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

Overview

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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2011

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).

Interventions

  • 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

Primary Measures

  • Residual renal function and urine volume
    • Time Frame: Every 3 months

Secondary Measures

  • 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

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

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • 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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