Control Of Fluid Balance Guided by Body Composition Monitoring in Patients on PeritoneAl dialySiS (COMPASS) Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 1
- 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)
研究组 & 干预措施
Intervention
Incident peritoneal dialysis (PD) patients who are randomly allocated to BCM-guided fluid management will receive BCM measurement every two months over 1-year period. The BCM results will be notified to the physicians and the participating subjects. Based on the BCM results along with the clinical information such as blood pressure, edema and weight, the physicians will prescribe PD fluid and diuretics, targeting within 1L of overhydration status. They will prescribe dietary education to the patient, if necessary.
干预措施: BCM-guided fluid management (Device)
Control
BCM will be measured at the beginning and end of the study, respectively. However, the BCM results will be blinded to the physicians and the control group. The physician will prescribe drugs, PD fluids, and dietary education to the patients based on the clinical information alone - such as blood pressure, edema and body weight.
干预措施: Fluid management based on the clinical information alone (Procedure)
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