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临床试验/NCT06819553
NCT06819553进行中(未招募)2 期

Efficacy of Oral Potassium Citrate in Reducing Ureteral Stent Encrustation Post-Ureteroscopy

Zagazig University1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2024年11月3日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
进行中(未招募)
入组人数
48
试验地点
1
主要终点
the rate of encrustation on the ureteral stents, which will be assessed after stent removal using a modified scoring system.

研究概览

简要总结

This randomized clinical trial aims to evaluate the efficacy of oral potassium citrate in reducing ureteral stent encrustation following ureteroscopy for uric acid kidney stones. The study will assess whether potassium citrate, by raising urinary pH, can prevent encrustation on stents, potentially improving patient outcomes and reducing complications.

详细描述

Urolithiasis, particularly uric acid stones, is a prevalent condition with increasing incidence due to factors such as obesity and dietary habits. Ureteroscopy with stent placement is a common intervention for managing ureteral stones. However, the indwelling stents are prone to encrustation, which can lead to significant complications, including infection, obstruction, and discomfort for patients.

Potassium citrate, an alkalinizing agent, has been shown to prevent uric acid stone formation by raising urinary pH and dissolving existing stones. This trial aims to determine whether potassium citrate can also reduce encrustation on ureteric stents following ureteroscopy for uric acid stones.

In this prospective, randomized, controlled trial, patients undergoing ureteroscopy with stent placement for uric acid stones will be randomly assigned to either the intervention group (receiving potassium citrate) or a control group. The primary outcome is the rate of stent encrustation, which will be assessed using a modified scoring system after stent removal. Secondary outcomes include serum electrolyte levels, adverse events, and changes in urinary pH. All patients will be monitored regularly for changes in urine pH and adverse events during the study.

The findings from this trial may provide valuable insights into the role of potassium citrate in preventing ureteric stent encrustation, ultimately improving patient outcomes and reducing the need for additional interventions.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Intervention Arm (Experimental Arm)Patients receiving potassium citrate.

Experimental

Oral potassium citrate (15 meq twice daily) to maintain urinary pH between 6.8 and 7.2.

干预措施: Oral Potassium Citrate (Drug)

结局指标

主要结局

the rate of encrustation on the ureteral stents, which will be assessed after stent removal using a modified scoring system.

时间窗: Stent removal, typically 4-6 weeks after ureteroscopy.

The degree of encrustation on ureteral stents will be assessed using a modified encrustation scoring system upon stent removal. Encrustation severity will be categorized based on deposition on the stent surface, graded from no encrustation to severe encrustation. Stents will be examined macroscopically and, if applicable, under microscopy for calcium and uric acid deposits.

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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