Randomised Evaluation of Sodium Dialysate Levels on Vascular Events
Recruiting
Phase 4
Interventional Study
End-Stage Kidney Disease
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Health Services Research
- Participants needed
- 50,000 (estimated)
- Sponsor
- University of Sydney · Other
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About This Trial
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.
Trial Locations
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Eligibility 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 increa…
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