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Effect of Nephrostomy on Relative Function of Obstructed Kidney

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03936673
Recruitment Status : Completed
First Posted : May 3, 2019
Last Update Posted : May 3, 2019
Sponsor:
Information provided by (Responsible Party):
Abdullah Demirtas, TC Erciyes University

Brief Summary:
Urinary tract obstruction is a serious health problem due to kidney damage. Relative renal function has an important role in the treatment of obstructed kidneys. Nephrectomy can be recommended when the relative renal function is 10% or less in radionuclide examinations. Recently, however, nephron sparing approaches have come to the fore. This indicated the need to evaluate the possibility of recovering the function of the kidney before nephrectomy. The aim of this study is to compare relative functions of obstructed kidneys in technetium 99m dimercaptosuccinic acid scintigraphy (DMSA) before and 2 weeks after nephrostomy tube.

Condition or disease Intervention/treatment Phase
Obstructive Uropathy Procedure: Percutaneous nephrostomy Not Applicable

Detailed Description:
Obstructive uropathy is one of the most important causes of acute renal injury and end-stage renal failure. obstruction of urine flow increases the intratubular pressure. This pressure increase causes decrease in renal blood flow and starts the inflammatory process. In the first few hours after total ureter obstruction, due to the increase in intratubular pressure glomerular filtration ceases and tubular transport is markedly decreased. Long lasting obstruction results in renal fibrosis and end stage renal damage. Basically obstructive uropathy leading to irreversible renal damage and loss of renal function is the main indication for simple nephrectomy. Serious renal parenchymal damage is defined as non-functioning kidney having relative renal function (RRF) 10% or less in the literature. But recently in some studies it was suggested that by applying the nephrostomy catheter, ability of kidney to regain function can be evaluated before nephrectomy. So, possibility of gaining function should be kept in mind. In this study effect of percutaneous nephrostomy tube on serum creatinine, blood urea nitrogen (BUN) and RRF in obstructed kidney with RRF 10% or less. Before and 2 weeks after percutaneous nephrostomy, serum creatinine, ure and RRF in DMSA was recorded and compared.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Patients diagnosed with unilateral obstructed kidney with RRF 10% or less underwent application of percutaneous nephrostomy tube on affected side.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Percutaneous Nephrostomy Application on Obstructed Kidneys With Relative Function of 10% or Less In Technetium-99m Dimercaptosuccinic Acid (DMSA) Scintigraphy
Actual Study Start Date : July 1, 2014
Actual Primary Completion Date : May 31, 2018
Actual Study Completion Date : January 1, 2019

Arm Intervention/treatment
Experimental: atrophic kidney
Patients diagnosed with unilateral obstructed kidney with RRF 10% or less underwent application of percutaneous nephrostomy tube on affected side.
Procedure: Percutaneous nephrostomy



Primary Outcome Measures :
  1. serum creatinine level 2 weeks after nephrostomy [ Time Frame: 2 weeks after nephrostomy ]
    serum creatinine level 2 weeks after nephrostomy

  2. Serum BUN level 2 weeks after nephrostomy [ Time Frame: 2 weeks after nephrostomy ]
    Serum BUN level 2 weeks after nephrostomy

  3. RRF in DMSA 2 weeks after nephrostomy [ Time Frame: 2 weeks after nephrostomy ]
    RRF in DMSA 2 weeks after nephrostomy



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Unilateral obstructed kidney with RRF 10% or less
  • Unilateral obstructed kidney with grade 2 or more hydroureteronephrosis
  • Defined etiology for unilateral obstructed kidney
  • estimated glomerular filtration rate (GFR) ≥ 30ml/min
  • Approving the nephrostomy procedure

Exclusion Criteria:

  • Unilateral obstructed kidney with RRF above 10%
  • Estimated GFR <30 ml/min
  • diagnosis of bilateral obstructed kidneys
  • not approving nephrostomy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03936673


Locations
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Turkey
Department of Urology, Ercieys University, Faculty Of Medicine,
Kayseri, Turkey, 38039
Sponsors and Collaborators
TC Erciyes University
Investigators
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Principal Investigator: Abdullah T Demirtas, Assoc Prof Erciyes University Faculty of Medicine

Publications of Results:
Other Publications:
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Responsible Party: Abdullah Demirtas, Md, Assoc Prof, TC Erciyes University
ClinicalTrials.gov Identifier: NCT03936673    
Other Study ID Numbers: 2014/349
First Posted: May 3, 2019    Key Record Dates
Last Update Posted: May 3, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Abdullah Demirtas, TC Erciyes University:
obstructive uropathy
relative renal function
DMSA
Additional relevant MeSH terms:
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Urologic Diseases