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

Not Applicable

Completed

• Conditions: Peritoneal Dialysis, Continuous Ambulatory
• Interventions: Procedure: Fluid management based on the clinical information alone; Device: BCM-guided fluid management

• Registration Number: NCT01887262
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-06-24
• Study First Submitted QC: 2013-06-25
• Study First Posted: 2013-06-26
• Study Start: 2013-07
• Primary Completion: 2016-05
• Study Completion: 2016-07
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-16
• Last Update Posted: 2018-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

• age bwten 20 and 75
• peritoneal dialysis > 4 weeks duration
• written consent
• daily urine output > 500 ml

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Fluid management based on the clinical information alone	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.
Intervention	BCM-guided fluid management	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.

Primary Outcome Measures

Name	Time	Method
delta GFR	baseline and 12th month	change of glomerular filtration rate from baseline to the 12th month

Secondary Outcome Measures

Name	Time	Method
GFR	at 12th month	glomerular filtration rate measured by urine collection, calculated by the mean of creatinine and urea clearance
echocardiographic parameters	12 months period	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 to anuria	over 12 months	time to the anuric state (urine volume \< 100cc/d)
BP	12th month	systolic, diastolic blood pressure, pulse pressure
cardiovascular event	over 12 months	fatal and nonfatal cardiovascular events - acute myocardial infarction (AMI), stroke, unstable angina, amputation, cardiovascular revascularization
BCM parameters	baseline and 12th month	parameters measured by body composition monitoring (BCM), such as overhydration(OH), extracellular water (ECW), extracellular-to-intracellular water ratio (ECW/ICW)

Trial Locations

Locations (1)

Seoul National University Hospital Clinical Trial Center; 🇰🇷 Seoul, Korea, Republic of