RecruitingPhase 4NCT02823821
Randomised Evaluation of Sodium Dialysate Levels on Vascular Events
Sponsor
University of Sydney
Enrollment
50,000 participants
Start Date
Jun 1, 2016
Study Type
INTERVENTIONAL
Conditions
Summary
This global study will assess the effect of randomising dialysis sites to one of two default dialysate sodium concentrations in current practice, 140mmol/l and 137mmol/l, on major cardiovascular events and death in patients receiving maintenance haemodialysis.
Eligibility
Min Age: 18 Years
Inclusion Criteria7
- Predominantly dialyses adults (≥18 years old) receiving maintenance haemodialysis
- Rates of withdrawal within the first two years of commencing dialysis for social reasons have been less than 15% for the 2 years prior to recruitment and are not expected to increase above 15%
- Has a minimum of 10 dialysis recipients at time of randomisation
- Utilises a default dialysate sodium concentration at the time of recruitment (a substantial majority of dialysis sessions are conducted with the default dialysate sodium concentration)
- Is a self-contained unit (i.e. unit patients do not regularly rotate through another unit. Brief trips by patients to a parent or other unit do not exclude a site)
- Willing to accept randomisation to either intervention (as determined by nominated Director of Unit)
- Is not a home dialysis training or support unit. \[Sites that include both in-center/satellite dialysis patients and home patients may participate but the study procedures and assessments will only be conducted in the incenter/satellite component of the site\].
Exclusion Criteria1
- Not able to comply with data collection methods
Interventions
OTHERDefault dialysate sodium concentration of 137mmol/l
Default defined here as use of allocated dialysate sodium concentration for at least 90% of delivered dialysis sessions.
OTHERDefault dialysate sodium concentration of 140mmol/l
Default defined here as use of allocated dialysate sodium concentration for at least 90% of delivered dialysis sessions.
Locations(264)
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NCT02823821
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