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临床试验/NCT02803372
NCT02803372已完成不适用

Impact of Circulatory Management Based on LiDCOrapid Hemodynamic Monitoring on the Incidence of Acute Kidney Injury in Patients Undergoing Partial Nephrectomy: A Randomized Controlled Trial

Peking University First Hospital1 个研究点 分布在 1 个国家目标入组 144 人开始时间: 2016年5月最近更新:
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
144
试验地点
1
主要终点
Incidence of acute kidney injury after surgery

研究概览

简要总结

The purpose of this study is to investigate whether circulatory management based on LiDCOrapid hemodynamic monitoring can reduce the incidence of acute kidney injury in patients undergoing partial nephrectomy when compared with routine circulatory management based on blood pressure and urine output monitoring

详细描述

Previous studies found that the incidence of acute kidney injury afer partial nephrectomy is higher than 30%. In addition to nephron loss induced by renal parenchyma resection, ischemia/reperfusion injury produced by clamping/unclamping of renal arteries is also an important reason. However, studies investigating the effect of circulatory management on the incidence of acute kidney injury after partial nephrectomy are limited.

It has been shown that perioperative hemodynamic optimization protected renal function in surgical patients. And in patients undergoing renal transplantation, adequate hydration and optimal perfusion enhances early graft function. The investigators hypothesize that hydration and circulatory management to guarantee optimal renal perfusion may decrease the occurrence of acute kidney injury after partial nephrectomy. The purpose of this study is to investigate whether circulatory management based on LiDCOrapid hemodynamic monitoring can reduce the incidence of acute kidney injury in patients undergoing partial nephrectomy when compared with routine circulatory management based on blood pressure and urine output monitoring.

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

  • Age > 18 years;
  • Planning to undergo partial nephrectomy;

排除标准

  • Patients with renal function damage (chronic kidney disease stage 3-5) before surgery;
  • Patients with arrhythmia or aortic valve diseases (moderate or higher degree stenosis/regurgitation);
  • Patients who has participated in other trials.

研究组 & 干预措施

Intervention group

Experimental

In addition to routine monitoring, invasive LiDCOrapid is used to monitor mean arterial pressure (MAP), stroke volume variation (SVV) and cardiac index (CI). Intraoperative goal-directed circulatory management is performed, i.e., to maintain MAP > 95 mmHg, SVV < 6%, and CI 3.0-4.0 L/min/m2, started from renal artery clamping and maintained until the end of surgery.

干预措施: Goal-directed circulatory management (Other)

Control group

Active Comparator

Routine monitoring is performed, which includes invasive blood pressure and urine output. Intraoperative routine circulatory management is performed, i.e., to maintain blood pressure within 20% from baseline level and urine output > 0.5 ml/kg/h.

干预措施: Routine circulatory management (Other)

结局指标

主要结局

Incidence of acute kidney injury after surgery

时间窗: During the first 3 days after surgery

Acute kidney injury is diagnosed according to KDIGO (Kidney Disease: Improving Global Outcomes) criteria

次要结局

  • Serum creatinine concentration(At 3 and 6 months after surgery)
  • Length of stay in hospital after surgery(From end of surgery to 30 days after surgery)
  • Incidence of postoperative complications(From end of surgery to 30 days after surgery)

研究者

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

Dong-Xin Wang

Professor

Peking University First Hospital

研究点 (1)

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