Effect of Diuretics on Fluid Status Control and Residual Renal Function in Peritoneal Dialysis Patients - Full Text View

Sponsor:	Sun Yat-sen University
Information provided by:	Sun Yat-sen University
ClinicalTrials.gov Identifier:	NCT00936923

Purpose

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.

Condition	Intervention	Phase
Continuous Ambulatory Peritoneal Dialysis (CAPD) Furosemide	Drug: furosemide	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Resource links provided by NLM:

MedlinePlus related topics: Kidney Failure Urine and Urination

Drug Information available for: Furosemide

U.S. FDA Resources

Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:

Residual renal function and urine volume [ Time Frame: Every 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 [ Time Frame: Every 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	240
Study Start Date:	June 2008
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
furosemide1: Active Comparator Patients will take furosemide 60mg per day for 1 years and undergo a study assessment at 3, 6, 12, 18, 24 months .	Drug: furosemide patients will take furosemide 60 or 120mg oral per day for 1 years .
furosemide 2: Active Comparator Patients will take 120mg furosemide per day for 1 years and undergo a study assessment at 3, 6, 12, 18, 24 months .	Drug: furosemide patients will take furosemide 60 or 120mg oral per day for 1 years .
control: No Intervention Patients in control group will not take furosemide

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

Ages Eligible for Study:	20 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00936923

Contacts

Contact: Xueqing Yu, MD,PhD	8620-87766335	yuxq@mail.sysu.edu.cn
Contact: Qiongqiong Yang, MD,PhD	8620-87755766 ext 8843	qqyzzm@yahoo.com.cn

Locations

China, Guangdong
The 1st Affiliated Hospital, Sun Yet-sen University	Recruiting
Guangzhou, Guangdong, China, 510080
Contact: Xueqing Yu, MD,PhD 8620-87766335 yuxq@mail.sysu.edu.cn
Contact: Qiongqiong Yang, MD,PhD 862087755766 ext 8843 qqyzzm@yahoo.com.cn
Principal Investigator: Xueqing Yu, MD,PhD

Sponsors and Collaborators

Sun Yat-sen University

Investigators

Principal Investigator:

Xueqing Yu, MD,PhD

Department of Nephrology, 1st Affiliated Hospital, Sun Yat-Sen University

More Information

No publications provided

Responsible Party:	Sun Yat-sen University ( Xueqing Yu/Director )
Study ID Numbers:	SYSU-PRGPD-diuretics
Study First Received:	July 9, 2009
Last Updated:	July 9, 2009
ClinicalTrials.gov Identifier:	NCT00936923 History of Changes
Health Authority:	China: State Food and Drug Administration

Keywords provided by Sun Yat-sen University:

CAPD
Diuretics
Residual Renal Function

Additional relevant MeSH terms:

Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Therapeutic Uses
Physiological Effects of Drugs

Diuretics
Cardiovascular Agents
Sodium Potassium Chloride Symporter Inhibitors
Furosemide
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 04, 2010