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Fluid Management Guided by Bioimpedance Analysis in Peritoneal Dialysis(PD) Patients.

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ClinicalTrials.gov Identifier: NCT02000128
Recruitment Status : Completed
First Posted : December 3, 2013
Last Update Posted : April 20, 2016
Sponsor:
Information provided by (Responsible Party):
Xue Qing Yu, Sun Yat-sen University

Brief Summary:
  1. Purpose: to investigate the effect of bioimpedance analysis(BIA) guided fluid management versus experiential way on clinical outcome in peritoneal dialysis patients.
  2. Design: prospective,randomized,controlled,single center study
  3. Study hypothesis: Patients on peritoneal dialysis are frequently hypervolemic, which is associated with increasing hazard of death and cardiovascular events. Bioimpedance analysis is a safe, and easy way, which appears to be more useful and sensitive than other techniques for assessing volume status in dialysis patients. Therefore we hypothesize that more concise and strict fluid management guided by BIA may help to improve patients' survival, decrease cardiovascular events and hospitalization rate.
  4. Objects: incident and prevalent patients with overhydration status.

    1. anticipated cases:240
    2. arms: all the patients are randomized into two arms.(BIA group/clinical group)
    3. observational time:12 months
  5. Primary Outcome: all cause mortality. Secondary Outcomes: technique survival, cardiovascular events, peritonitis, residual renal function.

Condition or disease Intervention/treatment Phase
End Stage Renal Disease Device: bioimpedance monitoring Other: clinical monitoring Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized Controlled Study of Bioimpedance Analysis(BIA) Guided Fluid Management in Peritoneal Dialysis Patients.
Study Start Date : November 2013
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arm Intervention/treatment
Experimental: bioimpedance monitoring group
patients whose fluid status will be monitored and guided by bioimpedance analysis
Device: bioimpedance monitoring
To assess the body composition using Multi-frequency bioelectrical impedance analysis
Other Names:
  • Multi-frequency bioelectrical impedance analysis
  • Body Composition Analyzer

clinical monitoring group
patients whose fluid status will be monitored and guided by clinical experience
Other: clinical monitoring
clinical symptom and examination,such as edema, body weight, blood pressure, cardial function
Other Name: routine method of assessing water status




Primary Outcome Measures :
  1. death [ Time Frame: 12 months ]
    all cause mortality;cardiovascular related mortality


Secondary Outcome Measures :
  1. technique failure [ Time Frame: 12 months ]
    permanent hemodialysis transfer

  2. cardiovascular events [ Time Frame: 12 months ]
    heart failure, myocardial infarction,angina, Percutaneous coronary stenting, coronary artery bypass grafting,

  3. clinical adverse events [ Time Frame: 12 months ]
    hospitalization events due to overload; Non-PD related infection; PD related peritonitis; peripheral angiopathy

  4. residual renal function [ Time Frame: 12 months ]
    change of baseline residual renal function, measured as residual glomerular filtration rate(rGFR) and urine volume



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients who are undergoing peritoneal dialysis and clinically stable for at least 3 months;
  • 18 Years and older;
  • ratio extracellular water (ECW)/total body water(TBW)≧0.4;
  • signed the informed consent

Exclusion Criteria:

  • patients who have mental graft;
  • amputation;
  • patients who is unable to accomplish the BIA measurement in standing position for 3 minutes;
  • patients whose heart function are class IV estimated by New York Heart Association (NYHA) standard;
  • Patients who have acute complications within 30 days prior to study enrollment;
  • patients whose life expectancy is within 6 months;
  • patients who are pregnant;
  • patients who are unable to give consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02000128


Locations
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China, Guangdong
The First Affiliated Hospital of Sun Yat-Sen University
GuangZhou, Guangdong, China, 510080
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Principal Investigator: Xuqing Yu, MD,PHD First Affiliated Hospital, Sun Yat-Sen University
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Responsible Party: Xue Qing Yu, Director, Institute of Nephrology, Sun Yat-sen University, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02000128    
Other Study ID Numbers: SYSU-PD-BIA
First Posted: December 3, 2013    Key Record Dates
Last Update Posted: April 20, 2016
Last Verified: April 2016
Keywords provided by Xue Qing Yu, Sun Yat-sen University:
Peritoneal Dialysis
fluid overload
bioimpedance analysis
Randomized Controlled Trial
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency