Assessment of Bioimpedance and Vitamin D and LV Mass in PD Patients (FLUID Study)

St. Joseph's Healthcare Hamilton

Status and phase: Completed; Phase 2

Conditions: Disorders Associated With Peritoneal Dialysis

Treatments: Drug: Bioimpedance and Vitamin D; Device: Bioimpedance and Placebo; Drug: Usual care and Vitamin D; Drug: Usual care and placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01045980

SJH-Renal-RCT-003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 74 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

---

74 participants in 4 patient groups, including a placebo group

Bioimpedance and Vitamin D

Experimental group

Description:

Bioimpedance and Vitamin D

Treatment:

Drug: Bioimpedance and Vitamin D

Usual care and Vitamin D

Experimental group

Description:

Usual Care and Vitamin D3

Treatment:

Drug: Usual care and Vitamin D

Bioimpedance and Placebo

Experimental group

Description:

Bioimpedance and Placebo

Treatment:

Device: Bioimpedance and Placebo

Usual Care and Placebo

Placebo Comparator group

Description:

Usual Care and Placebo

Treatment:

Drug: Usual care and placebo