Prognostic Value of Novel Biomarker on Adverse Renal Outcomes in High-Risk Cardiac Surgery Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,491
- 试验地点
- 2
- 主要终点
- AKI occurrence within 3 days
研究概览
简要总结
This project aims to detect novel biomarkers from preoperative and early postoperative serum and urine samples of patients to screen and analyze the risk factors for predicting adverse postoperative renal outcomes in high-risk patients in cardiac surgery.
详细描述
This project will prospectively collect all high-risk individuals who underwent cardiac surgery, collect medical history, laboratory data and specimen test results, and test biomarkers in blood and urine specimens. Previously identified candidate biomarkers include the tumor necrosis factor-like weak inducer of apoptosis receptor (TWEAKR), galectin-9 (Gal-9), perilipin-2 (Plin2), and CCN family member 1, among others. The occurrence of postoperative AKI will be the primary endpoint of the study. The variable factors that can be used to predict and warn the main research endpoints at an early stage were screened through methods such as logistic regression, and their non-inferiority compared with traditional markers was tested. This study will facilitate early clinical identification and early warning of AKI, early implementation of preventive measures and intervention strategies, thereby improving the prognosis of patients and improve the overall safety and success rate of cardiac surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Adult patients were included in the study if they were scheduled for elective open chest cavity cardiac surgeries, with or without the use of cardiopulmonary bypass (CPB). Inclusion criteria required that patients undergoing surgery with CPB must have at least one AKI risk factor, whereas those undergoing surgery without CPB needed to have at least two AKI risk factors.
- •The AKI risk factors were as follows:
- •age >70 years;
- •30 < estimated glomerular filtration rate (eGFR) <60 mL·min-1·1.73 m-2;
- •diabetes mellitus, proteinuria;
- •a history of congestive heart failure within the previous year;
- •a left ventricular ejection fraction of 40% or lower;
- •prior cardiac surgery;
- •combined coronary artery bypass/valve procedure;
- •urgent procedure;
- •preoperative intra-aortic balloon pump.
排除标准
- •pre-existing chronic kidney disease (preoperative estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 m2);
- •previous RRT before cardiac surgery;
- •present AKI at screening;
- •a history of kidney transplant or other kidney diseases;
- •known pregnancy;
- •multiple operation during the hospital stay;
- •being in a moribund state (with an anticipated likelihood of death within 48 hours).
结局指标
主要结局
AKI occurrence within 3 days
时间窗: 3 days
AKI was defined based on the Kidney Disease Improving Global Outcomes (KDIGO) criteria.
次要结局
- Severe AKI occurrence within 7 days(7 days)
- AKI on CKD(Perioperative)
- AKI occurrence within 48 hours(48 hours)
- AKI occurrence within 7 days(7 days)
- Major adverse kidney events(90 days)
- Receipt of renal replacement treatment(90 days)
- Mortality(90 days)
- length of stay in the ICU(Perioperative)
- Length of stay in the hospital(Perioperative)
- The number of days of use and cumulative dose of vasoactive drugs(Perioperative)
研究者
Guowei Tu
Scientific Secretary for Cardiac Intensive Care Center
Shanghai Zhongshan Hospital