Mode of Drainage Of Bilaterally Obstructed Kidneys
Primary Purpose
Obstructive Nephropathy
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
unilateral drainage of Bilaterally Obstructed Kidneys
bilateral drainage of Bilaterally Obstructed Kidneys
Sponsored by

About this trial
This is an interventional screening trial for Obstructive Nephropathy
Eligibility Criteria
Inclusion Criteria:
- Adult patients ( >18 yrs ) with bilateral obstructed kidneys
- Bilateral obstructed kidneys due to benign causes
- Bilateral obstructed kidneys due to malignant causes
- Bilateral obstructed kidneys with high serum creatinine
Exclusion Criteria:
- Age < 18 yrs
- Bilateral obstructed kidneys with normal serum creatinine
- patients with chronic kidney disease
- Vesicoureteric reflux
- Severe comorbidity preventing intervention
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Bilaterally Obstructed Kidneys by benign cause
Bilaterally Obstructed Kidneys by malignant cause
Arm Description
Outcomes
Primary Outcome Measures
when the serum creatinine comes to normal after drainage of bilaterally obstructed kidneys either on one side or 2 sides
The investigators will measure seum creatinine of patients with bilaterally obstructed kidneys and raised serum chemistry who are in urgent need for intervention . After intervention , either by PCn or ureteric stents , serum chemistry will be measured in those patient again in fixed times e.g; after 6 hrs , 1 day , 3 days , 1 week , 2 weeks . after collecting and processing the data we will come to a conclusion either bilateral drainage of patients with bilaterally obstructed kidneys due to benign cause is faster to return serum chemistry to normal than unilateral drainage. The same will be applied to patients of bilaterally obstructed kidneys due to malignant cause .
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04077008
Brief Title
Mode of Drainage Of Bilaterally Obstructed Kidneys
Official Title
Mode of Drainage Of Bilaterally Obstructed Kidneys Due to Benign or Malignant Causes: A Prospective Comparative Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 25, 2019 (Anticipated)
Primary Completion Date
December 30, 2021 (Anticipated)
Study Completion Date
April 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Bilaterally obstructed kidneys could be caused by benign or malignant causes it could lead to renal failure which can be avoided by urgent drainage either by PCN or DJ , The aim is to determine whether unilateral or bilateral drainage make a difference in improvement of renal function of bilaterally obstructed kidneys and whether that improvement relays on the cause of the obstruction.
The investigators will do that by doing a prospective comparative study on patients presented to our department by bilaterally obstructed kidneys , by either benign or malignant causes , with high serum chemistry. Intervention to this cases will be done by inserting JJ or PCN either unilateral or bilateral depending upon lab workups , our staff decision and patients fittness and agreement .
Detailed Description
Kidney obstruction means obstruction of urinary flow with back pressure on the kidney, which may be unilateral or bilateral, may have many causes either benign e.g; urolithiasis, retroperitoneal fibrosis, renal papillary necrosis or malignant e.g; urinary tract tumors as bladder cancer and prostate cancer, or Extrinsic tumor as cervical cancer(5) , lymphoma or other pelvic tumors When kidney obstruction occurs bilaterally this raises serum chemistry and may lead to post-renal AKI which represents about (1-10%) of all causes of AKI. Post-renal AKI is an emergency case that requires an urgent and minimally invasive procedure to drain the urine either by PCN or ureteric stents.
There has been always a debate about which one is better to drain the obstructed kidneys percutaneous nephrostomy or ureteric stents and which is better in improvement of renal function and with less effect on life style . Also the mode of drainage of the obstructed kidneys, bilateral or unilateral, also has been a point of debate. Unless bilateral renal obstruction is due to benign or treatable malignant cause, unilateral nephrostomy is always the rule according to some authors . some authors, reported better improvement in renal function with bilateral PCN with pelvic tumors The investigators will do prospective comparative study for studying mode and laterality of drainage in benign and malignant causes in bilaterally obstructed kidneys .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Nephropathy
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bilaterally Obstructed Kidneys by benign cause
Arm Type
Other
Arm Title
Bilaterally Obstructed Kidneys by malignant cause
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
unilateral drainage of Bilaterally Obstructed Kidneys
Intervention Description
drainage of obsructed kidneys by PCN or jj
Intervention Type
Procedure
Intervention Name(s)
bilateral drainage of Bilaterally Obstructed Kidneys
Intervention Description
drainage of obsructed kidneys by PCN or jj
Primary Outcome Measure Information:
Title
when the serum creatinine comes to normal after drainage of bilaterally obstructed kidneys either on one side or 2 sides
Description
The investigators will measure seum creatinine of patients with bilaterally obstructed kidneys and raised serum chemistry who are in urgent need for intervention . After intervention , either by PCn or ureteric stents , serum chemistry will be measured in those patient again in fixed times e.g; after 6 hrs , 1 day , 3 days , 1 week , 2 weeks . after collecting and processing the data we will come to a conclusion either bilateral drainage of patients with bilaterally obstructed kidneys due to benign cause is faster to return serum chemistry to normal than unilateral drainage. The same will be applied to patients of bilaterally obstructed kidneys due to malignant cause .
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients ( >18 yrs ) with bilateral obstructed kidneys
Bilateral obstructed kidneys due to benign causes
Bilateral obstructed kidneys due to malignant causes
Bilateral obstructed kidneys with high serum creatinine
Exclusion Criteria:
Age < 18 yrs
Bilateral obstructed kidneys with normal serum creatinine
patients with chronic kidney disease
Vesicoureteric reflux
Severe comorbidity preventing intervention
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Mode of Drainage Of Bilaterally Obstructed Kidneys
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