Compares two dialysis salt levels in people with kidney failure
Tests two dialysis sodium levels in adults receiving maintenance haemodialysis for kidney failure.
Plain-language title generated from the registry record
Registry title: Randomised Evaluation of Sodium Dialysate Levels on Vascular Events
Key facts
- Where
- Albstadt, Berlin, Bochum, Darmstadt, Elsenfeld, Hechingen, Homburg, Langen, Lichtenfels, Mainz, Munich, Öhringen, Schweinfurt, Siegburg, Unna, and Villingen-Schwenningen, GermanySee the 16 sites
- Phase
- Phase 4
Where in Germany
- Nephrologisches Zentrum AlbstadtAlbstadt, GermanyTaking people
- Praxis für Nierenkrankheiten Berlin HellersdorfBerlin, GermanyTaking people
- Dialyse am Kortumpark BochumBochum, GermanyTaking people
- Dialysezentrum DarmstadtDarmstadt, GermanyTaking people
- Dialysezentrum ElsenfeldElsenfeld, GermanyTaking people
- Nephrologisches Zentrum HechingenHechingen, GermanyTaking people
- Arbeitsgemeinschaft Heimdialyse Saar e.V.Homburg, GermanyTaking people
- Dialysezentrum LangenLangen, GermanyTaking people
- KfH Nierenzentrum LichtenfelsLichtenfels, GermanyTaking people
- Universitätsmedizin Mainz, Dialysestation 605-5EMainz, GermanyTaking people
- KfH Nierenzentrum München SchwabingMunich, GermanyTaking people
- UBAG ÖhringenÖhringen, GermanyTaking people
- Dialysezentrum SchweinfurtSchweinfurt, GermanyTaking people
- Dialysezentrum SiegburgSiegburg, GermanyTaking people
- Nephrologie - Dialyse - Christliches Klinikum UnnaUnna, GermanyTaking people
- Nephrologisches Zentrum Villingen-Schwenningen -TuttlingenVillingen-Schwenningen, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Sydney
- Trial code
- NCT02823821
- Record updated
- 4 April 2025
- Original description
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.Read full original descriptionShow less
Randomised Evaluation of Sodium Dialysate Levels on Vascular Events
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.
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.