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临床试验/NCT03877133
NCT03877133已完成不适用

Association of Intraoperative Renal Regional Oxygen Saturation and Acute Kidney Injury After Living Donor Liver Transplantation

Seoul National University Hospital2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年3月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
Acute Kidney Injury

研究概览

简要总结

This study is a prospective observational study of a single cohort of the patients who will undergo a scheduled living donor liver transplantation.

The investigators attempt to evaluate the association of intraoperative renal regional oxygen saturation and acute kidney injury in patients undergoing living donor liver transplantation. Near-infrared spectroscopy sensor will be attached to the skin near bilateral kidney areas in all patients and renal regional oxygen saturation will be monitored during the operation. Renal regional oxygen saturation (rSO2) of the patients who developed acute kidney injury postoperatively will be compared with rSO2 of the patients who did not.

详细描述

Acute kidney injury is a frequent complication after liver transplantation, which is related to poor prognosis and longer hospital stay. There is no sensitive or specific marker for predicting postoperative acute kidney injury, although studies of the biomarkers have shown promising results.

Near-infrared spectroscopy is a non-invasive and real-time monitoring device for regional oxygen saturation measurement. Previous studies revealed that it could be applied to the skin near the kidney and be used to monitor renal regional oxygen saturation.

Therefore, in this study, the investigators will apply near-infrared spectroscopy around kidney area to measure real-time renal regional oxygen saturation during liver transplantation surgery and investigate the association between the intraoperative renal regional oxygen saturation and the development of post-transplant acute kidney injury.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

盲法说明

Does not need masking

入排标准

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

入选标准

  • Adult patients scheduled to undergo elective living donor liver transplantation
  • Patients who provided written informed consent

排除标准

  • Missing preoperative serum creatinine value
  • Underlying kidney disease, such as hepatorenal syndrome, chronic kidney disease
  • History of unilateral or bilateral nephrectomy
  • Patients who died within 48 hours immediately after surgery
  • Any skin problem at the attachment site of regional oxygen saturation probe

结局指标

主要结局

Acute Kidney Injury

时间窗: Within 7 days after surgery

Acute kidney injury defined by the Kidney Disease Improving Global Outcomes (KDIGO) criteria using postoperative serum creatinine

次要结局

  • Early allograft dysfunction(on the postoperative 7th day after liver transplantation)
  • Nadir oxygen delivery during the surgery(Within average 8 hours after anesthesia induction during the transplantation surgery)
  • Length of hospital stay(Within 30 days after surgery)
  • Area under the curve of oxygen delivery during the surgery(Within average 8 hours after anesthesia induction during the transplantation surgery)
  • In-hospital mortality(Within 30 days after surgery)

研究者

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

Won Ho Kim, MD

Associate Professor

Seoul National University Hospital

研究点 (2)

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