Randomised Evaluation of Sodium Dialysate Levels on Vascular Events (RESOLVE)
Actively Recruiting
About This Study
The RESOLVE trial is a pragmatic, cluster-randomized, open-label study evaluating the comparative effectiveness of two default dialysate sodium concentrations in patients with ESKD receiving maintenance hemodialysis. Dialysis centers are randomized 1:1 to a default dialysate sodium of either 137 mmol/L or 140 mmol/L, with the default concentration applied to at least 90% of sessions at each site. The primary objective is to assess the impact of these concentrations on major cardiovascular events and all-cause mortality under real-world clinical conditions. All other aspects of care follow standard local practices, and outcomes are analyzed at the individual patient level.
Who Can Participate?
✓ Inclusion 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