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This study has been withdrawn prior to enrollment.
(The study was withdrawn prior to enrollment of first participant.)
Sponsor:
Information provided by:
Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT00936923
First received: July 9, 2009
Last updated: February 2, 2011
Last verified: January 2011
  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
Renal Function Disorder
Drug: furosemide
Phase 3

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

Resource links provided by NLM:


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
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).

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
China, Guangdong
The 1st Affiliated Hospital, Sun Yet-sen University
Guangzhou, Guangdong, China, 510080
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: Xueqing Yu/Director, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT00936923     History of Changes
Other Study ID Numbers: SYSU-PRGPD-diuretics
Study First Received: July 9, 2009
Last Updated: February 2, 2011
Health Authority: China: Food and Drug Administration

Keywords provided by Sun Yat-sen University:
CAPD
Diuretics
Residual Renal Function
furosemide

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Diuretics
Furosemide
Cardiovascular Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sodium Potassium Chloride Symporter Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014