Characterizations of Gut Microbiota and Postoperative Sleep in Patients Undergoing Heart Valve Surgery With Cardiopulmonary Bypass
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- gut microbiota
研究概览
简要总结
The investigators designed a study to assess whether there is any change in gut microbiota and postoperative sleep before and after heart valve surgery with cardiopulmonary bypass.
详细描述
The investigators designed a study to assess whether there is any change in gut microbiota and postoperative sleep before and after heart valve surgery with cardiopulmonary bypass. Firstly, this study aims to characterize the gut microbiota in patients with valve disease treated with surgery. Secondly, it aims to evaluate microbiota and its influence on postoperative sleep.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ethnic Chinese;
- •Age, 18 to 65 years old;
- •Patients undergoing heart valve surgery with cardiopulmonary bypass
排除标准
- •Preoperative Pittsburgh Sleep Quality Index global scores higher than 6
- •Cognitive difficulties
- •Partial or complete gastrectomy
- •Previous esophageal surgery
- •Previous treated by radiotherapy or surgery
- •Inability to conform to the study's requirements
- •Body mass index exceeding 30 kg/m2
- •Deprivation of a right to decide by an administrative or juridical entity
- •Ongoing participation or participation in another study <1 month ago
- •Recent (< 3 months prior) use of antibiotics, probiotics, prebiotics, symbiotics, hormonal medication, laxatives, proton pump inhibitors, insulin sensitizers or traditional Chinese medicine
结局指标
主要结局
gut microbiota
时间窗: from baseline to postoperative 72 hours
This study will characterize the gut microbiota in one group of 36 patients before and after heart valve surgery
次要结局
- serum metabolites(from baseline to postoperative 72 hours)
- postoperative sleep(on the second postoperative night from 20:00 to 6:00)
研究者
Wen-fei Tan
Professor
China Medical University, China