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Assessment of Bioimpedance and Vitamin D and LV Mass in PD Patients (FLUID Study)

NCT01045980 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2025-05-18

No results posted yet for this study

Summary

The main purpose of this study is to compare the effects of using bio-impedance analysis to guide management of fluid status versus routine clinical care on heart structure. In addition, Vitamin D is being assessed to determine its effect on heart structure.

Conditions

  • Disorders Associated With Peritoneal Dialysis

Interventions

DRUG

Bioimpedance and Vitamin D

Intervention subjects will undergo BIA assessment monthly for 1 year, and then every 3 months until the end of the planned 3-year study. Protocolized interventions to achieve euvolemia will occur based on the BIA result and they include sodium restriction, addition of diuretics, use of icodextrin, and additional rational changes to the PD prescription.

DRUG

Usual care and placebo

Usual care (not bioimpedance guided volume management) and Placebo

DRUG

Usual care and Vitamin D

Usual care (not bioimpedance guided volume management) and Vitamin D

DEVICE

Bioimpedance and Placebo

Bioimpedance guided volume management and Placebo

Sponsors & Collaborators

  • Population Health Research Institute

    collaborator OTHER

  • St. Joseph's Healthcare Hamilton

    lead OTHER

Principal Investigators

  • Azim S Gangji, MD MSc FRCPC · St. Joseph's Healthcare Hamilton

  • K S Brimble, MD MSc FRCPC · St. Joseph's Healthcare Hamilton

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-01
Primary Completion
2016-05-15
Completion
2016-11-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01045980 on ClinicalTrials.gov