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

Renal Insufficiency, Chronic Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02731209
• Other study ID #: 0308-15-ASF
• Status: Recruiting
• Phase: N/A
• First received: February 22, 2016
• Last updated: April 2, 2016
• Start date: February 2016

Study information

• Verified date: April 2016
• Source: Assaf-Harofeh Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of HealthIsrael: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Diseases
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Device:
• urinary catheter

Locations

Country	Name	City	State
Israel	Asaf ha Rofeh, MC	Zrifin

Sponsors (1)

Lead Sponsor	Collaborator
Assaf Harofeh MC

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	kidney function change	measured by creatinine values mg/dL	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)	Yes
Secondary	time to dialysis		at least 1 year from the time of catheter insertion	Yes