Differences in Urine Neutrophil Gelatinase-Associated Lipocalin (NGAL) Levels in Patients Undergoing Retrograde Intrarenal Surgery (RIRS) With or Without Ureteral Access Sheath (UAS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Urine NGAL level (ng/mL)
研究概览
简要总结
This study will include patients aged between 18 and 65 who will undergo retrograde infrarenal surgery (RIRS) due to renal stone(s). A total of 60 patients (male or female) will be recruited, and will be randomized into 2 groups consisting of 30 patients in each group. The first group of patients will undergo RIRS with a ureteral access sheath (UAS) positioned prior to surgery; and the second group will undergo RIRS without UAS. As use of UAS decreases the pressure in the renal pelvis during RIRS, it is aimed to evaluate whether using UAS or not affects the kidney functions. besides the routine kidney function tests, namely urea and creatinine, neutrophil gelatinase-associated lipocalin (NGAL) (a more specific and early marker of kidney function) will be used to assess the differences in the kidney functions. Preoperative blood urea and creatinine levels and urine NGAL levels will be studied for all patients. After the surgery, blood urea and creatinine levels will be again studied as well as urine NGAL levels at postoperative 2nd hour, 72nd hour and 1st week.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being between 18-65 years old
- •Having an indication of retrograde infrarenal surgery (RIRS) due to kidney stone
排除标准
- •Patients with uncontrolled diabetes mellitus and diabetic nephropathy
- •Patients with blood pressure > 140/80 mmHg despite regular use of antihypertensive agent(s)
- •Patients with chronic kidney failure who need dialysis
- •Patients who have had prerenal, renal or postrenal acute kidney failure 3 months or much earlier
- •Patients who have had pyelonephritis 3 months or much earlier
- •Patients younger than 18 years or older than 65 years
- •Patients who have undergone a kidney surgery within the last 3 months and have abnormal kidney function tests
- •Patients with a concomitant ureter stone who will undergo an endoscopic ureter stone treatment at the same session
结局指标
主要结局
Urine NGAL level (ng/mL)
时间窗: Within the first 7 days after surgery (RIRS)
Determination of any impairment in renal function when ureteral access sheath is not used during RIRS by measuring urine NGAL level.
次要结局
- Blood urea level (mg/dL) and creatinine level (mg/dL)(Within the first 7 days after surgery (RIRS))
研究者
Ozcan Kilic
Associate Professor, M.D.
Selcuk University