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

Study Overview
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Brief Summary
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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.

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

Conditions
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End Stage Renal Disease

Intervention / Treatment
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* Device: bioimpedance monitoring
* Other: clinical monitoring


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: bioimpedance monitoring group<br>patients whose fluid status will be monitored and guided by bioimpedance analysis | Device: bioimpedance monitoring<br>* To assess the body composition using Multi-frequency bioelectrical impedance analysis<br>* Other names: Body Composition Analyzer;|
| Other: clinical monitoring group<br>patients whose fluid status will be monitored and guided by clinical experience | Other: clinical monitoring<br>* clinical symptom and examination,such as edema, body weight, blood pressure, cardial function<br>* Other names: routine method of assessing water status;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peritoneal Dialysis, fluid overload, bioimpedance analysis, Randomized Controlled Trial