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โ† Trials
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Randomised Evaluation of Sodium Dialysate Levels on Vascular Events

RecruitingPhase 4Ages 18 Years - anyAllUniversity of Sydney
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
The site inclusion criteria are: * Predominantly dialyses adults (โ‰ฅ18 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
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What it tests

  • Default dialysate sodium concentration of 137mmol/l
  • Default dialysate sodium concentration of 140mmol/l
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Where

264 sites
Royal Adelaide Hospital
Adelaide, Australia
Auburn Hospital
Auburn, Australia
Flinders Medical Centre
Bedford Park, Australia
Moorabbin Hospital
Bentleigh East, Australia
Sunshine Coast University Private Hospital
Birtinya, Australia
Princess Alexandra Hospital
Brisbane, Australia
Redlands Hospital
Brisbane, Australia
Bundaberg Hospital
Bundaberg, Australia

โ€ฆand 256 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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