Randomised Evaluation of SOdium dialysate Levels on Vascular Events: A cluster clinical study
Principal Investigators: Professor Meg Jardine
Clinical Project Manager: Peta-Anne Paul-Brent
Clinical Research Associate: Thai Ha Pham
Population: Dialyse adults (≥18 years old) receiving maintenance dialysis
Primary outcome: This global study will establish whether treatment with a default dialysate sodium concentration of 137 mmol/l compared with 140mmol/l reduces major cardiovascular events and death in adult patients receiving haemodialysis in centres employing a default dialysate sodium.
Status: Recruitment open
Target Recruitment: 308 clusters globally (Aiming for 414 total)
Trail Summary
In the RESOLVE study, haemodialysis units Australia, New Zealand, China, India and other interested countries will be cluster randomised by unit to receive one of two sodium dialysate levels (137mmol/L or 140mmol/L). Major cardiovascular events (i.e. myocardial infarction, hospitalised heart failure, stroke and all-cause death) are being reported pragmatically within existing data collection systems where available (i.e. ANZDATA Registry in Australia and New Zealand). New Zealand HRC and Australian NHMRC project funding have been granted. International collaboration is led by the NHMRC CTC, Sydney and Australian collaboration is led by the Australasian Kidney Trials Network.