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Bioimpedance and Vitamin D for Peritoneal Dialysis (FLUID Trial)
Phase 2
Waitlist Available
Led By Azim S Gangji, MD MSc FRCPC
Research Sponsored by St. Joseph's Healthcare Hamilton
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥18 years
on peritoneal dialysis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
FLUID Trial 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.
FLUID Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowFLUID Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Left ventricular mass measured by cardiac MRI
Secondary outcome measures
Combined outcome of death, non-fatal CV event (stroke, MI, amputation, CHF), and transfer to HD for inadequacy or ultrafiltration failure
Fraility Score
Health-related quality of life (HRQOL)
+6 moreFLUID Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Usual care and Vitamin DExperimental Treatment1 Intervention
Vitamin D3
Group II: Bioimpedance and Vitamin DExperimental Treatment1 Intervention
Group III: Bioimpedance and PlaceboExperimental Treatment1 Intervention
Group IV: Usual Care and PlaceboPlacebo Group1 Intervention
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Who is running the clinical trial?
St. Joseph's Healthcare HamiltonLead Sponsor
196 Previous Clinical Trials
25,474 Total Patients Enrolled
Population Health Research InstituteOTHER
155 Previous Clinical Trials
679,842 Total Patients Enrolled
Azim S Gangji, MD MSc FRCPCPrincipal InvestigatorSt. Joseph's Healthcare Hamilton
Frequently Asked Questions
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