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Recruiting Phase 4 NCT02823821

Randomised Evaluation of Sodium Dialysate Levels on Vascular Events

Trial Parameters

Condition End-Stage Kidney Disease
Sponsor University of Sydney
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 50,000
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2016-06
Completion 2026-12
Interventions
Default dialysate sodium concentration of 137mmol/lDefault dialysate sodium concentration of 140mmol/l

Brief 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 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 pr

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