Clinical trial NCT00936923: Effect of Diuretics on Fluid Status Control and Residual Renal Function in Peritoneal Dialysis Patients
Official title: Effect of Diuretics on Fluid Status Control and Residual Renal Function in Peritoneal Dialysis Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Renal Function Disorder
Keywords: CAPD
Diuretics
Residual Renal Function
furosemide
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2009-07-10
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Residual renal function and urine volume
timeFrame: Every 3 months
Secondary outcomes:
measure: 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
timeFrame: Every 3 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The 1st Affiliated Hospital, Sun Yet-sen University
state: Guangdong
Study officials:
affiliation: Department of Nephrology, 1st Affiliated Hospital, Sun Yat-Sen University
name: Xueqing Yu, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: