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

May 13, 2025 updated by: St. Joseph's Healthcare Hamilton

The Effect of Bio-impedance Analysis and Vitamin D Versus Usual Care on Left Ventricular Mass in Peritoneal Dialysis Patients: a Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients on peritoneal dialysis are frequently hypervolemic which is associated with deleterious changes in left ventricular (LV) architecture including increased LV mass. In dialysis patients, increased LV mass is associated with death. Recent randomized trials have demonstrated that increasing small solute clearance is not associated with improved outcomes - hence an increased interest in the management of volume control in ESRD patients. Bioimpedance analysis is inexpensive, safe and easy to use and appears to be more useful than other techniques to assess volume status in dialysis patients. In addition, dialysis patients are vitamin D deficient and this is also associated with an increased LV mass and its inherent complications.

This study will evaluate the use of bioimpedance analysis versus usual care to assess and manage volume status and the use of vitamin D versus placebo in peritoneal dialysis patients and its effect on LV mass as measured by cardiac MRI.

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Phase 2

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

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8N4A6
        • St. Joseph's Healthcare Hamilton
      • Hamilton, Ontario, Canada
        • Population Health Research Institute - McMaster University

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥18 years
  • on peritoneal dialysis

Exclusion Criteria:

  • Contraindication to MRI including presence of a pacemaker, defibrillator, ferromagnetic cerebral aneurysm clips, cochlear implants or eye prosthesis, neurostimulators, shrapnel in vital locations, surgery within 6 weeks, severe claustrophobia and severe obesity
  • Previous amputation
  • Life or technique expectancy < 1 year
  • Pregnancy
  • Peritonitis in previous 3 months
  • Currently using more than one extraneal bag per 24-hours
  • Known icodextrin allergy
  • Currently using non-Baxter PD solutions
  • Inability to provide consent
  • Allergy to cholecalciferol
  • Serum Calcium > 2.55 mmol/L

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bioimpedance and Vitamin D
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.
Experimental: Usual care and Vitamin D
Usual Care and Vitamin D3
Drug: Usual care and Vitamin D
Usual care (not bioimpedance guided volume management) and Vitamin D
Experimental: Bioimpedance and Placebo
Device: Bioimpedance and Placebo
Bioimpedance guided volume management and Placebo
Placebo Comparator: Usual Care and Placebo
Drug: Usual care and placebo
Usual care (not bioimpedance guided volume management) and Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Left ventricular mass measured by cardiac MRI
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Combined outcome of death, non-fatal CV event (stroke, MI, amputation, CHF), and transfer to HD for inadequacy or ultrafiltration failure
Time Frame: 3 years
3 years
Volume measures: bio-impedance (RXc graph, vector length, impedance ratio, phase angle, ECW:TBW ratio), weight, N-BNP, mean and pulse arterial pressure, number of anti-hypertensive agents
Time Frame: 3 years
3 years
Health-related quality of life (HRQOL)
Time Frame: 1 year
1 year
Physical function as measured by 6 minute walk test
Time Frame: 1 year
1 year
Serum and peritoneal inflammatory and fibrotic markers: albumin, CRP, IL-6, TNF-a
Time Frame: 1 year
1 year
Peritoneal membrane transport properties,measured by PET
Time Frame: 3 years
3 years
Renal and peritoneal solute clearance, 24-hour urine output and ultrafiltration volume
Time Frame: 3 years
3 years
left ventricular end-diastolic and systolic volumes, stroke volume and ejection fraction measure by MRI
Time Frame: 1 year
1 year
Fraility Score
Time Frame: 1 year
1 year

Collaborators and Investigators

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

Sponsor

St. Joseph's Healthcare Hamilton

Collaborators

Population Health Research Institute

Investigators

  • Principal Investigator: Azim S Gangji, MD MSc FRCPC, St. Joseph's Healthcare Hamilton
  • Principal Investigator: K S Brimble, MD MSc FRCPC, St. Joseph's Healthcare Hamilton

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

Helpful Links

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 (Actual)

August 1, 2010

Primary Completion (Actual)

May 15, 2016

Study Completion (Actual)

November 30, 2016

Study Registration Dates

First Submitted

January 8, 2010

First Submitted That Met QC Criteria

January 8, 2010

First Posted (Estimated)

January 11, 2010

Study Record Updates

Last Update Posted (Actual)

May 18, 2025

Last Update Submitted That Met QC Criteria

May 13, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SJH-Renal-RCT-003

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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