs. The potential therapeutic strategies for primary care practitioners included the modulation of the gut microbiome through dietary changes, prebiotics, and probiotics. The aim of this study was to investage the effect of gut microbiome modulation on clinical outcomes after cardiac surgery.
Interventions
Intestinal Microbiota Transplant (IMT) Capsules were administered 7 days preoperatively and 14 days postoperatively.
Sponsors
Shanghai East Hospital of Tongji University
West China Hospital
The First Affiliated Hospital of Guangzhou Medical University
Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Due to the nature of this research, we could not keep the participants blind to group assignment, but the study staff and statistical analyses were all blind to patient allocation during datacollection.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Adult men and women; * Cardiovascular surgery; * Agree to participate in the study and sign the informed consent form.
Exclusion criteria
* Pregnant women; * Patients with preexisting psychotic disorders; * Decline to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Acute Gastrointestinal Injury | 14 days after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ΔSOFA | 7 days after surgery | the difference between the mean total postoperative SOFA score and baseline score within 24 hours of surgery during the index admission |
| 30-day mortality rate | 30 days after surgery | defined as mortality within 30 days postoperatively in the hospital or anywhere after discharge; |
Countries
China
Outcome results
None listed