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)

Peritoneal Dialysis Clinical Trial

— FLUID  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01045980
• Other study ID #: SJH-Renal-RCT-003
• Status: Recruiting
• Phase: Phase 2
• First received: January 8, 2010
• Last updated: December 10, 2013
• Start date: August 2010
• Est. completion date: August 2015

Study information

• Verified date: June 2012
• Source: St. Joseph's Healthcare Hamilton
• Contact: Dr. Azim S Gangji, MD MSc FRCPC
• Phone: 9055221155
• Email: gangji[@]mcmaster.ca
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: August 2015
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Peritoneal Dialysis

Intervention

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.
• Usual care and placebo
Usual care (not bioimpedance guided volume management) and Placebo
• 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

Locations

Country	Name	City	State
Canada	Population Health Research Institute - McMaster University	Hamilton	Ontario
Canada	St. Joseph's Healthcare Hamilton	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
St. Joseph's Healthcare Hamilton	Population Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Left ventricular mass measured by cardiac MRI		1 year	No
Secondary	Combined outcome of death, non-fatal CV event (stroke, MI, amputation, CHF), and transfer to HD for inadequacy or ultrafiltration failure		3 years	Yes
Secondary	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	Yes
Secondary	Health-related quality of life (HRQOL)		1 year	No
Secondary	Physical function as measured by 6 minute walk test		1 year	No
Secondary	Serum and peritoneal inflammatory and fibrotic markers: albumin, CRP, IL-6, TNF-a		1 year	No
Secondary	Peritoneal membrane transport properties,measured by PET		3 years	No
Secondary	Renal and peritoneal solute clearance, 24-hour urine output and ultrafiltration volume		3 years	No
Secondary	left ventricular end-diastolic and systolic volumes, stroke volume and ejection fraction measure by MRI		1 year	No
Secondary	Fraility Score		1 year	No

External Links

•   Hamilton Centre for Kidney Research