Treatment of Asymptomatic Fluid Overload in Peritoneal Dialysis Patients
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- blood pressure control
研究概览
简要总结
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.
详细描述
The investigators plan to recruit 60 PD patients with asymptomatic fluid overload, which is defined as overhydration (OH) ≥ 2 liters as measured by bioimpedance spectroscopy. Patients with clinical symptoms of fluid overload (including, but not restricted to, dyspnea on exertion, peripheral edema, pulmonary congestion) will be excluded. The investigators will also exclude patients who are in overt pulmonary edema and required urgent medical care, who have cognitive impairment or problem of communication, unlikely to survive for more than three months, have mechanical problems of the dialysis catheter, or have active peritonitis or peritoneal failure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •asymptomatic fluid overload, defined as overhydration (OH) ≥ 2 liters as measured by bioimpedance spectroscopy
排除标准
- •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
结局指标
主要结局
blood pressure control
时间窗: 1 year
hospitalization for cardiovascular disease
时间窗: 1 year
number of antihypertensive medications
时间窗: 1 year
duration of hospitalization for all cause
时间窗: 1 year
次要结局
- degree of overhydration(1 year)
- nutritional status(1 year)
- arterial pulse wave velocity(1 year)
- change in residual GFR(1 year)
- all-cause mortality(1 year)
- cardiovascular mortality(1 year)
研究者
Cheuk-Chun SZETO
Professor
Chinese University of Hong Kong