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Protective Effect of Probacine Against Negative Gut Metabolism and Organ Dysfunction After Cardiovascular Surgery (PANDA IV)

Not Applicable
Conditions
Cardiovascular Disease
Cardiopulmonary 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
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Intestinal Microbial Transformation (IMT)Intestinal Microbiota Transplant (IMT) CapsulesThe 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
NameTimeMethod
Systemic inflammatory response syndrome7 days after surgery
Secondary Outcome Measures
NameTimeMethod
ΔSOFA7 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 rate30 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

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