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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2012-12-31

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Renal Function Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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furosemide1

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

Group Type ACTIVE_COMPARATOR

furosemide

Intervention Type DRUG

patients will take furosemide 60 or 120mg oral per day for 1 years .

furosemide 2

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

Group Type ACTIVE_COMPARATOR

furosemide

Intervention Type DRUG

patients will take furosemide 60 or 120mg oral per day for 1 years .

control

Patients in control group will not take furosemide

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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furosemide

patients will take furosemide 60 or 120mg oral per day for 1 years .

Intervention Type DRUG

Other Intervention Names

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Lasix(Diuretics)

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No