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
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- kidney function change
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age > 18
- •chronic kidney disease grade 4-5 (eGFR (estimated glomerular filtration rate) <30)
- •eligible to sign a consent form
排除标准
- •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
研究组 & 干预措施
catheter insertion for 2 weeks
50 randomized patients that will do urodynamic urinary examination and will be inserted urinary catheter for 2 weeks
干预措施: urinary catheter (Device)
follow up
50 randomized patients that will do urodynamic urinary examination and will be regularly followed by nephrologist
结局指标
主要结局
kidney function change
时间窗: 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
次要结局
- time to dialysis(at least 1 year from the time of catheter insertion)
研究者
Assaf Harofeh MC
Medical doctor
Assaf-Harofeh Medical Center