跳至主要内容
临床试验/NCT03527160
NCT03527160已完成不适用

Assessment of Urinary Neutrophil Gelatinase-Associated Lipocalin to Predict Acute Kidney Injury in Children Research Multiple Nephrotoxic Medications

Children's Hospital Medical Center, Cincinnati2 个研究点 分布在 1 个国家目标入组 134 人开始时间: 2018年4月23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
134
试验地点
2
主要终点
Number of Patients With Nephrotoxic Medication Associated AKI Detected by Urinary NGAL

研究概览

简要总结

Nephrotoxic medication (NTMx) exposure is one of the most commonly cited causes of acute kidney injury (AKI) in hospitalized children, and is the primary cause of AKI in 16% of cases. Through initial work at Cincinnati Children's Medical Center, NTMx exposure was found to be potentially modifiable and the associated AKI is an avoidable adverse safety event. Currently, only serum Creatinine monitoring is available to monitor for NTMx-associated AKI. The hypotheses of this NINJA NGAL study are that (1) urine NGAL is highly sensitive to detect NTMx-associated AKI, and (2) Bedside test of urine from high risk NTMx-exposed patients are adequate and reliable compared to urine NGAL measured from the clinical platform.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Receiving 3 or more nephrotoxic medications on the same day OR
  • Receiving 3 or more days of an intravenous aminoglycoside or vancomycin

排除标准

  • Currently being treated for a urinary tract infection
  • Presence of an acute kidney injury prior to enrollment

结局指标

主要结局

Number of Patients With Nephrotoxic Medication Associated AKI Detected by Urinary NGAL

时间窗: 9 Days

AKI, defined as a 50% rise in serum Creatinine over baseline or a 0.3 mg/dL rise within 48 hours, will be first detected by a rise in Urinary NGAL

次要结局

  • Point of Care NGAL Reliability Compared to Clinical Urinary NGAL(7 Days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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