EUCTR2012-004071-39-IT进行中（未招募）不适用
Study on the effectiveness and safety of the treatment of mild-moderate symptomatic hyponatremia due to syndrome of inappropriate secretion of antidiuretic hormone (SIADH) with Tolvaptan vs fluid restriction in patients who underwent transsphenoidal surgery for hypothalamic-pituitary disorders.
FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO DI MILANO0 个研究点开始时间: 2012年10月31日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- age >18
- •- admission to Neurosurgery Unit for pituitary surgery
- •- Serum sodium levels lower than 135 mEq/l and higher than 120 mEq/l
- •- One or more symptoms of hyponatremia
- •- Euvolemic patient
- •- Informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •- Impaired renal function(grade IV KDOQI)
- •- Liver failure
- •- Hypovolemia
- •- Hyponatremic hypovolemia
- •- Lack of sense to thirst
- •- Cotreatment with inhibitors/inductors of CYP3A4
- •- Pregnancy
- •- Brestfeeding
研究者
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