Randomised Evaluation of Sodium Dialysate Levels on Vascular Events
End-stage Kidney DiseaseThis 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.
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Participation Requirements
-
Sex:
ALL -
Eligible Ages:
18 and up
Participation Criteria
The site inclusion criteria are:
* 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. \[Sites that include both in-center/satellite dialysis patients and home patients may participate but the study procedures and assessments will only be conducted in the incenter/satellite component of the site\].
The exclusion criteria are:
* Not able to comply with data collection methods
Study Location
Chatam-Kent Health Alliance
Chatam-Kent Health AllianceChatham, Ontario
Canada
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London Health Sciences Centre
London Health Sciences CentreLondon, Ontario
Canada
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Huron Perth Hospital Partnership
Huron Perth Hospital PartnershipStratford, Ontario
Canada
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Brantford General Hospital
Brantford General HospitalBrantford, Ontario
Canada
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Adam Linton Dialysis Unit - Victoria Hospital
Adam Linton Dialysis Unit - Victoria HospitalLondon, Ontario
Canada
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Bluewater Hospital
Bluewater HospitalSarnia, Ontario
Canada
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Hanover District Hospital
Hanover District HospitalHanover, Ontario
Canada
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Grey Bruce Health Services
Grey Bruce Health ServicesOwen Sound, Ontario
Canada
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Woodstock General Hospital
Woodstock General HospitalWoodstock, Ontario
Canada
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St Joseph's Healthcare
St Joseph's HealthcareHamilton, Ontario
Canada
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Westmount Kidney Care Centre
Westmount Kidney Care CentreLondon, Ontario
Canada
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Tillsonburg District Memorial Hospital
Tillsonburg District Memorial HospitalTillsonburg, Ontario
Canada
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- Study Sponsored By
- University of Sydney
- Participants Required
- More Information
- Study ID:
NCT02823821