Probiotic Mixture Supplementation (PMS) Promotes the Recovery of Patients After Heart Valve Replacement by Preventing Acute Gastrointestinal Injury (AGI)
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hepatopancreatobiliary Surgery Institute of Gansu Province
- Enrollment
- 52
- Locations
- 1
- Primary Endpoint
- Intra-abdominal pressure (IAP)
Overview
Brief Summary
Acute gastrointestinal injury (AGI) is related to poor outcomes in patients after heart valve replacement. The purpose of this study is to evaluate the effect of the probiotic mixture supplementation (PMS) in patients after heart valve replacement by preventing acute gastrointestinal injury (AGI).
Detailed Description
Patients with heart valve diseases often have chronic cardiac insufficiency. Accumulating evidence supports a relationship between the complexity and diversity of the gut microbiota and heart failure. Bacterial colonization and translocation of their toxins to the bloodstream due to altered intestinal permeability are directly correlated with systemic inflammation. The activation of pro-inflammatory pathways and chronic inflammation was hypothesized as a major contributing factor in the pathogenicity and progression of heart failure (HF) Patients undergoing heart valve replacement with cardiopulmonary bypass (CPB) are always complicated with gastrointestinal tract ischemia-reperfusion injury, which usually leads to AGI. AGI is related to poor outcomes of critically ill patients through many underlying mechanisms. It can leads to infectious complications, multiple organ dysfunction syndromes (MODS), and even death. On the other hand, the supply of probiotics, the good bacteria, is beneficial, despite still having a few controversial results. Therefore, it is important to carefully assess the efficacy of probiotics in the prevention of AGI and other complications in patients undergoing heart valve replacement surgery with CPB, as well as to evaluate the safety of its use.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Moderate to severe congestive heart failure (CHF) (NYHA functional class III to IV)
- •Patients with heart valve diseases undergoing CPB cardiac surgery
- •Age \> 18 years and ≤ 70 years
Exclusion Criteria
- •Patients with severe low left ventricular function: LVEF ≤ 30%
- •Patients with infective endocarditis
- •Have received major gastrointestinal surgery (including gallbladder and appendectomy) within 5 years
- •Inflammatory bowel disease (IBD), including ulcerative colitis, Crohn's disease, or colitis
- •Acute gastroenteritis
- •Clostridium difficile or Helicobacter pylori infection
- •Chronic constipation
- •Peptic ulcer
- •Polyps in the stomach or intestines
- •Gastrointestinal neoplasms
Outcomes
Primary Outcomes
Intra-abdominal pressure (IAP)
Time Frame: 1 month
We defined it as the maximum value of intra-abdominal pressure within 7 days after surgery
The AGI score
Time Frame: 1 month
The AGI score of the patient within the 7th postoperative day was performed according to the European Society of critical care (2012) guidelines for AGI.
Characteristics of gut microbiomes
Time Frame: 1 month
Feces are collected with sterilized 2 ml tubes and frozen at -80 °C until DNA extraction, preparing for microbe analysis
Secondary Outcomes
- First defecation time(1 month)
- Interleukin-10(1 month)
- N-terminal precursor brain natriuretic peptide(NT-ProBNP)(1 month)
- Return time of bowel sounds(1 month)
- Number of bowel sounds(1 month)
- Proportion of cocci and bacilli in feces(1 month)
- Bristol Stool Form Scale score(1 month)
- Procalcitonin (PCT)(1 month)
- Interleukin-6(1 month)
- High sensitivity troponin(hs TnI)(1 month)
- Trimethylamine oxide(TMAO)(1 month)
- Intestinal fatty acid-binding protein (IFABP)(1 month)
- Left ventricular ejection fraction (LVEF)(1 month)
Investigators
Wenbo Meng
Professor of Surgery
Hepatopancreatobiliary Surgery Institute of Gansu Province