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临床试验/NCT05134077
NCT05134077Unknown不适用

Influence of Simple Renal Cysts on Renal Function: Cohort Clinical Trial.

Moscow State University of Medicine and Dentistry0 个研究点目标入组 120 人开始时间: 2022年2月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
120
主要终点
Renal function

研究概览

简要总结

This is a prospective, cohort, randomized clinical trial examining the effect of simple renal cysts on renal function.

详细描述

This study is planned to include patients from S.I. Spasokukotskiy Citi Clinical Hospital with simple renal accidentally discovered cyst.

The aim of the study is to evaluate the impact of simple renal cysts on renal function and explore the correlation between cyst's size, parenchymal atrophy, and renal function.

After receiving the results, the analysis of the data obtained is carried out.

  1. The symmetry of the function of both kidneys is analyzed
  2. The relationship between the presence of a simple kidney cyst and a decrease in its function in comparison with a healthy kidney is analyzed.
  3. The relationship between the maximum size of a kidney cyst and a decrease in its function in comparison with a healthy kidney is analyzed.
  4. The relationship between the volume of the atrophied kidney parenchyma and a decrease in its function as compared with a healthy kidney is analyzed.
  5. Correspondence of GFR indices obtained by scintigraphy and by calculation using the Schwartz formula

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adult patients with simple kidney cyst Bosniak 1-2
  • •Normal blood creatinine values

排除标准

  • •Impossibility of performing CT with intravenous contrast enhancement.
  • •Bosniak 3-4
  • •Bilateral cysts
  • •Multiple renal cysts
  • •Sinus cysts
  • •Cysts with a max size less than 2 cm.
  • •Single kidney
  • •Chronic kidney disease and conditions associated with the potential decrease of kidney function
  • •Glomerulonephritis
  • •Chronic pyelonephritis
  • •Amyloidosis
  • •Autoimmune diseases
  • •Urolithiasis
  • •Kidney and upper urinary tract surgery
  • •Anomalies of the kidneys and upper urinary tract with impaired outflow
  • •Calcification of the renal arteries
  • •Renal artery stenosis
  • •Hypertensive nephropathy
  • •Severe concomitant diseases requiring
  • •Chemotherapy
  • •Long-term (more than 10 days) antibiotic therapy in the last month
  • •Long-term (more than 7 days) use of NSAIDs in the last month
  • •Diagnostic and therapeutic manipulations accompanied by the introduction of X-ray contrast agents
  • •Secondarily shriveled or non-functioning kidney
  • •Kidney hypoplasia
  • •Accessory kidney
  • •a decrease in GFR below normal values for a kidney without a cyst (as determined by nephroscintigraphy)

研究组 & 干预措施

kidneys with simple cysts

Experimental

Patients involve from Citi Clinical Hospital with simple renal accidentally discovered cyst.

干预措施: CT scan with contrast (Procedure)

kidneys with simple cysts

Experimental

Patients involve from Citi Clinical Hospital with simple renal accidentally discovered cyst.

干预措施: Nephroscintigraphy (Radiation)

contralateral kidneys without cyst

Active Comparator

Рatients involve from Citi Clinical Hospital with simple renal accidentally discovered cyst.

干预措施: CT scan with contrast (Procedure)

contralateral kidneys without cyst

Active Comparator

Рatients involve from Citi Clinical Hospital with simple renal accidentally discovered cyst.

干预措施: Nephroscintigraphy (Radiation)

结局指标

主要结局

Renal function

时间窗: 1 month

Glomerular filtration rate (GFR, ml/min/1.73 m2) is a test used to check how well the kidneys are working. Specifically, it estimates how much blood passes through the glomeruli each minute. A GFR of 60 or higher is in the normal range. A GFR below 60 may mean kidney disease. A GFR of 15 or lower may mean kidney failure. The measurement of the glomerular filtration rate will be measured according to the results of the blood test and the results of nephroscintigraphy

次要结局

  • Ratio of cyst size and volume of atrophic renal parenchyma(1 month)

研究者

发起方
Moscow State University of Medicine and Dentistry
申办方类型
Other
责任方
Sponsor

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