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OpenTrials
Completed

NCT Number: NCT01887262

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

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.

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Key information

Conditions

Peritoneal Dialysis, Continuous Ambulatory Edema Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital Clinical Trial Center

Seoul, 110-744, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

BCM-guided fluid management

Device

Fluid management based on the clinical information alone

Procedure

Primary outcomes

  1. delta GFR

    Time frame: baseline and 12th month

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

Secondary outcomes

  1. GFR

    Time frame: at 12th month

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

  2. time to anuria

    Time frame: over 12 months

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

  3. echocardiographic parameters

    Time frame: 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)

  4. BP

    Time frame: 12th month

    systolic, diastolic blood pressure, pulse pressure

  5. cardiovascular event

    Time frame: over 12 months

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

  6. BCM parameters

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Fresenius Medical Care Korea

Registry information

Official study title

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

Acronym: COMPASS

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jun 26, 2013
Registry last updated
Apr 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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