Probiotic Mixture Supplementation (PMS) Promotes the Recovery of Patients After Heart Valve Replacement by Preventing Acute Gastrointestinal Injury (AGI)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Intra-abdominal pressure (IAP)
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •Abdominal hernia
- •Irritable bowel syndrome
- •Acute or chronic cholecystitis, hepatitis
- •Used antibiotics and probiotics in the past 1 month
- •Patients used antidiarrheals, laxatives, or prebiotics within 1 week
- •Pregnant or pregnant during follow-up
- •Failure to give informed consent (e.g. severe cognitive impairment)
- •The patient has been enrolled in other ongoing clinical trials
结局指标
主要结局
Intra-abdominal pressure (IAP)
时间窗: 1 month
We defined it as the maximum value of intra-abdominal pressure within 7 days after surgery
The AGI score
时间窗: 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
时间窗: 1 month
Feces are collected with sterilized 2 ml tubes and frozen at -80 °C until DNA extraction, preparing for microbe analysis
次要结局
- 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)
研究者
Wenbo Meng
Professor of Surgery
Hepatopancreatobiliary Surgery Institute of Gansu Province