Renal Insufficiency, Chronic
Conditions
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.
Interventions
DEVICEurinary catheter
Sponsors
Assaf Harofeh MC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| time to dialysis | at least 1 year from the time of catheter insertion |
Countries
Israel
Outcome results
None listed