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临床试验/NCT05139108
NCT05139108Unknown不适用

The Association Between Transesophageal Echocardiography Monitoring and the Incidence of Postoperative Acute Kidney Injury in Coronary Artery Bypass Grafting:a Prospective Observational Study

Qianfoshan Hospital1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2021年9月6日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
150
试验地点
1
主要终点
the incidence of postoperative acute kidney injury

研究概览

简要总结

TEE has a definite effect on the evaluation of cardiac structure and function in perioperative cardiac surgery. However, in CABG, previous studies on TEE mainly focused on whether to change the surgical plan rather than improve the clinical prognosis. There are few related studies on the evaluation of prognosis, and these studies have low efficacy and inconsistent conclusions. Acute kidney injury is the most common complication of CABG surgery and is independently associated with hospitalization and long-term mortality. In CABG patients, acute kidney injury, in addition to operation-related factors, is closely related to renal perfusion. These patients often exist serious coronary multivessel lesions and right heart dysfunction, which can cause the system obstacle of regurgitation of the inferior vena cava and kidney blood stasis, while the inappropriate rehydration fluid overload will affect kidney blood perfusion, which may be one of the reasons for the kidney injury. Therefore, appropriate volume status plays an important role in maintaining right heart function and renal perfusion. What indicators can the investigators use to effectively evaluate the patient's volume status and monitor the patient's right heart function?

In recent years, ultrasound has been used as an effective tool to assess patient volume status , right heart function, and to guide patient fluid management. Many studies have confirmed that the respiratory variability of inferior vena cava diameter (ΔIVC) measured by TTE has a good correlation with the volume status of patients on mechanical ventilation, which has a high diagnostic value for predicting the fluid responsiveness and guiding fluid management.However, no study has been reported using TEE measurements of ΔIVC to assess volume status and guide fluid management in patients undergoing cardiac bypass surgery. Previous studies have confirmed that TAPSE measured by TTE is independently associated with AKI in ICU patients and can predict the occurrence of AKI in such patients. However, TAPSE monitored by TEE have not been reported in this regard. Can ΔIVC and TAPSE predict the incidence of AKI and major cardiovascular and cerebrovascular adverse events in CABG patients?

Therefore, the investigators designed this observational study to further scientifically confirm the validity and guiding significance of ΔIVC and TAPSE in CABG, so as to protect and improve patients' renal function , reduce postoperative mortality and improve the clinical prognosis.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged ≥18 years;
  • Patients undergoing elective isolated coronary artery bypass surgery (with or without bypass);
  • In line with ethics, the patients volunteered to take the test and signed the informed consent for the clinical study;

排除标准

  • Patients with severe renal insufficiency before surgery;
  • Preoperative patients with moderate or more than moderate valvular lesions required surgery;
  • Diabetic patients with a history of serious diabetic complications (diabetic ketoacidosis, hyperosmolar coma, various infections, macrovascular lesions, diabetic nephropathy);
  • Patients with TEE contraindications

结局指标

主要结局

the incidence of postoperative acute kidney injury

时间窗: Within 7 days after surgery

acute kidney injury after cardiac surgery

次要结局

  • the incidence of major postoperative cardiovascular and cerebrovascular adverse events(Within 30 days after surgery)
  • the incidence of pulmonary complications(Within 30 days after surgery)
  • ICU endotracheal intubation time(Within 30 days after surgery)

研究者

发起方
Qianfoshan Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lili Cao

professor

Qianfoshan Hospital

研究点 (1)

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