EUCTR2011-005271-16-GB进行中（未招募）1 期
Does oral sodium bicarbonate therapy improve function and quality of life in older patients with chronic kidney disease and low-grade acidosis? A multicentre randomized placebo controlled trial - Bicarbonate for older Chronic Kidney Disease patients with Acidosis
niversity of Dundee & NHS Tayside0 个研究点目标入组 380 人开始时间: 2012年10月25日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 380
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
- •Aged 60 and over
- •CKD stages 4 and 5 (measured by estimated glomerular filtration rate < 30ml/min) Serum bicarbonate/CO2 levels of <22mmol/L
- •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 70
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 290
排除标准
- •Already taking bicarbonate therapy
- •Documented renal tubular acidosis (a rare, but separate condition)
- •On dialysis or anticipated to start within 3 months
- •Severe cognitive impairment precluding written informed consent
- •Decompensated chronic heart failure
- •Bisphosphonate therapy
- •Uncontrolled hypertension (BP>150/90 despite use of four agents unless in the opinion of the local PI there is evidence of adequate BP control from 24 hour BP monitoring, home BP monitoring or primary care BP records)
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