search
Back to results

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
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Obstructive Nephropathy

Eligibility Criteria

12 Months - 3 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Adult patients ( >18 yrs ) with bilateral obstructed kidneys
  2. Bilateral obstructed kidneys due to benign causes
  3. Bilateral obstructed kidneys due to malignant causes
  4. Bilateral obstructed kidneys with high serum creatinine

Exclusion Criteria:

  1. Age < 18 yrs
  2. Bilateral obstructed kidneys with normal serum creatinine
  3. patients with chronic kidney disease
  4. Vesicoureteric reflux
  5. 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

    First Posted
    August 23, 2019
    Last Updated
    August 30, 2019
    Sponsor
    Assiut University
    search

    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

    We'll reach out to this number within 24 hrs