跳至主要内容
临床试验/NCT03855085
NCT03855085已完成不适用

Assessment of the Reproducibility of Kidney Transplant Sonographic Volume Measurement

University Hospital, Tours1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年7月25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
100
试验地点
1
主要终点
Intraclass coefficient of correlation of the ultrasound volume measurement

研究概览

简要总结

This study assesses the reproducibility of 3 different formulas in calculating the volume of a transplanted kidney by ultrasound in-vivo measurements.

3 series of measurements will be performed by 2 different operators during the usual ultrasound follow-up of the renal transplant.

详细描述

The 3 series of measurements

  1. Longitudinal section: maximum longitudinal length, width at the hilum, maximum width, width at the upper third, longitudinal cross-sectional area
  2. Transverse section at the hilum : thickness, width, hilar cross-sectional area
  3. Largest transverse section : thickness, width, maximum transverse cross-sectional area

Clinical and biological patient data collection:

age, gender, date of transplantation, serum creatinine and glomerular filtration rate (GFR), kidney transplant placement (right or left iliac fossa), acute illness or usual follow-up

研究设计

研究类型
Observational
观察模型
Case Only
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

  • Kidney transplant recepients with ultrasound follow-up at the University Hospital of Tours
  • Age more than 18 years old

排除标准

  • Renal deformity of extrinsic origin
  • Early post-transplant period (first 3 days post-transplant)
  • Transplanted organ out of the field of view
  • Dual kidney transplant
  • Opposition to the data collection

结局指标

主要结局

Intraclass coefficient of correlation of the ultrasound volume measurement

时间窗: 6 months

The inter-observer and intra-observer variability of the ultrasound volume measurement of the kidney graft will be assessed using the intraclass coefficient of correlation (ICC)

次要结局

  • Intraclass coefficient of correlation of the volume formula parameters.(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Kidney Transplant Volumetry | 临床试验