跳至主要内容
临床试验/NCT06040736
NCT06040736已完成不适用

Point-of-care Ultrasound to Assess Hydronephrosis in Patients Presenting With Acute Kidney Injury in the Emergency Department: a Prospective Comparative Pragmatic Study

University Hospital, Montpellier1 个研究点 分布在 1 个国家目标入组 155 人开始时间: 2020年7月2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
155
试验地点
1
主要终点
Performance of pont of care ultrasound (POCUS) for the diagnosis of hydronephrosis

研究概览

简要总结

Acute kidney injury (AKI) is a common diagnosis in the emergency department (ED), and urinary tract obstruction is a contributing cause that requires rapid diagnosis and therapeutic management. This observational study aims at assessing the accuracy of point-of-care ultrasound (POCUS), performed by the emergency physician (EP) for the detection of dilatation or distension of the kidney secondary to urinary tract obstruction, in emergency department patients presenting with acute kidney injury (AKI). Participants will undergo a bedside POCUS of the urinary tract by the EP followed by central imaging evaluation by a radiologist (either ultrasound or renal computed tomography (CT) or both). Researchers will compare both diagnosis. Study hypothesis is that trained emergency physicians can rapidly and reliably diagnose renal tract obstruction at POCUS in the context of AKI.

详细描述

Acute kidney injury (AKI) is a common diagnosis in the emergency department (ED), and urinary tract obstruction is a contributing cause that requires rapid diagnosis and therapeutic management. Hydronephrosis is a dilatation or distension of the kidney secondary to urinary tract obstruction. It can be diagnosed at ultrasonography or computed tomography. Assessment of the renal tract and detection of hydronephrosis is a core component of the emergency medicine Point-of-Care Ultrasound (Pocus) curriculum. The primary objective of this study is to compare the performance of point-of-care ultrasound performed by the emergency physician to that of central radiology imaging (US or CT) by a radiologist, to diagnose hydronephrosis in patients presenting with AKI in the ED. All imaging exams will be performed as part of routine evaluation, Pocus will be carried out by a trained EP blinded from radiology imaging results.

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

  • Patient with acute kidney injury defined by changes in serum creatinine (sCr) level between the index sCr at ED admission and pre and/or post sCr controls (Kidney Disease Improving Global Outcome criteria)
  • Patient who does not oppose to the use of their data

排除标准

  • Vesical globe
  • Polycystic kidney disease
  • Known renal tumor
  • Horseshoe kidney

结局指标

主要结局

Performance of pont of care ultrasound (POCUS) for the diagnosis of hydronephrosis

时间窗: 1 day (Emergency department (ED) length of stay)

Performance of POCUS for the detection of hydronephrosis compared to radiology imaging as the gold standard (Sensitivity, Specificity, Negative Predictive Value, Positive Predicted Value)

次要结局

  • Level of agreement between ED Pocus and central radiology imaging for the diagnosis of hydronephrosis(1 day (ED length of stay))
  • Risk Factors for POCUS misdiagnosis(1 day (ED length of stay))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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