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

May 19, 2015 updated by: Xue Qing Yu, Sun Yat-sen University
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • The 1st Affiliated Hospital, Sun Yet-sen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • Lasix(Diuretics)
No Intervention: control
Patients in control group will not take furosemide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Residual renal function and urine volume
Time Frame: Every 3 months
Every 3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Every 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Investigators

  • Principal Investigator: Xueqing Yu, MD,PhD, Department of Nephrology, 1st Affiliated Hospital, Sun Yat-Sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Anticipated)

December 1, 2011

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

July 9, 2009

First Submitted That Met QC Criteria

July 9, 2009

First Posted (Estimate)

July 10, 2009

Study Record Updates

Last Update Posted (Estimate)

May 21, 2015

Last Update Submitted That Met QC Criteria

May 19, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYSU-PRGPD-diuretics

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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