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

April 2, 2016 updated by: Assaf Harofeh MC

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Zrifin, Israel, 70300
        • Recruiting
        • Asaf ha Rofeh, MC
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ilya Baberashvili, Doctor of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: catheter insertion for 2 weeks
50 randomized patients that will do urodynamic urinary examination and will be inserted urinary catheter for 2 weeks
Device: urinary catheter
No Intervention: follow up
50 randomized patients that will do urodynamic urinary examination and will be regularly followed by nephrologist

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
kidney function change
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)
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 Outcome Measures

Outcome Measure
Time Frame
time to dialysis
Time Frame: at least 1 year from the time of catheter insertion
at least 1 year from the time of catheter insertion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assaf Harofeh MC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Anticipated)

February 1, 2017

Study Registration Dates

First Submitted

February 22, 2016

First Submitted That Met QC Criteria

April 2, 2016

First Posted (Estimate)

April 7, 2016

Study Record Updates

Last Update Posted (Estimate)

April 7, 2016

Last Update Submitted That Met QC Criteria

April 2, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0308-15-ASF

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Renal Insufficiency, Chronic

Clinical Trials on urinary catheter

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Lebanon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe