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

Sun Yat-sen University

Status and phase: Withdrawn; Phase 3

Conditions: Renal Function Disorder

Treatments: Drug: furosemide

Study type: Interventional

Funder types: Other

Identifiers

NCT00936923

SYSU-PRGPD-diuretics

Details and patient eligibility

About

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.

Full 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).

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 3 patient groups

furosemide1

Active Comparator group

Description:

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

Treatment:

Drug: furosemide

furosemide 2

Active Comparator group

Description:

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

Treatment:

Drug: furosemide

control

No Intervention group

Description:

Patients in control group will not take furosemide