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临床试验/NCT04241666
NCT04241666已完成不适用

Comparison of Sonographic Examination of Renal Function with Gold-standard Examination in Individuals with Long-term Spinal Cord Injury

Swiss Paraplegic Research, Nottwil1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年1月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
renal clearance

研究概览

简要总结

Patients with long-term lower urinary tract dysfunction due to spinal cord injury presenting for a routine urodynamic control will be screened for inclusion and exclusion criteria. Suitable individuals providing written informed consent will undergo renal Doppler sonography and renal scintigraphy in addition to the routine examinations. Conclusions regarding renal function based on the clearance rate determined by scintigraphy (gold standard) will be compared with the conclusions based on Doppler sonography and Cystatin C clearance.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

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

入选标准

  • long-term spinal cord injury (≥10 years)
  • age ≥30 years
  • written informed consent

排除标准

  • dementia or severe intellectual impairment
  • serious internal illness
  • previous or current tumor disease
  • known allergy to the radioactive marker (Technetium)
  • pregnancy or breastfeeding
  • withdrawal of informed consent

结局指标

主要结局

renal clearance

时间窗: at the time of inclusion into study

renal clearance of Technetium-99m-dimercaptosuccinic acid determined by scintigraphy

次要结局

  • Cystatin C concentration(at the time of inclusion into study)
  • Cystatin C clearance(at the time of inclusion into study)
  • renal peak systolic velocity(at the time of inclusion into study)
  • renal peak enddiastolic velocity(at the time of inclusion into study)
  • renal resistive index(at the time of inclusion into study)

研究者

发起方
Swiss Paraplegic Research, Nottwil
申办方类型
Network
责任方
Sponsor

研究点 (1)

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