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

Seoul National University Hospital108 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

108

Conditions

Peritoneal Dialysis, Continuous Ambulatory

Interventions

BCM-guided fluid managementDEVICE

Fluid management based on the clinical information alonePROCEDURE

Eligibility

Sex: ALLMin age: 20 YearsMax age: 75 Years

Medical Language ↔ Plain English

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)

Locations (1)

Seoul National University Hospital Clinical Trial Center

Seoul, South Korea

Outcomes

Primary Outcomes

delta GFR

change of glomerular filtration rate from baseline to the 12th month

Time frame: baseline and 12th month

Secondary Outcomes

GFR

glomerular filtration rate measured by urine collection, calculated by the mean of creatinine and urea clearance

Time frame: at 12th month

time to anuria

time to the anuric state (urine volume \< 100cc/d)

Time frame: 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)

Time frame: 12 months period

systolic, diastolic blood pressure, pulse pressure

Time frame: 12th month

cardiovascular event

fatal and nonfatal cardiovascular events - acute myocardial infarction (AMI), stroke, unstable angina, amputation, cardiovascular revascularization

Time frame: 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)

Time frame: baseline and 12th month

Data from ClinicalTrials.gov

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