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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Seoul National University Hospital
Sponsor:
Collaborator:
Fresenius Medical Care Korea
Information provided by (Responsible Party):
Kook-Hwan Oh, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01887262
First received: June 24, 2013
Last updated: June 17, 2014
Last verified: June 2014
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Control Of Fluid Balance Guided by Body Composition Monitoring in Patients on PeritoneAl dialySiS (COMPASS) Trial

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • delta GFR [ Time Frame: baseline and 12th month ] [ Designated as safety issue: No ]
    change of glomerular filtration rate from baseline to the 12th month


Secondary Outcome Measures:
  • GFR [ Time Frame: at 12th month ] [ Designated as safety issue: No ]
    glomerular filtration rate measured by urine collection, calculated by the mean of creatinine and urea clearance

  • time to anuria [ Time Frame: over 12 months ] [ Designated as safety issue: No ]
    time to the anuric state (urine volume < 100cc/d)

  • echocardiographic parameters [ Time Frame: 12 months period ] [ Designated as safety issue: No ]
    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)

  • BP [ Time Frame: 12th month ] [ Designated as safety issue: No ]
    systolic, diastolic blood pressure, pulse pressure

  • cardiovascular event [ Time Frame: over 12 months ] [ Designated as safety issue: No ]
    fatal and nonfatal cardiovascular events - acute myocardial infarction (AMI), stroke, unstable angina, amputation, cardiovascular revascularization

  • BCM parameters [ Time Frame: baseline and 12th month ] [ Designated as safety issue: No ]
    parameters measured by body composition monitoring (BCM), such as overhydration(OH), extracellular water (ECW), extracellular-to-intracellular water ratio (ECW/ICW)


Estimated Enrollment: 138
Study Start Date: July 2013
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01887262

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

Locations
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
  More Information

Publications:
Responsible Party: Kook-Hwan Oh, Associate Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01887262     History of Changes
Other Study ID Numbers: COMPASS
Study First Received: June 24, 2013
Last Updated: June 17, 2014
Health Authority: Korea: Institutional Review Board

Keywords provided by Seoul National University Hospital:
fluid
edema

ClinicalTrials.gov processed this record on September 16, 2014