Back to resultsFunctional Urodynamic Changes in Chronic Kidney Disease Patients and Does Insertion of Urinary Catheter Delay the Need for Kidney Dialysis
Primary Purpose
Renal Insufficiency, Chronic
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
urinary catheter
Sponsored by
About this trial
This is an interventional treatment trial for Renal Insufficiency, Chronic
Eligibility Criteria
Inclusion Criteria:
- age > 18
- chronic kidney disease grade 4-5 (eGFR (estimated glomerular filtration rate) <30)
- eligible to sign a consent form
Exclusion Criteria:
- non controlled Diabetes Melitus (HbA1C>10%)
- not controlled HTN (Hypertension)
- cardiovascular event requiring cardiac stenting
- renal hydronephrosis or post void rest > 200CC according to US (Ultrasound)
- acute renal failure
- not eligible for urodynamics for any reason
- constant urinary catheter for any reason
Sites / Locations
- Asaf ha Rofeh, MCRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
catheter insertion for 2 weeks
follow up
Arm Description
50 randomized patients that will do urodynamic urinary examination and will be inserted urinary catheter for 2 weeks
50 randomized patients that will do urodynamic urinary examination and will be regularly followed by nephrologist
Outcomes
Primary Outcome Measures
kidney function change
measured by creatinine values mg/dL
Secondary Outcome Measures
time to dialysis
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02731209
Brief Title
Functional Urodynamic Changes in Chronic Kidney Disease Patients and Does Insertion of Urinary Catheter Delay the Need for Kidney Dialysis
Official Title
Functional Urodynamic Changes in Chronic Kidney Disease Patients and Does Insertion of Urinary Catheter in Chronic Kidney Disease Patients Grade 4 Delay the Need for Kidney Dialysis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
February 2016 (undefined)
Primary Completion Date
February 2017 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Assaf Harofeh MC
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of the investigators work is to describe the urodynamic results in the CKD (chronic kidney disease) grade 4 patients and to verify observations that urinary catheter may improve kidney function in those patients.
100 patients with CKD grade 4 will do urodynamic examination.
All patients will be randomized into two groups / the intervention group that will be inserted urinary catheter for 2 weeks and the follow up group. Kidney function will be monitored by creatinin values and the investigators will measure the time to dialysis in the two groups.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Insufficiency, Chronic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
catheter insertion for 2 weeks
Arm Type
Experimental
Arm Description
50 randomized patients that will do urodynamic urinary examination and will be inserted urinary catheter for 2 weeks
Arm Title
follow up
Arm Type
No Intervention
Arm Description
50 randomized patients that will do urodynamic urinary examination and will be regularly followed by nephrologist
Intervention Type
Device
Intervention Name(s)
urinary catheter
Primary Outcome Measure Information:
Title
kidney function change
Description
measured by creatinine values mg/dL
Time Frame
At the time of urinary catheter insertion. Two weeks from the insertion and than after 8,16, 24, 32, 40 and 48 weeks after the urinary catheter insertion. (at total 52 weeks of follow up)
Secondary Outcome Measure Information:
Title
time to dialysis
Time Frame
at least 1 year from the time of catheter insertion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age > 18
chronic kidney disease grade 4-5 (eGFR (estimated glomerular filtration rate) <30)
eligible to sign a consent form
Exclusion Criteria:
non controlled Diabetes Melitus (HbA1C>10%)
not controlled HTN (Hypertension)
cardiovascular event requiring cardiac stenting
renal hydronephrosis or post void rest > 200CC according to US (Ultrasound)
acute renal failure
not eligible for urodynamics for any reason
constant urinary catheter for any reason
Facility Information:
Facility Name
Asaf ha Rofeh, MC
City
Zrifin
ZIP/Postal Code
70300
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ilya Baberashvili, Doctor of Medicine
Phone
+972537346133
Email
iliav@asaf.health.gov.il
First Name & Middle Initial & Last Name & Degree
Guy Verhovsky, MD
Phone
+972548137811
Email
guy.verchovsky@gmail.com
First Name & Middle Initial & Last Name & Degree
Ilya Baberashvili, Doctor of Medicine
12. IPD Sharing Statement
Learn more about this trial
Functional Urodynamic Changes in Chronic Kidney Disease Patients and Does Insertion of Urinary Catheter Delay the Need for Kidney Dialysis
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