EUCTR2013-001189-40-EE进行中（未招募）1 期
PHARMACOKINETICS OF ORAL SPIRONOLACTONE IN CHILDREN UP TO 2 YEARS OF AGE - Pharmacokinetics of spironolactone in children
niversity of Tartu0 个研究点目标入组 27 人开始时间: 2014年10月14日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 27
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
- •Inclusion criteria
- •1.Age 35+0 weeks of gestation up to two years of age
- •2.Clinical need for spironolactone treatment due to heart failure, ascites, oedema
- •3.Clinical need for an arterial, central venous or venous catheter
- •4.Admission to study units
- •5.Informed consent by the parents or by the legitimate representative of the child.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 27
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Acute renal insufficiency, oligoanuria
- •diuresis <0.5 ml/kg/h; creatinine >100 mcmol/L
- •2.Addison's disease or other conditions associated with hyperkalemia
- •3.Hyperkalemia >5.5 mmol/l
- •4.Hyponatraemia <130.0 mmol/l
- •5.Hypersensitivity to spironolactone
- •6.Concomitant use of potassium sparing diuretics
研究者
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