Gut Microbiome and Gut Barrier Function in ICU Delirium Post Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Gut microbiome
研究概览
简要总结
ICU delirium are assessed by clinical nurses twice every day. Delirious patients are matched with patients according to their disease, gender and age range(±3 years). Stool samples for gene sequencing are collected. Gut barrier function are studied with several serum biomarkers (endotoxin, etc.). Ecological analyses, regression models and mediation equation will be performed.
详细描述
ICU delirium are assessed by clinical nurses twice every day using Confusion Assessment Method for the ICU (CAM-ICU). Delirious patients are matched with patients according to their disease, gender and age range(±3 years). Stool samples for gene sequencing are collected within 24 hours after surgeries. Gut barrier function are studied with several serum biomarkers (endotoxin, etc.). Ecological analyses, regression models and mediation equation will be performed.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •to have had heart valve surgery or coronary artery bypass grafting (CABG)
- •to have no planned transfer to another ward or hospital within 24 hours after surgery
- •to have no preoperative cognitive impairment and can speak and read Chinese
- •more than 18 years old
排除标准
- •to have a hearing or visual impairment that could impact delirium assessment
- •to have a history of alcohol or drug abuse
- •to have a preoperative intestinal irritation syndrome or history of gastrointestinal disease
- •to have received antibiotics or probiotics within 28 days before admission
- •to have a life expectancy less than 24 hours
- •to have an experience of ICU hospitalization, mechanical ventilation in the past 30 days
- •to have a cardiac surgery or hypoxic brain injury in the past 3 months.
结局指标
主要结局
Gut microbiome
时间窗: within 24 hours of delirium
Rectal swabs or stool samples for bacterical DNA extraction and 16S rRNA gene sequencing will be collected. Diversity and composition of gut microbiome will be compared between delirious and non-delirious patients.
次要结局
- Gut barrier biomarkers(within 24 hours of matched samples)