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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
74
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 (not bioimpedance guided volume management) and Placebo
Usual care (not bioimpedance guided volume management) and Vitamin D
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada
Population Health Research Institute - McMaster University
Hamilton, Ontario, Canada
Left ventricular mass measured by cardiac MRI
Time frame: 1 year
Combined outcome of death, non-fatal CV event (stroke, MI, amputation, CHF), and transfer to HD for inadequacy or ultrafiltration failure
Time frame: 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
Time frame: 3 years
Health-related quality of life (HRQOL)
Time frame: 1 year
Physical function as measured by 6 minute walk test
Time frame: 1 year
Serum and peritoneal inflammatory and fibrotic markers: albumin, CRP, IL-6, TNF-a
Time frame: 1 year
Peritoneal membrane transport properties,measured by PET
Time frame: 3 years
Renal and peritoneal solute clearance, 24-hour urine output and ultrafiltration volume
Time frame: 3 years
left ventricular end-diastolic and systolic volumes, stroke volume and ejection fraction measure by MRI
Time frame: 1 year
Fraility Score
Time frame: 1 year
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Bioimpedance guided volume management and Placebo