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Randomised Evaluation of Sodium Dialysate Levels on Vascular Events

End-stage Kidney Disease

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.

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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 Alliance
Chatham, Ontario
Canada

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London Health Sciences Centre
London Health Sciences Centre
London, Ontario
Canada

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Huron Perth Hospital Partnership
Huron Perth Hospital Partnership
Stratford, Ontario
Canada

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Brantford General Hospital
Brantford General Hospital
Brantford, Ontario
Canada

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Adam Linton Dialysis Unit - Victoria Hospital
Adam Linton Dialysis Unit - Victoria Hospital
London, Ontario
Canada

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Bluewater Hospital
Bluewater Hospital
Sarnia, Ontario
Canada

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Hanover District Hospital
Hanover District Hospital
Hanover, Ontario
Canada

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Grey Bruce Health Services
Grey Bruce Health Services
Owen Sound, Ontario
Canada

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Woodstock General Hospital
Woodstock General Hospital
Woodstock, Ontario
Canada

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St Joseph's Healthcare
St Joseph's Healthcare
Hamilton, Ontario
Canada

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Westmount Kidney Care Centre
Westmount Kidney Care Centre
London, Ontario
Canada

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Tillsonburg District Memorial Hospital
Tillsonburg District Memorial Hospital
Tillsonburg, Ontario
Canada

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Study Sponsored By
University of Sydney
Participants Required
More Information
Study ID: NCT02823821