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临床试验/NCT03343743
NCT03343743已完成不适用

Changes in Renal Papillary Density After Hydration Therapy in Calcium Stone Formers

Fondazione Policlinico Universitario Agostino Gemelli IRCCS0 个研究点目标入组 25 人开始时间: 2013年6月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
25
主要终点
Changes in renal papillary density

研究概览

简要总结

Patients with recurrent calcium oxalate stones undergoing endourological procedures for renal stones at our institution from June 2013 to June 2014 were considered eligible for enrolment. Enrolled patients underwent a baseline unenhanced CT scan before the urological procedure; after endoscopic removal of their stones, the patients were instructed to drink at least 2 L/day of a hypotonic, oligomineral water low in sodium and minerals (fixed residue at 180°C <200 mg/L) for at least 12 months. Finally, the patients underwent a follow-up unenhanced CT scan during hydration regimen.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

入选标准

  • Patients undergoing endourological procedures for renal stones
  • Recurrent stone disease
  • Calcium oxalate stones (>50% of the stone made of calcium oxalate)

排除标准

  • Systemic conditions causing stones (hyperparathyroidism, intestinal malabsorption, renal tubular acidosis)
  • Non-calcium oxalate stones

研究组 & 干预措施

Hydration

Other

Patients were instructed to drink at least 2 L/day of a hypotonic, oligomineral water low in sodium and minerals (fixed residue at 180°C <200 mg/L) for at least 12 months

干预措施: Oligomineral water (Other)

结局指标

主要结局

Changes in renal papillary density

时间窗: At baseline and after 12 months

Renal papillary density measured with unenhanced CT scan

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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