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

NCT02731209 | Unknown DMC

• 1 other identifier: 0308-15-ASF
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Insufficiency, Chronic

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (1)

• time to dialysis

  at least 1 year from the time of catheter insertion

Study Arms (2)

catheter insertion for 2 weeks

EXPERIMENTAL

50 randomized patients that will do urodynamic urinary examination and will be inserted urinary catheter for 2 weeks

Device: urinary catheter

follow up

NO INTERVENTION

50 randomized patients that will do urodynamic urinary examination and will be regularly followed by nephrologist

Interventions

urinary catheter DEVICE

catheter insertion for 2 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age \> 18
• chronic kidney disease grade 4-5 (eGFR (estimated glomerular filtration rate) \<30)
• eligible to sign a consent form

You may not qualify if:

• 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

Sponsors & Collaborators

• Assaf Harofeh MC: lead

Study Sites (1)

Asaf ha Rofeh, MC

Zrifin, 70300, Israel

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Urinary Catheters

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Catheters; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical doctor

Study Record Dates

• First Submitted: February 22, 2016
• First Posted: April 7, 2016
• Study Start: February 1, 2016
• Primary Completion: February 1, 2017
• Last Updated: April 7, 2016

Record last verified: 2016-04

Locations

IL (1)