Spironolactone to Decrease Potassium Wasting in Hypercalciuric Patients Treated With Thiazide Diuretics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Change in serum potassium on spironolactone versus off of it
研究概览
简要总结
Kidney stone formation due to an excess of calcium in the urine is a common problem. It is treated with thiazide diuretics. These drugs often cause excessively low blood potassium levels that in turn require large doses of potassium supplements. These supplements are often large, unpleasant and easy to forget. We are trying the addition of spironolactone to these patients' medications to see if it allows them to take a lower dose of potassium.
详细描述
See rationale above
Ten patients who have had multiple kidney stones primarily due to hypercalciuria and who are currently on stable dose of thiazide or thiazide plus amiloride will be enrolled in the study. In addition, pts have to require at least 60mEq of K supplementation a day or be on 40mEq and be hypokalemic and unable to tolerate increased K supplements. We will then give them 50mg a day of spironolactone for four weeks. A complete 24-hour urine stone profile will be obtained before and after the drug is administered. After four weeks the patients' serum potassium will be rechecked, and their dose will be lowered according to a nomogram.
Primary end point is the mean change in serum K before and after spironolactone. Secondary endpoints are the change in urine calcium on and off the drug and the mean reduction in K dose on the drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 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
- •Age 18-65
- •History of idiopathic hypercalciuria (>200mg per 24 hours or a Ca/cr ratio of >140) felt to be the primary etiology of patient's kidney stones
- •History of at least three kidney stone events
- •On same dose of thiazide diuretic for at least three months
- •On stable dose of K 60mEq or more a day to maintain serum K >3.5 or unable to tolerate an increase in K supplement with dose at least 40mEq a day
排除标准
- •Use of ACE inhibitor, ACE receptor blocker or other medication known to effect serum potassium levels
- •GFR <80 by MDRD equation
- •Serious cardiac disease, diabetes, CKD , current or planned pregnancy or breastfeeding
- •History of hypertension
结局指标
主要结局
Change in serum potassium on spironolactone versus off of it
次要结局
- change in urinary calcium excretion
- mean reduction in dose of potassium supplements