The fluid study protocol: a randomized controlled study on the effects of bioimpedance analysis and vitamin D on left ventricular mass in peritoneal dialysis patients

Abstract

Objectives: We will evaluate the effects of bioimpedance analysis-guided fluid management to reduce volume expansion, of vitamin D(3) supplementation, and of the combination of those techniques on decrease of left ventricular mass in peritoneal dialysis (PD) patients.

Design: This multicenter randomized controlled trial, with a 2 × 2 factorial design, will be conducted at PD clinics affiliated with 3 Canadian teaching hospitals. Consenting PD patients 18 years of age or older will be included. Patients will be excluded if they have contraindications to bioimpedance or magnetic resonance imaging, life or technique expectancy of less than 1 year, peritonitis within the preceding 3 months, or serum calcium above 2.55 mmol/L.

Intervention: The study will randomize 70 patients to bio-impedance-guided volume management or to usual care and to vitamin D(3) 50,000 U weekly for 8 doses, and then 10,000 U weekly or to matching placebo.

Main outcome measures: The primary outcome will be change in left ventricular mass at 1 year as determined by cardiac magnetic resonance imaging. The secondary outcome will be a composite endpoint of death, nonfatal cardiovascular event, and transfer to hemodialysis for dialysis inadequacy or ultrafiltration failure. Other outcome measures will include blood pressure, quality of life, 6-minute walk test, inflammatory and fibrotic markers and their association with peritoneal membrane transport properties, and residual renal function. Patients will be followed for clinical outcomes for up to 3 years.

Conclusions: This study will assess whether bioimpedance-directed volume management and vitamin D(3) supplementation can improve left ventricular mass in PD patients.

Trial registration: ClinicalTrials.gov NCT01045980.