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)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2012 by St. Joseph's Healthcare Hamilton
Sponsor:
Collaborator:
Population Health Research Institute
Information provided by (Responsible Party):
St. Joseph's Healthcare Hamilton
ClinicalTrials.gov Identifier:
NCT01045980
First received: January 8, 2010
Last updated: December 10, 2013
Last verified: June 2012
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Health-related quality of life (HRQOL) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Physical function as measured by 6 minute walk test [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Serum and peritoneal inflammatory and fibrotic markers: albumin, CRP, IL-6, TNF-a [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Peritoneal membrane transport properties,measured by PET [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Renal and peritoneal solute clearance, 24-hour urine output and ultrafiltration volume [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • left ventricular end-diastolic and systolic volumes, stroke volume and ejection fraction measure by MRI [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Fraility Score [ Time Frame: 1 year ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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 ClinicalTrials.gov identifier: NCT01045980

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

Locations
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
Investigators
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:
No publications provided by St. Joseph's Healthcare Hamilton

Additional 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
Study First Received: January 8, 2010
Last Updated: December 10, 2013
Health Authority: Canada: Health Canada

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
Ergocalciferols
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on July 24, 2014