EUCTR2007-005365-35-FR进行中（未招募）1 期
Multicenter, parallel, controlled, randomized, single blind clinical evaluation of a new low sodium peritoneal dialysis solution on patients with hypertension treated with continous ambulatory or automated peritoneal dialysis. - PDOne
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 158
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 patients on CAPD with a minimum of 3 bag exchanges including at least one 4-6 hour dwell or patients on APD with at least one daytime exchange lasting for at least 4-6 hours
- •- Hypertensive patients with high blood pressure at inclusion (Office SBP =140 mmHg and/or DBP =90 mmHg) or hypertensive patients receiving antihypertensive medication, including diuretics, disregarding blood pressure values.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Low blood pressure (Office sitting SBP =120 mmHg and confirmed by ABPM =105 mmHg mean SBP)
- •- Symptomatic or asymptomatic ortostatic hypotension (defined as a fall in systolic OBP of at least 20 mmHg after standing for at least 1 minute)
- •- Urine volume >1500ml/24h
- •- Natremia <130 mmol/l, after two consecutive measurements
- •- Peritonits within one month prior to study start
- •- Exite site and/or tunnel infection
- •- Patients unable to tolerate 2 L bag exchanges
- •- Patients with implantable electric device (pace-maker..)
研究者
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