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

Primary Purpose

End Stage Renal Disease

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
bioimpedance monitoring
clinical monitoring
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End Stage Renal Disease focused on measuring Peritoneal Dialysis, fluid overload, bioimpedance analysis, Randomized Controlled Trial

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The First Affiliated Hospital of Sun Yat-Sen University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

bioimpedance monitoring group

clinical monitoring group

Arm Description

patients whose fluid status will be monitored and guided by bioimpedance analysis

patients whose fluid status will be monitored and guided by clinical experience

Outcomes

Primary Outcome Measures

death
all cause mortality;cardiovascular related mortality

Secondary Outcome Measures

technique failure
permanent hemodialysis transfer
cardiovascular events
heart failure, myocardial infarction,angina, Percutaneous coronary stenting, coronary artery bypass grafting,
clinical adverse events
hospitalization events due to overload; Non-PD related infection; PD related peritonitis; peripheral angiopathy
residual renal function
change of baseline residual renal function, measured as residual glomerular filtration rate(rGFR) and urine volume

Full Information

First Posted
November 26, 2013
Last Updated
April 19, 2016
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT02000128
Brief Title
Fluid Management Guided by Bioimpedance Analysis in Peritoneal Dialysis(PD) Patients.
Official Title
A Prospective, Randomized Controlled Study of Bioimpedance Analysis(BIA) Guided Fluid Management in Peritoneal Dialysis Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Purpose: to investigate the effect of bioimpedance analysis(BIA) guided fluid management versus experiential way on clinical outcome in peritoneal dialysis patients. Design: prospective,randomized,controlled,single center study 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. Objects: incident and prevalent patients with overhydration status. anticipated cases:240 arms: all the patients are randomized into two arms.(BIA group/clinical group) observational time:12 months Primary Outcome: all cause mortality. Secondary Outcomes: technique survival, cardiovascular events, peritonitis, residual renal function.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease
Keywords
Peritoneal Dialysis, fluid overload, bioimpedance analysis, Randomized Controlled Trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
bioimpedance monitoring group
Arm Type
Experimental
Arm Description
patients whose fluid status will be monitored and guided by bioimpedance analysis
Arm Title
clinical monitoring group
Arm Type
Other
Arm Description
patients whose fluid status will be monitored and guided by clinical experience
Intervention Type
Device
Intervention Name(s)
bioimpedance monitoring
Other Intervention Name(s)
Multi-frequency bioelectrical impedance analysis, Body Composition Analyzer
Intervention Description
To assess the body composition using Multi-frequency bioelectrical impedance analysis
Intervention Type
Other
Intervention Name(s)
clinical monitoring
Other Intervention Name(s)
routine method of assessing water status
Intervention Description
clinical symptom and examination,such as edema, body weight, blood pressure, cardial function
Primary Outcome Measure Information:
Title
death
Description
all cause mortality;cardiovascular related mortality
Time Frame
12 months
Secondary Outcome Measure Information:
Title
technique failure
Description
permanent hemodialysis transfer
Time Frame
12 months
Title
cardiovascular events
Description
heart failure, myocardial infarction,angina, Percutaneous coronary stenting, coronary artery bypass grafting,
Time Frame
12 months
Title
clinical adverse events
Description
hospitalization events due to overload; Non-PD related infection; PD related peritonitis; peripheral angiopathy
Time Frame
12 months
Title
residual renal function
Description
change of baseline residual renal function, measured as residual glomerular filtration rate(rGFR) and urine volume
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xuqing Yu, MD,PHD
Organizational Affiliation
First Affiliated Hospital, Sun Yat-Sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Sun Yat-Sen University
City
GuangZhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China

12. IPD Sharing Statement

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

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