Control Of Fluid Balance Guided by Body Composition Monitoring in Patients on PeritoneAl dialySiS

Study Overview
=================
Brief Summary
-----------------
Bioimpedance-guided fluid management in peritoneal dialysis patients may provide better protection of residual renal function over 1 year period, compared with management guided by clinical information alone - such as blood pressure, body weight, and physician's physical examination.

Official Title
-----------------
Control Of Fluid Balance Guided by Body Composition Monitoring in Patients on PeritoneAl dialySiS (COMPASS) Trial

Conditions
-----------------
Peritoneal Dialysis, Continuous Ambulatory

Intervention / Treatment
-----------------
* Device: BCM-guided fluid management
* Procedure: Fluid management based on the clinical information alone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age bwten 20 and 75 peritoneal dialysis > 4 weeks duration written consent daily urine output > 500 ml Exclusion Criteria: subjects who are contraindicated to the bioimpedance measurement (pacemaker insertion state, defibrillator state, amputee, prosthesis, metal implants) pregnant women subjects who are expected to discontinue peritoneal dialysis with one year mixed dialysis modality (peritoneal + hemodialysis) hypoalbuminemic subjects (serum albumin < 3.3 g/dL) high blood pressure (> 160/100 mmHg despite antihypertensive medications) severe heart failure (NYHA FC III, or IV)

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Incident peritoneal dialysis (PD) patients who are randomly allocated to BCM-guided fluid management will receive BCM measurement every two months over 1-year period. The BCM results will be notified to the physicians and the participating subjects. Based on the BCM results along with the clinical information such as blood pressure, edema and weight, the physicians will prescribe PD fluid and diuretics, targeting within 1L of overhydration status. They will prescribe dietary education to the patient, if necessary. | Device: BCM-guided fluid management<br> <br> |
| Active Comparator: Control<br>BCM will be measured at the beginning and end of the study, respectively. However, the BCM results will be blinded to the physicians and the control group. The physician will prescribe drugs, PD fluids, and dietary education to the patients based on the clinical information alone - such as blood pressure, edema and body weight. | Procedure: Fluid management based on the clinical information alone<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| delta GFR | change of glomerular filtration rate from baseline to the 12th month | baseline and 12th month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GFR | glomerular filtration rate measured by urine collection, calculated by the mean of creatinine and urea clearance | at 12th month | 
| time to anuria | time to the anuric state (urine volume < 100cc/d) | over 12 months | 
| echocardiographic parameters | parameters obtained by echocardiographic measurements such as left ventracular mass index (LVMi), E/e' ratio, left vetricular end-diastolic volume (LVEDP), left ventracular ejection fraction (LVEF), left atrial volume indx (LAVI) | 12 months period | 
| BP | systolic, diastolic blood pressure, pulse pressure | 12th month | 
| cardiovascular event | fatal and nonfatal cardiovascular events - acute myocardial infarction (AMI), stroke, unstable angina, amputation, cardiovascular revascularization | over 12 months | 
| BCM parameters | parameters measured by body composition monitoring (BCM), such as overhydration(OH), extracellular water (ECW), extracellular-to-intracellular water ratio (ECW/ICW) | baseline and 12th month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fluid, edema