Research Project: Pilot Study on Oral Urea Use in Patients at High Risk of Kidney Stone Recurrence
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Change From Baseline in urine output at 1 week and 1 Month
研究概览
简要总结
In clinical practice, many patients are not able to modify their habits to achieve a high level of diuresis and fluid intake and therefore are at an elevated risk for stone recurrence.
The investigators think that Ure-Na (osmotic agent) taking could help to increase urine volume and decrease urine concentration, which would be of benefit in the prevention of kidney stones.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 60 years of age
- •High risk for recurrence (1 or more of) Bilateral or complex stones, Recurrent stones, Family history (1st degree relative), Non-calcium stones, Solitary kidney or anatomical abnormality, Nephrocalcinosis, Systemic disease with risk of stones (tubular acidosis, cystinuria, etc.)
- •Diuresis < 1.8 L/24 hours despite recommendations from physicians and/or nutritionist at the kidney stone clinic (as documented in the previous 6 months)
排除标准
- •Patient does not meet 1 of the 3 inclusion criteria
- •Pregnancy or breastfeeding
- •Lack of understanding about the protocol and effects of Ure-Na
- •Expected inability to adequately increase fluid intake on Ure-Na
研究组 & 干预措施
Open label
The study provides for a single group, which will be its own control (pre/post intervention study). Participants in the study will receive Oral Urea (Ure-Na) treatment at a dose of 30 grams per day (2 x 15 gram pouches per day) for 1 month
干预措施: Ure-Na (Drug)
结局指标
主要结局
Change From Baseline in urine output at 1 week and 1 Month
时间窗: 1 week and 1 month
variation in 24-hour diuresis and urine biochemistry
次要结局
未报告次要终点