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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

Tracking Information
First Submitted Date  ICMJE November 26, 2013
First Posted Date  ICMJE December 3, 2013
Last Update Posted Date April 20, 2016
Study Start Date  ICMJE November 2013
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 26, 2013)
death [ Time Frame: 12 months ]
all cause mortality;cardiovascular related mortality
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 26, 2013)
  • technique failure [ Time Frame: 12 months ]
    permanent hemodialysis transfer
  • cardiovascular events [ Time Frame: 12 months ]
    heart failure, myocardial infarction,angina, Percutaneous coronary stenting, coronary artery bypass grafting,
  • clinical adverse events [ Time Frame: 12 months ]
    hospitalization events due to overload; Non-PD related infection; PD related peritonitis; peripheral angiopathy
  • residual renal function [ Time Frame: 12 months ]
    change of baseline residual renal function, measured as residual glomerular filtration rate(rGFR) and urine volume
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fluid Management Guided by Bioimpedance Analysis in Peritoneal Dialysis(PD) Patients.
Official Title  ICMJE A Prospective, Randomized Controlled Study of Bioimpedance Analysis(BIA) Guided Fluid Management in Peritoneal Dialysis Patients.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE End Stage Renal Disease
Intervention  ICMJE
  • Device: bioimpedance monitoring
    To assess the body composition using Multi-frequency bioelectrical impedance analysis
    Other Names:
    • Multi-frequency bioelectrical impedance analysis
    • Body Composition Analyzer
  • Other: clinical monitoring
    clinical symptom and examination,such as edema, body weight, blood pressure, cardial function
    Other Name: routine method of assessing water status
Study Arms  ICMJE
  • Experimental: bioimpedance monitoring group
    patients whose fluid status will be monitored and guided by bioimpedance analysis
    Intervention: Device: bioimpedance monitoring
  • clinical monitoring group
    patients whose fluid status will be monitored and guided by clinical experience
    Intervention: Other: clinical monitoring
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 26, 2013)
240
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2015
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02000128
Other Study ID Numbers  ICMJE SYSU-PD-BIA
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Xue Qing Yu, Sun Yat-sen University
Study Sponsor  ICMJE Sun Yat-sen University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Xuqing Yu, MD,PHD First Affiliated Hospital, Sun Yat-Sen University
PRS Account Sun Yat-sen University
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP