NCT01045980 - Assessment of Bioimpedance and Vitamin D and LV Mass in PD Patients (FLUID Study) | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

August 1, 2010

Primary Completion Date

May 15, 2016

Study Completion Date

November 30, 2016

Conditions

Disorders Associated With Peritoneal Dialysis

Interventions

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.

DRUG

Usual care and placebo

Usual care (not bioimpedance guided volume management) and Placebo

DRUG

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

Trial Locations (2)

L8N4A6

St. Joseph's Healthcare Hamilton, Hamilton

Unknown

Population Health Research Institute - McMaster University, Hamilton