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临床试验/NCT04967105
NCT04967105已完成不适用

Intraoperative Renal Desaturation and Postoperative Acute Kidney Injury in Elderly Patients Undergoing Liver Resection: a Prospective Cohort Study

Chinese PLA General Hospital1 个研究点 分布在 1 个国家目标入组 157 人开始时间: 2020年9月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
157
试验地点
1
主要终点
Postoperative acute kidney injury

研究概览

简要总结

The aim of this study is to investigate the changes in renal regional oxygen saturation (rSO2) monitored by near-infrared spectroscopy (NIRS) and its relationship with the occurrence of postoperative AKI.

详细描述

Postoperative acute kidney injury (AKI) is a severe complication after liver resection and contributes to increased morbidity and mortality.

Advanced age reduces renal autoregulatory capacity due to physiological and functional changes, thus render the elderly to suffer postoperative AKI and probably the consequent chronic kidney disease. Thus, it is essential to identify those patients at high risk to develop postoperative AKI to optimize perioperative prevention and protection strategies.

Despite the multiple risk factors and potential mechanisms that have been identified, the diagnosis of postoperative AKI depending on serum creatinine changes have been delayed for early identification of postoperative AKI. It is of great interest to develop target strategies for close motoring of renal function.

This study is a prospective cohort study to investigate the associations between intraoperative renal desaturation measured by NIRS and postoperative AKI. The investigators intend to access the optimal threshold values of renal rSO2 for predicting postoperative AKI. Desaturation of renal rSO2 will be defined by the severity and duration of NIRS values during the surgical process. The principal clinical outcome of the study is postoperative AKI, defined as an absolute increase in serum creatinine of 0.3 mg/dL within 48 hours or a 1.5-fold increase from preoperative baseline within seven days after surgery, according to the Kidney Disease: Improving Global Outcomes (KDIGO) criterion.

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
60 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Elderly patients (defined as 60 years of age or older) scheduled for elective liver resection

排除标准

  • Emergency surgery
  • Liver transplantation
  • Preoperative hemodialysis
  • BMI > 30
  • Renal depth (distance from the capsule of the kidney to the skin surface) > 4 cm
  • Unable or failed to sign the informed consent

结局指标

主要结局

Postoperative acute kidney injury

时间窗: Postoperative 7 days

Postoperative acute kidney injury is defined according to the KDIGO criterion

次要结局

  • Death before and 30 days after discharge(30 days after discharge)
  • Length of hospital stay(Postoperative 30 days)

研究者

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

Weidong Mi

Director (Cheif expert of National key research and development program of China 2018YFC2001900)

Chinese PLA General Hospital

研究点 (1)

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