Disorders Associated With Peritoneal Dialysis
Conditions
Keywords
Peritoneal dialysis, Impedance, bioelectric, Hypertrophy, left ventricular, Fluid status, Volume overload, Congestive heart failure, Cardiovascular outcomes, Randomized controlled trial
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.
Interventions
DRUGBioimpedance 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.
DRUGUsual care and placebo
Usual care (not bioimpedance guided volume management) and Placebo
DRUGUsual care and Vitamin D
Usual care (not bioimpedance guided volume management) and Vitamin D
DEVICEBioimpedance and Placebo
Bioimpedance guided volume management and Placebo
Sponsors
Population Health Research Institute
St. Joseph's Healthcare Hamilton
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Left ventricular mass measured by cardiac MRI | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Combined outcome of death, non-fatal CV event (stroke, MI, amputation, CHF), and transfer to HD for inadequacy or ultrafiltration failure | 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 |
| Peritoneal membrane transport properties,measured by PET | 3 years |
Countries
Canada
Outcome results
None listed