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临床试验/NCT04693962
NCT04693962Unknown不适用

Fibroblast Growth Factor-23 as a Marker of Acute Kidney Injury After Partial Nephrectomy

University of Chile1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2017年4月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
40
试验地点
1
主要终点
Acute Kidney Injury

研究概览

简要总结

A partial nephrectomy (PN) preserves renal parenchyma with a proper oncology outcome. PN is performed during transitory ischemia to avoid massive bleeding during tumor resection. Nevertheless, the transitory ischemia might cause an acute kidney injury(AKI). AKI diagnose is based on the increase in plasma creatinine concentration and a decrease in urine output. However, both plasma creatinine concentration and diuresis are useful for the diagnose, but not in the detection of the risk patients. Therefore, there is considerable interest to find a biomarkers of kidney injury that allow clinicians to predict the development of AKI. Hence, we propose Fibroblastic Growth Factor-23 (FGF23) as a novel early biomarker to detect patients in risk to develop postoperative AKI after a PN.

We will conduct an observational and prospective study in three different groups of patients: PN gropup, patients who underwent PN with a transient and controlled renal ischemia injury using a renal artery clamping; Hemicolectomy (HC) group, patients as non-renal ischemia surgery controls, with similar demographic characteristics, but submitted to HC; and Nephrolithotomy (NL) group, patients who underwent NL, as a control of kidney surgery with physical injury.

In each patient, a time curve of plasmatic creatinine, blood urea nitrogen (BUN), and FGF23 were measure.

Our study aims to describe the role of FGF23 as an early biomarker of AKI after PN, where patients are exposed to a controlled ischemic injury.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • American Society of Anesthesiology physical status (ASA) I or II.
  • Normal preoperative plasma creatinine level
  • Baseline estimated glomerular filtration rate (eGFR) > 60 ml/min per 1.73 m2.

排除标准

  • History of chronic kidney disease
  • Alterations in the parathormone or vitamin D axis
  • Pregnant women
  • Subjects with concomitant use of nephrotoxic drugs.

结局指标

主要结局

Acute Kidney Injury

时间窗: 72 hours

Patients that develop postoperative acute kidney injury

次要结局

未报告次要终点

研究者

发起方
University of Chile
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nicolas Valls Jimenez

MD, MSc

University of Chile

研究点 (1)

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