EUCTR2007-005365-35-GB进行中（未招募）不适用
Multicenter, parallel, controlled, randimized, single-blind clinical evaluation of new low sodium peritoneal dialysis solution on patients with hypertension treated with continuous ambulatory or automated peritoneal dialysis - Evaluation of low sodium PDF in hypertensive PD patients
Fresenius Medcial Care Deutschland GmbH0 个研究点目标入组 140 人开始时间: 2012年5月15日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 140
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
- •- Chronic renal failure - Stable on PD treatment - Treated in a CAPD(Continous Ambulatory peritoneal Dialysis) or in an APD program using with a daytime bag-exchange duration of 4-6 hours using one low strength glucose bag - Hypertensive patients (Office blood pressure SBP = 140 and/or DBP = 90 mmHg) or hypertensive patients receiving antihypertensive medication including diuretics, disregarding blood pressure values (Patients in the range 120 - 140 mmHg SBP can be included if they are diagnosed for hypertension. The final decision for being eligeable is the mean 24h = 105 mmHg SBP. - Signed informed consent - Life expectancy and expected technical survival = 9 months
- •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 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •- Low blood pressure (Office sitting SBP = 120 mmHg and confirmed by ABPM = 105 mmHg mean 24 SBP) - Orthostatic hypotension defined as Systolic OBP with a drop of >20 mmHg and symptomatic after standing for at least 1 minute - Natraemia < 130 mmol/l, after two consecutive measurements - Chronic arhythmia - Peritonitis within one month prior to the study start
研究者
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