Effect of Diuretics on Fluid Status Control and Residual Renal Function in Peritoneal Dialysis Patients
Information source: Sun Yat-sen University
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Continuous Ambulatory Peritoneal Dialysis (CAPD); Furosemide
Intervention: furosemide (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Sun Yat-sen University Official(s) and/or principal investigator(s):
Xueqing Yu, MD,PhD, Principal Investigator, Affiliation: Department of Nephrology, 1st Affiliated Hospital, Sun Yat-Sen University
Overall contact:
Xueqing Yu, MD,PhD, Phone: 8620-87766335, Email: yuxq@mail.sysu.edu.cn
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.
Clinical Details
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Residual renal function and urine volume
Secondary outcome: 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
Detailed description:
There are 3 phases in this study. Phage 1 is screening phage. Each subject will be evaluated
to determine if he/she is eligible for the study. Phage 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
Minimum age: 20 Years.
Maximum age: 70 Years.
Gender(s): Both.
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
Locations and Contacts
Xueqing Yu, MD,PhD, Phone: 8620-87766335, Email: yuxq@mail.sysu.edu.cn
The 1st Affiliated Hospital, Sun Yet-sen University, Guangzhou, Guangdong 510080, China; Recruiting
Xueqing Yu, MD,PhD, Phone: 8620-87766335, Email: yuxq@mail.sysu.edu.cn
Qiongqiong Yang, MD,PhD, Phone: 862087755766, Ext: 8843, Email: qqyzzm@yahoo.com.cn
Xueqing Yu, MD,PhD, Principal Investigator
Additional Information
Starting date: June 2008
Ending date: December 2012
Last updated: July 9, 2009
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