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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-01

Study Completion Date

2016-11-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Disorders Associated With Peritoneal Dialysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Bioimpedance and Vitamin D

Group Type EXPERIMENTAL

Bioimpedance and Vitamin D

Intervention Type 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 Vitamin D

Usual Care and Vitamin D3

Group Type EXPERIMENTAL

Usual care and Vitamin D

Intervention Type DRUG

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

Bioimpedance and Placebo

Group Type EXPERIMENTAL

Bioimpedance and Placebo

Intervention Type DEVICE

Bioimpedance guided volume management and Placebo

Usual Care and Placebo

Group Type PLACEBO_COMPARATOR

Usual care and placebo

Intervention Type DRUG

Usual care (not bioimpedance guided volume management) and Placebo

Interventions

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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.

Intervention Type DRUG

Usual care and placebo

Usual care (not bioimpedance guided volume management) and Placebo

Intervention Type DRUG

Usual care and Vitamin D

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

Intervention Type DRUG

Bioimpedance and Placebo

Bioimpedance guided volume management and Placebo

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No