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临床试验/NCT05682716
NCT05682716已完成不适用

Application of Intraoperative Transesophageal Echocardiography Imaging of Vein and Controlled Low Central Venous Pressure in Early Prediction and Intervention of Acute Renal Injury Associated With Cardiac Surgery

Nanjing First Hospital, Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 137 人开始时间: 2022年7月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
137
试验地点
1
主要终点
Level of Serum creatinine

研究概览

简要总结

The goal of this clinical trial is to learn about in postoperative acute kidney injury in cardiac surgery. The main questions it aims to answer are:

  • Intraoperative Transesophageal Ultrasound Doppler venous imaging can be used to predict the occurrence of cardiac surgery associated acute kidney injury (CSA-AKI ) in the early stage by observing the changes of renal vein, portal vein and hepatic vein blood flow patterns, calculating the renal vein stasis index and portal vein pulsatility index, and evaluating the degree of venous congestion.
  • Controlled low central venous pressure (CLCVP) technology can reduce the occurrence of CSA-AKI by reducing venous congestion and increasing renal perfusion pressure.

Participants will receive Transesophageal Ultrasound Doppler during cardiac surgery. If the participant is assigned to the intervention group, if the central venous pressure of the participant is ≥ 10mmHg 30 minutes after the end of cardiopulmonary bypass, he will receive nitroglycerin pumped to apply the controlled low central venous pressure (CLCVP) technology; If participants are assigned to the control group, no intervention measures will be taken.

The researchers will compare the intervention group with the control group to see the occurrence of AKI and AKD after cardiac surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

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 above 18 years undergoing coronary artery bypass graft or heart valve surgery under cardiopulmonary bypass.

排除标准

  • Patients with CKD history, end-stage renal disease and renal transplantation before operation
  • Used nephrotoxic drugs within two weeks before operation
  • Known Renal Artery Stenosis and Renal Malformations
  • There are contraindications for transesophageal ultrasound Doppler evaluation of esophageal space occupying lesions

研究组 & 干预措施

Intervention group

Experimental

Controlled low central venous pressure (CLCVP) technology

干预措施: Controlled low central venous pressure (CLCVP) technology (Combination Product)

Intervention group

Experimental

Controlled low central venous pressure (CLCVP) technology

干预措施: Nitroglycerin (Drug)

结局指标

主要结局

Level of Serum creatinine

时间窗: Before operation to 90 days after operation

SCR

次要结局

  • Kidney Injury Molecule-1 (KIM-1)(Before operation to 12 hours after operation)
  • Neutrophil gelatinase associated lipid transporter (NGAL)(Before operation to 2 hours after operation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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