Effect of Diuretics on Fluid Status Control and Residual Renal Function in Peritoneal Dialysis Patients
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Residual renal function and urine volume
研究概览
简要总结
A prospective, randomized, open-label, stratified, controlled clinical trial to evaluate whether long term furosemide therapy (1 year) would preserve urine volume and/or residual renal function (RRF) and improve fluid state in continuous ambulatory peritoneal dialysis (CAPD) patients.
详细描述
There are 3 phases in this study. Phase 1 is screening phase. Each subject will be evaluated to determine if he/she is eligible for the study. Phase 2 is the intervention phage. Patients are divided arbitrarily into two groups according to baseline RRF (residual glomerular filtration rate [rGFR] <5or > 5 ml/min), then randomly received 12 months treatment with the study drugs( furosemide 120mg daily, 60mg daily, or no diuretic). Phase 3 is following-up phase, which lasts 1 year. Dialytic prescription is adjusted independent of the study and is guided by clinical parameters and calculated clearances (target creatinine clearance 65L/week, urea clearance Kt/V > 1.7 per week). Blood pressure is measured using an automated blood pressure device, and the target level is 135/85mmHg. The antihypertensive medication is introduced after the body weigh reduced into target level, and the ACEI and /or ARB selection is needed to the cross-sectional design. The hydration state is measured by bioelectrical impedance analysis (BIA).
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
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willingness to sign an informed consent
- •Age:20~70 years, regardless of gender
- •All patients received CAPD more than 1 months;
- •Urine volume of 500ml/d or more;
- •No history of taking furosemide for at least 2 weeks .
排除标准
- •Inability or unwillingness to sign the informed consent
- •Inability or unwillingness to meet the scheme demands raised by the investigators
- •Current acute infection such as peritonitis ;
- •Severe diarrhea or vomiting within the preceding 1 month
- •Acute Cardiac failure
- •Myocardial infarction within the preceding 6 months;
- •Hypertensive encephalopathy or cerebrovascular accident;
- •Accident within the preceding 6 months;
- •Any condition, such as alcohol or drug abuse, chronic liver disease, malignant disease, or psychiatric disorder;
- •Allergy or intolerance to furosemide .
- •Current or recent (within 2 weeks) exposure to any other investigational drugs
研究组 & 干预措施
furosemide1
Patients will take furosemide 60mg per day for 1 years and undergo a study assessment at 3, 6, 12, 18, 24 months .
干预措施: furosemide (Drug)
furosemide 2
Patients will take 120mg furosemide per day for 1 years and undergo a study assessment at 3, 6, 12, 18, 24 months .
干预措施: furosemide (Drug)
结局指标
主要结局
Residual renal function and urine volume
时间窗: Every 3 months
次要结局
- Dialysis adequacy, fluid status(BIA parameters: Total body water, ECW/TBW), serum Cystatin C, blood pressure, hospitalization, death from any cause,cardiovascular events, any adverse drug effects(Every 3 months)
研究者
Xue Qing Yu
Professor
Sun Yat-sen University