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临床试验/NCT06051162
NCT06051162已完成不适用

Effect of Use of Hypotension Prediction System in Prevention of Postoperative Acute Kidney Injury in Robotic-assisted Urologic Surgery

Ewha Womans University Mokdong Hospital3 个研究点 分布在 2 个国家目标入组 124 人开始时间: 2023年11月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
124
试验地点
3
主要终点
Acute kidney injury

研究概览

简要总结

It is a single-center randomized controlled trial that aims to figure out the effect of the hypotension prediction index (HPI) on the prevention of acute kidney injury (AKI) after robot-assisted urological surgery. The primary hypothesis is that HPI software guidance prevents postoperative AKI by reducing the duration and severity of intraoperative hypotension (IOH).

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
Single (Participant)

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing robot-assisted urological surgery

排除标准

  • Unable to voluntarily give consent
  • Unable to use both radial arteries due to such reasons: prior surgery on the radial artery, breast cancer history with axillary LN dissection, AV fistula for renal replacement therapy, or abnormal Allen's test.

研究组 & 干预措施

Control

No Intervention

Managing intraoperative hemodynamic condition with standard anesthesia care (blinding the HPI monitor screen)

HPI

Experimental

Managing intraoperative hemodynamic condition under the HPI guidance

干预措施: BP management with HPI guidance (Device)

结局指标

主要结局

Acute kidney injury

时间窗: Seven day after the operation

Occurrence of acute kidney injury after robotic urological surgery

次要结局

  • Biomarkers(Baseline, immediate postop)
  • Hypotension prediction index(From applying HPI (hypotension prediction index) monitor to the arterial line to the end of the anesthesia)
  • Depth and duration of hypotension(From applying HPI (hypotension prediction index) monitor to the arterial line to the end of the anesthesia)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sooyoung Cho

Assistant Professor

Ewha Womans University Mokdong Hospital

研究点 (3)

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