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

A Prospective, Randomized Controlled Study of Bioimpedance Analysis(BIA) Guided Fluid Management in Peritoneal Dialysis Patients.

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.

Study Overview

• Status: Completed
• Conditions: End Stage Renal Disease
• Intervention / Treatment: Device: bioimpedance monitoring; Other: clinical monitoring

• Study Type: Interventional
• Enrollment (Actual): 240
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • GuangZhou, Guangdong, China, 510080
      • The First Affiliated Hospital of Sun Yat-sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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
Other: 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 Names: routine method of assessing water status

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
death	all cause mortality;cardiovascular related mortality	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
technique failure	permanent hemodialysis transfer	12 months
cardiovascular events	heart failure, myocardial infarction,angina, Percutaneous coronary stenting, coronary artery bypass grafting,	12 months
clinical adverse events	hospitalization events due to overload; Non-PD related infection; PD related peritonitis; peripheral angiopathy	12 months
residual renal function	change of baseline residual renal function, measured as residual glomerular filtration rate(rGFR) and urine volume	12 months

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Investigators: Principal Investigator: Xuqing Yu, MD,PHD, First Affiliated Hospital, Sun Yat-Sen University

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: November 26, 2013
• First Submitted That Met QC Criteria: November 26, 2013
• First Posted (Estimate): December 3, 2013

Study Record Updates

• Last Update Posted (Estimate): April 20, 2016
• Last Update Submitted That Met QC Criteria: April 19, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial; Peritoneal Dialysis; fluid overload; bioimpedance analysis
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic
• Other Study ID Numbers: SYSU-PD-BIA