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

Phase 3

Withdrawn

• Conditions: Renal Function Disorder
• Interventions: Drug: furosemide

• Registration Number: NCT00936923
• Lead Sponsor: Sun Yat-sen University

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).

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2009-07-09
• Study First Submitted QC: 2009-07-09
• Study First Posted: 2009-07-10
• Primary Completion: 2011-12
• Study Completion: 2012-12
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-19
• Last Update Posted: 2015-05-21

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 .

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
furosemide1	furosemide	Patients will take furosemide 60mg per day for 1 years and undergo a study assessment at 3, 6, 12, 18, 24 months .
furosemide 2	furosemide	Patients will take 120mg furosemide per day for 1 years and undergo a study assessment at 3, 6, 12, 18, 24 months .

Primary Outcome Measures

Name	Time	Method
Residual renal function and urine volume	Every 3 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

The 1st Affiliated Hospital, Sun Yet-sen University; 🇨🇳 Guangzhou, Guangdong, China