POTASSIUM-MAGNESIUM CITRATE TRIAL IN PATIENTS COMPLETING LITHOTRIPSY

在完成碎石术的患者中进行柠檬酸钾镁试验

• 批准号: 6564155
• 负责人: MARGARET S. PEARLE
• 金额: $ 22.85万
• 依托单位: UT SOUTHWESTERN MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-12-01 至 2002-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6564155
• 关键词: citrates; clinical research; clinical trials; crystallization; disease /disorder etiology; human subject; human therapy evaluation; hypercalciuria; kidney disorder chemotherapy; lithotripsy; magnesium; nephrolithiasis; outcomes research; potassium; relapse /recurrence

Description: (Taken directly from the application) The overall goal of this project is to seek a safe alternative to potassium citrate in normocalciuric nephrolithiasis. This goal will be pursued by obtaining validation of the efficacy and safety of K-Mag in an already completed randomized trial, and show that this treatment is particularly effective in normocalciuric patients than in hypercalciuric patients. Thus, a multiclinic, placebo-controlled randomized trail will be conducted with K-Mag. Participating patients will be those with recurrent calcium nephrolithiasis suffering from uncomplicated calcium stone disease who have recently undergone extracorporeal shock Wave Lithotripsy (ESWL) for removal of stones. Both normocalciuric and hypercalciuric patients will be enrolled. The treatment outcome will be analyzed by survival probability (percentage of patients remaining stone-free). The project will test the hypothesis that: 1 K-Mag would be more effective than placebo in inhibiting stone formation in both normocalciuric and hypercalciuric patients, 2 The response of normocalciuric patients K-Mag would be superior to that of hypercalciuric patients, due to the pathogenetic role of hypercalciuria, and 3 The propensity from recurrent stone formation is unaffected by ESWL, thus emphasizing the importance of medical management.

描述：（直接从申请中获取）这个项目的总体目标是寻求一种安全的柠檬酸钾替代治疗正常钙尿酸肾结石。这一目标将通过在一项已经完成的随机试验中验证K-Mag的有效性和安全性来实现，并表明这种治疗对正常钙血症患者比高钙血症患者特别有效。因此，将对K-Mag进行多诊所、安慰剂对照的随机试验。参与研究的患者将是那些患有复发性钙性肾结石且患有无并发症的钙性肾结石疾病的患者，他们最近接受了体外冲击波碎石术（ESWL）以取出结石。正常钙和高钙患者都将被纳入研究。治疗结果将通过生存率（无结石患者的百分比）进行分析。该项目将验证以下假设：1 K-Mag在抑制正常钙血症和高钙血症患者的结石形成方面比安慰剂更有效；2由于高钙血症的致病作用，正常钙血症患者的K-Mag反应优于高钙血症患者；3复发性结石形成的倾向不受ESWL的影响，从而强调医疗管理的重要性。