Influence of Simple Renal Cysts on Renal Function

Overview

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

Full Title of Study: “Influence of Simple Renal Cysts on Renal Function: Cohort Clinical Trial.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 8, 2022

Detailed Description

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

Interventions

  • Procedure: CT scan with contrast
    • CT scan with contrast is necessary to determine the position of renal cysts, their location, and size (determine volume of atrophic parenchyma will be calculated).
  • Radiation: Nephroscintigraphy
    • Nephroscintigraphy is necessary to determine the renal function

Arms, Groups and Cohorts

  • Experimental: kidneys with simple cysts
    • Patients involve from Citi Clinical Hospital with simple renal accidentally discovered cyst.
  • Active Comparator: contralateral kidneys without cyst
    • –†atients involve from Citi Clinical Hospital with simple renal accidentally discovered cyst.

Clinical Trial Outcome Measures

Primary Measures

  • Renal function
    • Time Frame: 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

Secondary Measures

  • Ratio of cyst size and volume of atrophic renal parenchyma
    • Time Frame: 1 month
    • Computed tomography with contrast will be used to determine the position of renal cysts, their location, size and volume of atrophic parenchyma (cm2) are calculated

Participating in This Clinical Trial

Inclusion Criteria

  • Adult patients with simple kidney cyst Bosniak 1-2 – Normal blood creatinine values Exclusion Criteria:

  • Impossibility of performing CT with intravenous contrast enhancement. – Bosniak 3-4 – CKD – 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 – Diabetes – 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)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Moscow State University of Medicine and Dentistry
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Tukhtasin Mahmudov, Principal Investigator, Moscow state university of medicine and dentistry named after A.I. Evdokimov
  • Overall Contact(s)
    • Vigen Malkhasyan, +7(909) 644-16-88, vigenmalkhasyan@gmail.com

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.