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.
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: December 2011
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).
- Drug: furosemide
- patients will take furosemide 60 or 120mg oral per day for 1 years .
Arms, Groups and Cohorts
- Active Comparator: furosemide1
- Patients will take furosemide 60mg per day for 1 years and undergo a study assessment at 3, 6, 12, 18, 24 months .
- Active Comparator: furosemide 2
- Patients will take 120mg furosemide per day for 1 years and undergo a study assessment at 3, 6, 12, 18, 24 months .
- No Intervention: control
- Patients in control group will not take furosemide
Clinical Trial Outcome Measures
- Residual renal function and urine volume
- Time Frame: Every 3 months
- 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
- Time Frame: Every 3 months
Participating in This Clinical Trial
- 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 . Exclusion Criteria:
- 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
Gender Eligibility: All
Minimum Age: 20 Years
Maximum Age: 70 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Sun Yat-sen University
- Provider of Information About this Clinical Study
- Principal Investigator: Xue Qing Yu, Professor – Sun Yat-sen University
- Overall Official(s)
- Xueqing Yu, MD,PhD, Principal Investigator, Department of Nephrology, 1st Affiliated Hospital, Sun Yat-Sen University
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