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

NCT ID: NCT02731209

Last Updated: 2016-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Brief Summary

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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

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Conditions

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Renal Insufficiency, Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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catheter insertion for 2 weeks

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

Group Type EXPERIMENTAL

urinary catheter

Intervention Type DEVICE

follow up

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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urinary catheter

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assaf Harofeh MC

OTHER_GOV

Sponsor Role lead

Responsible Party

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Assaf Harofeh MC

Medical doctor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Asaf ha Rofeh, MC

Zrifin, , Israel

Site Status RECRUITING

Countries

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Israel

Facility Contacts

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Ilya Baberashvili, Doctor of Medicine

Role: primary

+972537346133

Guy Verhovsky, MD

Role: backup

+972548137811

Other Identifiers

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0308-15-ASF

Identifier Type: -

Identifier Source: org_study_id

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