NCT01887262已完成不适用
Control Of Fluid Balance Guided by Body Composition Monitoring in Patients on PeritoneAl dialySiS (COMPASS) Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- delta GFR
研究概览
简要总结
Bioimpedance-guided fluid management in peritoneal dialysis patients may provide better protection of residual renal function over 1 year period, compared with management guided by clinical information alone - such as blood pressure, body weight, and physician's physical examination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age bwten 20 and 75
- •peritoneal dialysis > 4 weeks duration
- •written consent
- •daily urine output > 500 ml
排除标准
- •subjects who are contraindicated to the bioimpedance measurement (pacemaker insertion state, defibrillator state, amputee, prosthesis, metal implants)
- •pregnant women
- •subjects who are expected to discontinue peritoneal dialysis with one year
- •mixed dialysis modality (peritoneal + hemodialysis)
- •hypoalbuminemic subjects (serum albumin < 3.3 g/dL)
- •high blood pressure (> 160/100 mmHg despite antihypertensive medications)
- •severe heart failure (NYHA FC III, or IV)
结局指标
主要结局
delta GFR
时间窗: baseline and 12th month
change of glomerular filtration rate from baseline to the 12th month
次要结局
- GFR(at 12th month)
- time to anuria(over 12 months)
- echocardiographic parameters(12 months period)
- BP(12th month)
- cardiovascular event(over 12 months)
- BCM parameters(baseline and 12th month)
研究者
Kook-Hwan Oh
Associate Professor
Seoul National University Hospital
研究点 (2)
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