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

NCT01045980 | Completed Phase 2 DMC

• 1 other identifier: SJH-Renal-RCT-003
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (1)

• Left ventricular mass measured by cardiac MRI

  1 year

Secondary Outcomes (9)

• Combined outcome of death, non-fatal CV event (stroke, MI, amputation, CHF), and transfer to HD for inadequacy or ultrafiltration failure

  3 years

• 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

  3 years

• Health-related quality of life (HRQOL)

  1 year

• Physical function as measured by 6 minute walk test

  1 year

• Serum and peritoneal inflammatory and fibrotic markers: albumin, CRP, IL-6, TNF-a

  1 year

Study Arms (4)

Bioimpedance and Vitamin D

EXPERIMENTAL

Bioimpedance and Vitamin D

Drug: Bioimpedance and Vitamin D

Usual care and Vitamin D

EXPERIMENTAL

Usual Care and Vitamin D3

Drug: Usual care and Vitamin D

Bioimpedance and Placebo

EXPERIMENTAL

Bioimpedance and Placebo

Device: Bioimpedance and Placebo

Usual Care and Placebo

PLACEBO COMPARATOR

Usual Care and Placebo

Drug: Usual care and placebo

Interventions

Bioimpedance and Vitamin D DRUG

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.

Bioimpedance and Vitamin D

Usual care and placebo DRUG

Usual care (not bioimpedance guided volume management) and Placebo

Usual Care and Placebo

Usual care and Vitamin D DRUG

Usual care (not bioimpedance guided volume management) and Vitamin D

Usual care and Vitamin D

Bioimpedance and Placebo DEVICE

Bioimpedance guided volume management and Placebo

Bioimpedance and Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• on peritoneal dialysis

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Joseph's Healthcare Hamilton: lead
• Population Health Research Institute: collaborator

Study Sites (2)

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N4A6, Canada

Location

Population Health Research Institute - McMaster University

Hamilton, Ontario, Canada

Location

Related Publications (2)

• 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.

  PMID: 34656640 DERIVED

• 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.

  PMID: 21632446 DERIVED

Related Links

• Hamilton Centre for Kidney Research

MeSH Terms

Conditions

Hypertrophy, Left Ventricular; Edema; Heart Failure

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Cardiomegaly; Heart Diseases; Cardiovascular Diseases; Hypertrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Azim S Gangji, MD MSc FRCPC

  St. Joseph's Healthcare Hamilton

  PRINCIPAL INVESTIGATOR

• K S Brimble, MD MSc FRCPC

  St. Joseph's Healthcare Hamilton

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2010
• First Posted: January 11, 2010
• Study Start: August 1, 2010
• Primary Completion: May 15, 2016
• Study Completion: November 30, 2016
• Last Updated: May 18, 2025

Record last verified: 2025-05

Locations

CA (2)