Prospective Evaluation of the Effect of Different Intervals Between Extracorporeal Shock Wave Lithotripsy (ESWL) Sessions on Potential Renal Injury Using Urinary NGAL and KIM-1 Biomarkers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in urinary NGAL level
研究概览
简要总结
The goal of this prospective observational study is to evaluate the effect of different time intervals between extracorporeal shock wave lithotripsy (ESWL) sessions on renal injury using urinary biomarkers in patients with urinary system stone disease.
The main questions it aims to answer are:
Does the interval between consecutive ESWL sessions affect the degree of renal injury?
Are urinary NGAL and KIM-1 levels reliable biomarkers for detecting ESWL-related renal damage?
What is the optimal time interval between ESWL sessions to minimize renal injury?
If there is a comparison group, researchers will compare patients undergoing ESWL with different inter-session time intervals to determine whether shorter or longer intervals are associated with higher levels of renal injury biomarkers.
Participants will:
Undergo ESWL treatment for urinary system stones
Be assigned to one of two groups based on the time interval between ESWL sessions
Provide urine samples before ESWL and after three ESWL sessions
Have urinary NGAL and KIM-1 levels measured to assess renal injury
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 18 years and older
- •Patients with an indication for extracorporeal shock wave lithotripsy (SWL) for urinary system stone disease
排除标准
- •Positive nitrite on urinalysis prior to SWL
- •Positive urine culture prior to SWL, defined as >10⁵ CFU/mL bacterial growth
- •Suspected struvite stone, based on previous or partial stone analysis
- •Presence of a nephrostomy tube
- •Presence of urinary diversion
- •History of bleeding disorders
- •Pregnancy
- •Use of anticoagulant therapy
- •History of cardiac arrhythmia
结局指标
主要结局
Change in urinary NGAL level
时间窗: Within 2 weeks after completion of the third SWL session
Difference in urinary NGAL levels measured before SWL and after completion of three SWL sessions
Change in urinary KIM-1 levels
时间窗: Within 2 weeks after completion of the third SWL session
Difference in urinary KIM-1 levels measured before SWL and after completion of three SWL sessions
次要结局
- Between-group difference in change of urinary NGAL and KIM-1 levels according to SWL session intervals(Within 2 weeks after completion of the third SWL session)