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

This study has been withdrawn prior to enrollment.
(The study was withdrawn prior to enrollment of first participant.)
Information provided by (Responsible Party):
Xue Qing Yu, Sun Yat-sen University Identifier:
First received: July 9, 2009
Last updated: May 19, 2015
Last verified: May 2015
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
Renal Function Disorder
Drug: furosemide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Diuretics on Fluid Status Control and Residual Renal Function in Peritoneal Dialysis Patients

Resource links provided by NLM:

Further study details as provided by Xue Qing Yu, Sun Yat-sen University:

Primary Outcome Measures:
  • Residual renal function and urine volume [ Time Frame: Every 3 months ]

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 ]

Enrollment: 0
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
Active Comparator: furosemide1
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 .
Other Name: Lasix(Diuretics)
Active Comparator: furosemide 2
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 .
Other Name: Lasix(Diuretics)
No Intervention: control
Patients in control group will not take furosemide

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).

Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00936923

China, Guangdong
The 1st Affiliated Hospital, Sun Yet-sen University
Guangzhou, Guangdong, China, 510080
Sponsors and Collaborators
Sun Yat-sen University
Principal Investigator: Xueqing Yu, MD,PhD Department of Nephrology, 1st Affiliated Hospital, Sun Yat-Sen University
  More Information

Responsible Party: Xue Qing Yu, Professor, Sun Yat-sen University Identifier: NCT00936923     History of Changes
Other Study ID Numbers: SYSU-PRGPD-diuretics
Study First Received: July 9, 2009
Last Updated: May 19, 2015

Keywords provided by Xue Qing Yu, Sun Yat-sen University:
Residual Renal Function

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Natriuretic Agents
Physiological Effects of Drugs
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action processed this record on May 25, 2017