CompletedPhase 2

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

Canada74 participantsStarted 2010-08-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Left ventricular mass measured by cardiac MRI

Timeframe: 1 year

Trial details

NCT IDNCT01045980

SponsorSt. Joseph's Healthcare Hamilton

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-05-15

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