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

Phase 2

Completed

• Conditions: Disorders Associated With Peritoneal Dialysis
• Interventions: Drug: Bioimpedance and Vitamin D; Drug: Usual care and Vitamin D; Device: Bioimpedance and Placebo; Drug: Usual care and placebo

• Registration Number: NCT01045980
• Lead Sponsor: St. Joseph's Healthcare Hamilton

Brief 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.

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 Timeline

• Study First Submitted: 2010-01-08
• Study First Submitted QC: 2010-01-08
• Study First Posted: 2010-01-11
• Study Start: 2010-08-01
• Primary Completion: 2016-05-15
• Study Completion: 2016-11-30
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Bioimpedance and Vitamin D	Bioimpedance and Vitamin D	Bioimpedance and Vitamin D
Usual care and Vitamin D	Usual care and Vitamin D	Usual Care and Vitamin D3
Bioimpedance and Placebo	Bioimpedance and Placebo	Bioimpedance and Placebo
Usual Care and Placebo	Usual care and placebo	Usual Care and Placebo

Primary Outcome Measures

Name	Time	Method
Left ventricular mass measured by cardiac MRI	1 year

Secondary Outcome Measures

Name	Time	Method
Combined outcome of death, non-fatal CV event (stroke, MI, amputation, CHF), and transfer to HD for inadequacy or ultrafiltration failure	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	3 years
Health-related quality of life (HRQOL)	1 year
Physical function as measured by 6 minute walk test	1 year
Serum and peritoneal inflammatory and fibrotic markers: albumin, CRP, IL-6, TNF-a	1 year
Peritoneal membrane transport properties,measured by PET	3 years
Renal and peritoneal solute clearance, 24-hour urine output and ultrafiltration volume	3 years
left ventricular end-diastolic and systolic volumes, stroke volume and ejection fraction measure by MRI	1 year
Fraility Score	1 year

Trial Locations

Locations (2)

St. Joseph's Healthcare Hamilton; 🇨🇦 Hamilton, Ontario, Canada

Population Health Research Institute - McMaster University; 🇨🇦 Hamilton, Ontario, Canada