Treatment of Asymptomatic Fluid Overload in Peritoneal Dialysis Patients
INTRODUCTION Peritoneal dialysis (PD) is a life-saving treatment for end-stage renal disease patients. However, cardiovascular disease remains the major cause of morbidity and mortality in PD patients. It is now realized that chronic asymptomatic intravascular hypervolemia is an important cause of cardiovascular disease in PD patients.
OBJECTIVES To determine the effects of treating asymptomatic fluid overload on blood pressure, hospitalization and cardiovascular morbidity in PD patients.
HYPOTHESIS The investigators hypothesize that treating asymptomatic fluid overload could improve the clinical outcome of PD patients.
DESIGN & SUBJECTS This is an open label randomized control trial. The investigators plan to recruit 60 PD patients with asymptomatic fluid overload, defined as overhydration (OH) ≥ 2 liters. Patients will be randomized to active fluid management (treatment arm) or conventional management (control arm).
STUDY INSTRUMENTS Overhydration will be identified by bioimpedance spectroscopy.
INTERVENTIONS For the treatment arm, active fluid management includes dietary counseling, diuretics, and intensive dialysis regimen. For the control arm, patients will only receive dietary counseling. Patients will be followed for one year.
MAIN OUTCOME MEASURES Blood pressure control, number of hospital admission and duration of hospitalization for all cause, and hospitalization for cardiovascular disease during the study period.
DATA ANALYSIS Blood pressure control will be compared by Student's t test. Hospitalization data will be compared by non-parametric Mann Whitney U test.
EXPECTED RESULTS The study will determine the benefit of treating asymptomatic fluid overload in PD patients.
研究概览
详细说明
研究类型
阶段
- 第四阶段
联系人和位置
学习地点
-
-
-
Shatin、香港
- Prince of Wales Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- asymptomatic fluid overload, defined as overhydration (OH) ≥ 2 liters as measured by bioimpedance spectroscopy
Exclusion Criteria:
- clinical symptoms of fluid overload (including, but not restricted to, dyspnea on exertion, peripheral edema, pulmonary congestion)
- overt pulmonary edema and required urgent medical care
- cognitive impairment or problem of communication
- unlikely to survive for more than three months
- mechanical problems of the dialysis catheter
- active peritonitis or peritoneal failure
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:treatment arm
active fluid management includes 3 components: dietary counseling, diuretics, and intensive dialysis regimen
|
Hypertonic peritoneal dialysis cycles
Dietary counseling
|
|
有源比较器:control arm
dietary counseling alone
|
Dietary counseling
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
blood pressure control
大体时间:1 year
|
1 year
|
|
number of antihypertensive medications
大体时间:1 year
|
1 year
|
|
duration of hospitalization for all cause
大体时间:1 year
|
1 year
|
|
hospitalization for cardiovascular disease
大体时间:1 year
|
1 year
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
全因死亡率
大体时间:1年
|
1年
|
|
degree of overhydration
大体时间:1 year
|
1 year
|
|
change in residual GFR
大体时间:1 year
|
1 year
|
|
nutritional status
大体时间:1 year
|
1 year
|
|
arterial pulse wave velocity
大体时间:1 year
|
1 year
|
|
cardiovascular mortality
大体时间:1 year
|
1 year
|
其他结果措施
结果测量 |
大体时间 |
|---|---|
|
cause of hospital admission
大体时间:1 year
|
1 year
|
合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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