Clinical trial NCT01045980: Assessment of Bioimpedance and Vitamin D and LV Mass in PD Patients (FLUID Study)
Official title: The Effect of Bio-impedance Analysis and Vitamin D Versus Usual Care on Left Ventricular Mass in Peritoneal Dialysis Patients: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Disorders Associated With Peritoneal Dialysis
Keywords: Peritoneal dialysis
Impedance, bioelectric
Hypertrophy, left ventricular
Fluid status
Volume overload
Congestive heart failure
Cardiovascular outcomes
Randomized controlled trial
Lead sponsor: St. Joseph's Healthcare Hamilton
Sponsor class: OTHER
Collaborators: name: Population Health Research Institute
First posted: 2010-01-11
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Left ventricular mass measured by cardiac MRI
timeFrame: 1 year
Secondary outcomes:
measure: Combined outcome of death, non-fatal CV event (stroke, MI, amputation, CHF), and transfer to HD for inadequacy or ultrafiltration failure
timeFrame: 3 years
measure: 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
timeFrame: 3 years
measure: Health-related quality of life (HRQOL)
timeFrame: 1 year
measure: Physical function as measured by 6 minute walk test
timeFrame: 1 year
measure: Serum and peritoneal inflammatory and fibrotic markers: albumin, CRP, IL-6, TNF-a
timeFrame: 1 year
measure: Peritoneal membrane transport properties,measured by PET
timeFrame: 3 years
measure: Renal and peritoneal solute clearance, 24-hour urine output and ultrafiltration volume
timeFrame: 3 years
measure: left ventricular end-diastolic and systolic volumes, stroke volume and ejection fraction measure by MRI
timeFrame: 1 year
measure: Fraility Score
timeFrame: 1 year
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton
state: Ontario
city: Hamilton
country: Canada
facility: Population Health Research Institute - McMaster University
state: Ontario
Study officials:
affiliation: St. Joseph's Healthcare Hamilton
name: Azim S Gangji, MD MSc FRCPC
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Joseph's Healthcare Hamilton
name: K S Brimble, MD MSc FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brimble KS, Ganame J, Margetts P, Jain A, Perl J, Walsh M, Bosch J, Yusuf S, Beshay S, Su W, Zimmerman D, Lee SF, Gangji AS. Impact of Bioelectrical Impedance-Guided Fluid Management and Vitamin D Supplementation on Left Ventricular Mass in Patients Receiving Peritoneal Dialysis: A Randomized Controlled Trial. Am J Kidney Dis. 2022 Jun;79(6):820-831. doi: 10.1053/j.ajkd.2021.08.022. Epub 2021 Oct 14.
citation: Su WS, Gangji AS, Margetts PM, Bosch J, Yusuf S, Clase CM, Ganame J, Noseworthy M, Lonn E, Jain AK, McCormick B, Brimble KS. 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. Perit Dial Int. 2011 Sep-Oct;31(5):529-36. doi: 10.3747/pdi.2010.00232. Epub 2011 May 31.