Functional Urodynamic Changes in Chronic Kidney Disease Patients and Does Insertion of Urinary Catheter Delay the Need for Kidney Dialysis

Not Applicable

• Conditions: Renal Insufficiency, Chronic

• Registration Number: NCT02731209
• Lead Sponsor: Assaf Harofeh MC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-02-22
• Status Verified: 2016-04
• Study First Submitted QC: 2016-04-02
• Last Update Submitted: 2016-04-02
• Study First Posted: 2016-04-07
• Last Update Posted: 2016-04-07
• Primary Completion: 2017-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
kidney function change	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)	measured by creatinine values mg/dL

Secondary Outcome Measures

Name	Time	Method
time to dialysis	at least 1 year from the time of catheter insertion

Trial Locations

Locations (1)

Asaf ha Rofeh, MC; 🇮🇱 Zrifin, Israel