NCT01045980

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: St. Joseph's Healthcare Hamilton · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Disorders Associated With Peritoneal Dialysis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2010-08-01
• Primary completion: 2016-05-15
• Completion: 2016-11-30
• First posted: 2010-01-11
• Last updated: 2025-05-18

Locations

2 sites across 1 country: Canada