NCT01887262

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 24, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 26, 2013

Completed
5 days until next milestone

Study Start

First participant enrolled

July 1, 2013

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

April 18, 2018

Status Verified

April 1, 2018

Enrollment Period

2.8 years

First QC Date

June 24, 2013

Last Update Submit

April 16, 2018

Conditions

Peritoneal Dialysis, Continuous Ambulatory

Keywords

fluidedema

Outcome Measures

Primary Outcomes (1)

  • delta GFR

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

    baseline and 12th month

Secondary Outcomes (6)

  • GFR

    at 12th month

  • time to anuria

    over 12 months

  • echocardiographic parameters

    12 months period

  • BP

    12th month

  • cardiovascular event

    over 12 months

  • +1 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

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

Interventions

BCM-guided fluid managementDEVICE
Intervention
Fluid management based on the clinical information alonePROCEDURE
Control

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age bwten 20 and 75
  • peritoneal dialysis \> 4 weeks duration
  • written consent
  • daily urine output \> 500 ml

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital Clinical Trial Center

Seoul, 110-744, South Korea

Location

Related Publications (2)

  • Van Biesen W, Williams JD, Covic AC, Fan S, Claes K, Lichodziejewska-Niemierko M, Verger C, Steiger J, Schoder V, Wabel P, Gauly A, Himmele R; EuroBCM Study Group. Fluid status in peritoneal dialysis patients: the European Body Composition Monitoring (EuroBCM) study cohort. PLoS One. 2011 Feb 24;6(2):e17148. doi: 10.1371/journal.pone.0017148.

    PMID: 21390320BACKGROUND

  • Baek SH, Oh KH, Kim S, Kim DK, Joo KW, Oh YK, Han BG, Chang JH, Chung W, Kim YS, Na KY. Control of fluid balance guided by body composition monitoring in patients on peritoneal dialysis (COMPASS): study protocol for a randomized controlled trial. Trials. 2014 Nov 6;15:432. doi: 10.1186/1745-6215-15-432.

    PMID: 25376940DERIVED

MeSH Terms

Conditions

Edema

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 24, 2013

First Posted

June 26, 2013

Study Start

July 1, 2013

Primary Completion

May 1, 2016

Study Completion

July 1, 2016

Last Updated

April 18, 2018

Record last verified: 2018-04

Locations

KR(1)