Effect of Bio-impedance Analysis and Vitamin D vs Usual Care on Left Ventricular Mass in Peritoneal Dialysis Patients: A Randomized Controlled Trial (FLUID Study)

Study Overview
=================
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.

Official 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

Conditions
-----------------
Peritoneal Dialysis

Intervention / Treatment
-----------------
* Drug: Bioimpedance and Vitamin D
* Drug: Usual care and placebo
* Drug: Usual care and Vitamin D
* Device: Bioimpedance and Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left ventricular mass measured by cardiac MRI |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Peritoneal dialysis, Impedance, bioelectric, Hypertrophy, left ventricular, Fluid status, Volume overload, Congestive heart failure, Cardiovascular outcomes, Randomized controlled trial