Ulinastatin Improves Post-Cardiac Surgery Cognitive Dysfunction by Inhibiting Glycocalyx Degradation: An Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 7,065
- 试验地点
- 1
- 主要终点
- POCD - Postoperative Cognitive Dysfunction
研究概览
简要总结
The study comprised two primary components: a retrospective analysis of clinical big data and a conventional prospective cohort study involving patients undergoing cardiac surgery. The objectives were: 1. To assess the preventive effect of ursodeoxycholic acid on post-cardiac surgery cognitive dysfunction over an eight-year period. 2. To analyze preoperative and postoperative 24-hour plasma samples from prior studies to quantify the levels of glycocalyx and its associated regulatory factors. 3. To evaluate the clinical association between the measured parameters and patient outcomes.
详细描述
- Baseline Period Visit 1 (within 24 hours before surgery)
Sign informed consent Check inclusion/exclusion criteria Demographic data (sex, age, occupation, etc.) Past medical history (stroke, hypertension, diabetes, dyslipidemia, coronary heart disease, diabetes, etc.) and medication history in the past 3 months Vital signs (temperature, pulse, respiration, blood pressure) Preoperative ECG Preoperative echocardiography Laboratory tests (blood routine, blood glucose, blood lipids, liver and kidney function, myocardial enzymes, blood electrolytes, coagulation function) Concomitant therapy Adverse events 2. Intraoperative cardiopulmonary bypass
Record vital signs and various physiological indicators in the operating room. Routinely perform central venous puncture to establish venous access and monitor central venous pressure, and radial artery puncture to monitor invasive arterial pressure.
After general anesthesia and endotracheal intubation, routine blood chemistry and arterial blood gas analysis were performed.
After collecting the above blood samples for testing, the remaining blood was centrifuged, and the plasma was frozen at -80°C for subsequent testing (levels of CRP, IL-6, IL-10, TNF-α, TK/B1R/MMP3, Hyaluronic acid, etc.).
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntary participation in the study;
- •Age ≥ 18 years and ≤ 80 years;
- •Patients undergoing heart surgery: (coronary artery bypass grafting, heart valve replacement surgery, Morrow procedure, aortic dissection surgery).
排除标准
- •Patients experiencing adverse events during the surgery;
- •Recipients of solid organ or bone marrow transplants;
- •Patients with autoimmune diseases, tumors, or who have received high-dose steroids or immunosuppressive therapy within the past 2 months;
- •Deemed unsuitable for participation in this study by the researchers.
结局指标
主要结局
POCD - Postoperative Cognitive Dysfunction
时间窗: 24 hours
Mini-Mental State Examination（MMSE）
POD-postoperative delirium
时间窗: 7 days
Confusion Assessment Method for the ICU (CAM-ICU)
次要结局
- Survival time(28 days)
研究者
Qin Zhang
Professor
Tongji Hospital