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.
Verified October 2011 by St. Joseph's Healthcare Hamilton
Sponsor:
St. Joseph's Healthcare Hamilton
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: October 3, 2011
Last verified: October 2011
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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
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: | October 3, 2011 |
| 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 June 17, 2013