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

Renal Function Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00936923
• Other study ID #: SYSU-PRGPD-diuretics
• Status: Withdrawn
• Phase: Phase 3
• First received: July 9, 2009
• Last updated: May 19, 2015
• Start date: June 2008
• Est. completion date: December 2012

Study information

• Verified date: May 2015
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Renal Function Disorder
• Renal Insufficiency

Intervention

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

Locations

Country	Name	City	State
China	The 1st Affiliated Hospital, Sun Yet-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Residual renal function and urine volume		Every 3 months	Yes
Secondary	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	Yes