Protective Effect of Probacine Against Negative Gut Metabolism and Organ Dysfunction After Cardiovascular Surgery (PANDA IV)
- Conditions
- Cardiovascular DiseaseCardiopulmonary Bypass
- Interventions
- Drug: Intestinal Microbiota Transplant (IMT) Capsules
- Registration Number
- NCT04444362
- Lead Sponsor
- Nanjing Medical University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 500
- Adult men and women;
- Cardiovascular surgery;
- Agree to participate in the study and sign the informed consent form.
- Pregnant women;
- Patients with preexisting psychotic disorders;
- Decline to participate in the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intestinal Microbial Transformation (IMT) Intestinal Microbiota Transplant (IMT) Capsules The Intestinal Microbial Transformation (IMT) group received Probacine, in addition to standard treatment and care, including prophylactic antibiotics , fluid therapy, and enteral nutrition supports.
- Primary Outcome Measures
Name Time Method Systemic inflammatory response syndrome 7 days after surgery
- Secondary Outcome Measures
Name Time Method 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;
Trial Locations
- Locations (5)
Beijing Anzhen Hospital
🇨🇳Beijing, Beijing, China
The First Affiliated Hospital of Guangzhou Medical University
🇨🇳Guangzhou, Guangdong, China
The First Affiliated Hospital of Nanjing Medical University
🇨🇳Nanjing, Jiangsu, China
West China Hospital of Sichuan University
🇨🇳Chengdu, Sichuan, China
Shanghai East Hospital, Tongji University
🇨🇳Shanghai, China
Beijing Anzhen Hospital🇨🇳Beijing, Beijing, China