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

Peritoneal Dialysis, Continuous Ambulatory Clinical Trial

— COMPASS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01887262
• Other study ID #: COMPASS
• Status: Completed
• Phase: N/A
• First received: June 24, 2013
• Last updated: April 16, 2018
• Start date: July 2013
• Est. completion date: July 2016

Study information

• Verified date: April 2018
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: July 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Peritoneal Dialysis, Continuous Ambulatory

Intervention

Device:
• BCM-guided fluid management

Procedure:
• Fluid management based on the clinical information alone

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital Clinical Trial Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Fresenius Medical Care Korea

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

Van Biesen W, Williams JD, Covic AC, Fan S, Claes K, Lichodziejewska-Niemierko M, Verger C, Steiger J, Schoder V, Wabel P, Gauly A, Himmele R; EuroBCM Study Group. Fluid status in peritoneal dialysis patients: the European Body Composition Monitoring (EuroBCM) study cohort. PLoS One. 2011 Feb 24;6(2):e17148. doi: 10.1371/journal.pone.0017148. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	delta GFR	change of glomerular filtration rate from baseline to the 12th month	baseline and 12th month
Secondary	GFR	glomerular filtration rate measured by urine collection, calculated by the mean of creatinine and urea clearance	at 12th month
Secondary	time to anuria	time to the anuric state (urine volume < 100cc/d)	over 12 months
Secondary	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
Secondary	BP	systolic, diastolic blood pressure, pulse pressure	12th month
Secondary	cardiovascular event	fatal and nonfatal cardiovascular events - acute myocardial infarction (AMI), stroke, unstable angina, amputation, cardiovascular revascularization	over 12 months
Secondary	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