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Completed

NCT Number: NCT01045980

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

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.

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Key information

Conditions

Disorders Associated With Peritoneal Dialysis Cardiomegaly Cardiovascular Diseases Edema Heart Diseases Heart Failure Hypertrophy Hypertrophy, Left Ventricular Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Population Health Research Institute - McMaster University, Hamilton, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bioimpedance and Vitamin D

Drug

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.

Usual care and placebo

Drug

Usual care (not bioimpedance guided volume management) and Placebo

Usual care and Vitamin D

Drug

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

Bioimpedance and Placebo

Device

Bioimpedance guided volume management and Placebo

Primary outcomes

  1. Left ventricular mass measured by cardiac MRI

    Time frame: 1 year

Secondary outcomes

  1. 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

  2. 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. Health-related quality of life (HRQOL)

    Time frame: 1 year

  4. Physical function as measured by 6 minute walk test

    Time frame: 1 year

  5. Serum and peritoneal inflammatory and fibrotic markers: albumin, CRP, IL-6, TNF-a

    Time frame: 1 year

  6. Peritoneal membrane transport properties,measured by PET

    Time frame: 3 years

  7. Renal and peritoneal solute clearance, 24-hour urine output and ultrafiltration volume

    Time frame: 3 years

  8. left ventricular end-diastolic and systolic volumes, stroke volume and ejection fraction measure by MRI

    Time frame: 1 year

  9. Fraility Score

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

St. Joseph's Healthcare Hamilton

Other

Collaborators

  • Population Health Research Institute

Registry information

Official study title

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

Acronym: FLUID

Important dates

Study start
2010
Primary completion
2016
Study completion
2016
First posted
Jan 11, 2010
Registry last updated
May 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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