Effect of Diuretics on Fluid Status Control and Residual Renal Function in Peritoneal Dialysis Patients

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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).

Official Title
-----------------
Effect of Diuretics on Fluid Status Control and Residual Renal Function in Peritoneal Dialysis Patients

Conditions
-----------------
Renal Function Disorder

Intervention / Treatment
-----------------
* Drug: furosemide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: furosemide1<br>Patients will take furosemide 60mg per day for 1 years and undergo a study assessment at 3, 6, 12, 18, 24 months . | Drug: furosemide<br>* patients will take furosemide 60 or 120mg oral per day for 1 years .<br>* Other names: Lasix(Diuretics);|
| Active Comparator: furosemide 2<br>Patients will take 120mg furosemide per day for 1 years and undergo a study assessment at 3, 6, 12, 18, 24 months . | Drug: furosemide<br>* patients will take furosemide 60 or 120mg oral per day for 1 years .<br>* Other names: Lasix(Diuretics);|
| No Intervention: control<br>Patients in control group will not take furosemide | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Residual renal function and urine volume |  | Every 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CAPD, Diuretics, Residual Renal Function, furosemide