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Clinical Trials/NCT01887262
NCT01887262
Completed
Not Applicable

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

Seoul National University Hospital1 site in 1 country108 target enrollmentJuly 2013
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ConditionsPeritoneal Dialysis, Continuous Ambulatory

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Peritoneal Dialysis, Continuous Ambulatory
Sponsor
Seoul National University Hospital
Enrollment
108
Locations
1
Primary Endpoint
delta GFR
Status
Completed
Last Updated
8 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

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.

Registry
clinicaltrials.gov
Start Date
July 2013
End Date
July 2016
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kook-Hwan Oh

Associate Professor

Seoul National University Hospital

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)

Outcomes

Primary Outcomes

delta GFR

Time Frame: baseline and 12th month

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

Secondary Outcomes

  • GFR(at 12th month)
  • time to anuria(over 12 months)
  • echocardiographic parameters(12 months period)
  • BP(12th month)
  • cardiovascular event(over 12 months)
  • BCM parameters(baseline and 12th month)

Study Sites (1)

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