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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)

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ClinicalTrials.gov Identifier: NCT01045980
Recruitment Status : Unknown
Verified June 2012 by St. Joseph's Healthcare Hamilton.
Recruitment status was:  Recruiting
First Posted : January 11, 2010
Last Update Posted : December 11, 2013
Population Health Research Institute
Information provided by (Responsible Party):
St. Joseph's Healthcare Hamilton

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.

Condition or disease Intervention/treatment 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

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (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
Study Start Date : August 2010
Estimated Primary Completion Date : August 2014
Estimated Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D
U.S. FDA Resources

Arm Intervention/treatment
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

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

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Health-related quality of life (HRQOL) [ Time Frame: 1 year ]
  4. Physical function as measured by 6 minute walk test [ Time Frame: 1 year ]
  5. Serum and peritoneal inflammatory and fibrotic markers: albumin, CRP, IL-6, TNF-a [ Time Frame: 1 year ]
  6. Peritoneal membrane transport properties,measured by PET [ Time Frame: 3 years ]
  7. Renal and peritoneal solute clearance, 24-hour urine output and ultrafiltration volume [ Time Frame: 3 years ]
  8. left ventricular end-diastolic and systolic volumes, stroke volume and ejection fraction measure by MRI [ Time Frame: 1 year ]
  9. Fraility Score [ Time Frame: 1 year ]

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01045980

Contact: Dr. Azim S Gangji, MD MSc FRCPC 9055221155 ext 33261 gangji@mcmaster.ca

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    gangji@mcmaster.ca   
Contact: Scott Brimble, MD MSc FRCPC    (905)522-1155    brimbles@mcmaster.ca   
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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: St. Joseph's Healthcare Hamilton
ClinicalTrials.gov Identifier: NCT01045980     History of Changes
Other Study ID Numbers: SJH-Renal-RCT-003
First Posted: January 11, 2010    Key Record Dates
Last Update Posted: December 11, 2013
Last Verified: June 2012

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