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

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ClinicalTrials.gov Identifier: NCT01887262
Recruitment Status : Unknown
Verified June 2014 by Kook-Hwan Oh, Seoul National University Hospital.
Recruitment status was:  Recruiting
First Posted : June 26, 2013
Last Update Posted : June 18, 2014
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Peritoneal Dialysis, Continuous Ambulatory Device: BCM-guided fluid management Procedure: Fluid management based on the clinical information alone Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 138 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Control Of Fluid Balance Guided by Body Composition Monitoring in Patients on PeritoneAl dialySiS (COMPASS) Trial
Study Start Date : July 2013
Estimated Primary Completion Date : May 2015
Estimated Study Completion Date : July 2015
Arms and Interventions

Arm Intervention/treatment
Experimental: Intervention
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.
Device: BCM-guided fluid management
Active Comparator: Control
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.
Procedure: Fluid management based on the clinical information alone

Outcome Measures

Primary Outcome Measures :
  1. delta GFR [ Time Frame: baseline and 12th month ]
    change of glomerular filtration rate from baseline to the 12th month

Secondary Outcome Measures :
  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)

Eligibility Criteria

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01887262

Contact: Kook-Hwan Oh, M.D, Ph.D 82 2 2072 0776
Contact: Ki-Young Na, M.D, Ph.D 82 10 9267 4315

Korea, Republic of
Seoul National University Hospital Clinical Trial Center Recruiting
Seoul, Korea, Republic of, 110-744
Contact: SuJin Cho    82 2 2072 0694    snuhirb@gmail.com   
Principal Investigator: Kook-Hwan Oh, MD PhD         
Sponsors and Collaborators
Seoul National University Hospital
Fresenius Medical Care Korea