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

April 16, 2018 updated by: Kook-Hwan Oh, Seoul National University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

108

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital Clinical Trial Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
delta GFR
Time Frame: baseline and 12th month
change of glomerular filtration rate from baseline to the 12th month
baseline and 12th month

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Fresenius Medical Care Korea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (ACTUAL)

May 1, 2016

Study Completion (ACTUAL)

July 1, 2016

Study Registration Dates

First Submitted

June 24, 2013

First Submitted That Met QC Criteria

June 25, 2013

First Posted (ESTIMATE)

June 26, 2013

Study Record Updates

Last Update Posted (ACTUAL)

April 18, 2018

Last Update Submitted That Met QC Criteria

April 16, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • COMPASS (CardioDx)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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