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

January 8, 2010
December 10, 2013
August 2010
August 2014   (final data collection date for primary outcome measure)
Left ventricular mass measured by cardiac MRI [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01045980 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
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)
The Effect of Bio-impedance Analysis and Vitamin D Versus Usual Care on Left Ventricular Mass in Peritoneal Dialysis Patients: a Randomized Controlled Trial

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Peritoneal Dialysis
  • 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.
  • Drug: Usual care and placebo
    Usual care (not bioimpedance guided volume management) and Placebo
  • Drug: Usual care and Vitamin D
    Usual care (not bioimpedance guided volume management) and Vitamin D
  • Device: Bioimpedance and Placebo
    Bioimpedance guided volume management and Placebo
  • Experimental: Bioimpedance and Vitamin D
    Intervention: Drug: Bioimpedance and Vitamin D
  • Experimental: Usual care and Vitamin D
    Vitamin D3
    Intervention: Drug: Usual care and Vitamin D
  • Experimental: Bioimpedance and Placebo
    Intervention: Device: Bioimpedance and Placebo
  • Placebo Comparator: Usual Care and Placebo
    Intervention: Drug: Usual care and placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
70
August 2015
August 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Dr. Azim S Gangji, MD MSc FRCPC 9055221155 ext 33261 gangji@mcmaster.ca
Canada
 
NCT01045980
SJH-Renal-RCT-003
Yes
St. Joseph's Healthcare Hamilton
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
St. Joseph's Healthcare Hamilton
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP