Bioimpedance-guided Fluid Management in Chronic Peritoneal Dialysis Patients.

Study Overview
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Brief Summary
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Peritoneal dialysis (PD) is one of established treatments in the end stage renal disease patients. Volume overload is a predictor of mortality in PD patients. In this Randomized controlled trial, the investigators use the Body Composition Monitor (BCM), a multifrequency bioimpedance device, to measure the level of overhydration in PD patients and explore its value in fluid management in peritoneal dialysis patients as well as their prognosis.

Detailed Description
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Optimal fluid management is one of the primary objectives of dialysis treatment, and there is significant concern that peritoneal dialysis (PD) patients can become progressively fluid-loaded with time on treatment, especially as residual kidney function declines. Body Composition Monitor (BCM) has the potential to enable better management of fluid balance. The investigators undertake a prospective, randomized, open-label, controlled trial to determine whether availability of longitudinal BCM measures help clinicians maintain stable fluid status over 24 months in 300 peritoneal dialysis patients.

Official Title
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Bioimpedance-guided Fluid Management in Chronic Peritoneal Dialysis Patients: A Randomized Controlled Trial

Conditions
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End Stage Renal Disease

Intervention / Treatment
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* Device: Body composition monitor
* Device: clinical indexes


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients 18 years or older but no older than 80 years. who had been on chronic peritoneal dialysis for more than 3 months. All of them have signed the informed consent. Exclusion Criteria: were expected to stop PD treatment in 6 months; were amputees; had a cardiac pacemaker or metallic implants; had peritonitis one month before recruitment; treated together with hemodialysis; were during pregnancy or lactation; were positive with HIV; had serious diseases, including cancer, infection and liver cirrhosis, which were not suitable for the study.

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 |
| --- | --- |
| Active Comparator: clinical group<br>evaluate the volume status just according to clinical indexes in this group. | Device: clinical indexes<br>* The investigators evaluate the volume status of patients according to clinical indexes.<br>|
| Experimental: clinical and BCM group<br>Both body composition monitor (BCM) and clinical indexes are used to evaluate the volume status of patients in this group. | Device: Body composition monitor<br>* Both body composition monitor (BCM) is used to evaluate the volume status of patients.<br>Device: clinical indexes<br>* The investigators evaluate the volume status of patients according to clinical indexes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| volume status | change in overhydration(OH) value | 96 weeks | 
| The incidence of cardiovascular events | different incidence of cardiovascular diseases | 96 weeks | 
| patient mortality | different rates of all-cause patient mortality and cardiovascular mortality | 96 weeks | 
| technique failure | different incidence of technique failure during peritoneal dialysis treatment | 96 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood pressure | change in blood pressure | 96 weeks | 
| residual renal function | decline rate of residual renal function | 96 weeks | 
| peritoneal function | differences of peritoneal solute transport rate | 96 weeks | 
| heart function | differences of ejection fraction (EF) in echocardiography | 96 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peritoneal Dialysis, Volume Status, Body Composition Monitor