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Effect of Bio-impedance Analysis and Vitamin D vs Usual Care on Left Ventricular Mass in Peritoneal Dialysis Patients: A Randomized Controlled Trial (FLUID Study) (FLUID)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2012 by St. Joseph's Healthcare Hamilton.
Recruitment status was:  Recruiting
Population Health Research Institute
Information provided by (Responsible Party):
St. Joseph's Healthcare Hamilton Identifier:
First received: January 8, 2010
Last updated: December 10, 2013
Last verified: June 2012
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.

Condition Intervention Phase
Peritoneal Dialysis
Drug: Bioimpedance and Vitamin D
Drug: Usual care and placebo
Drug: Usual care and Vitamin D
Device: Bioimpedance and Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by St. Joseph's Healthcare Hamilton:

Primary Outcome Measures:
  • Left ventricular mass measured by cardiac MRI [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • Combined outcome of death, non-fatal CV event (stroke, MI, amputation, CHF), and transfer to HD for inadequacy or ultrafiltration failure [ Time Frame: 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 [ Time Frame: 3 years ]
  • Health-related quality of life (HRQOL) [ Time Frame: 1 year ]
  • Physical function as measured by 6 minute walk test [ Time Frame: 1 year ]
  • Serum and peritoneal inflammatory and fibrotic markers: albumin, CRP, IL-6, TNF-a [ Time Frame: 1 year ]
  • Peritoneal membrane transport properties,measured by PET [ Time Frame: 3 years ]
  • Renal and peritoneal solute clearance, 24-hour urine output and ultrafiltration volume [ Time Frame: 3 years ]
  • left ventricular end-diastolic and systolic volumes, stroke volume and ejection fraction measure by MRI [ Time Frame: 1 year ]
  • Fraility Score [ Time Frame: 1 year ]

Estimated Enrollment: 70
Study Start Date: August 2010
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bioimpedance and Vitamin D 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.
Experimental: Usual care and Vitamin D
Vitamin D3
Drug: Usual care and Vitamin D
Usual care (not bioimpedance guided volume management) and Vitamin D
Experimental: Bioimpedance and Placebo Device: Bioimpedance and Placebo
Bioimpedance guided volume management and Placebo
Placebo Comparator: Usual Care and Placebo Drug: Usual care and placebo
Usual care (not bioimpedance guided volume management) and Placebo

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01045980

Contact: Dr. Azim S Gangji, MD MSc FRCPC 9055221155 ext 33261

Canada, Ontario
St. Joseph's Healthcare Hamilton Not yet recruiting
Hamilton, Ontario, Canada, L8N4A6
Contact: Azim Gangji, MD MSc FRCPC    (905)522-1155 ext 33261   
Contact: Scott Brimble, MD MSc FRCPC    (905)522-1155   
Principal Investigator: Azim Gangji, MD MSc FRCPC         
Principal Investigator: K S Brimble, MD MSc FRCPC         
Sub-Investigator: Catherine M Clase, MD MSc FRCPC         
Sub-Investigator: Peter Margetts, MD PhD FRCPC         
Sub-Investigator: Winnie S Su, MD FRCPC         
Population Health Research Institute - McMaster University Recruiting
Hamilton, Ontario, Canada
Sponsors and Collaborators
St. Joseph's Healthcare Hamilton
Population Health Research Institute
Principal Investigator: Azim S Gangji, MD MSc FRCPC St. Joseph's Healthcare Hamilton
Principal Investigator: K S Brimble, MD MSc FRCPC St. Joseph's Healthcare Hamilton
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: St. Joseph's Healthcare Hamilton Identifier: NCT01045980     History of Changes
Other Study ID Numbers: SJH-Renal-RCT-003
Study First Received: January 8, 2010
Last Updated: December 10, 2013

Keywords provided by St. Joseph's Healthcare Hamilton:
Peritoneal dialysis
Impedance, bioelectric
Hypertrophy, left ventricular
Fluid status
Volume overload
Congestive heart failure
Cardiovascular outcomes
Randomized controlled trial

Additional relevant MeSH terms:
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents processed this record on May 25, 2017