Randomised Evaluation of SOdium dialysate Levels on Vascular Events: A cluster clinical study
A pragmatic, cluster-randomised study designed to evaluate the effectiveness of dialysis units adopting one or two default sodium concentrations.
Principal Investigators: Professor Meg Jardine
Clinical Research Associate: Peta-Anne Paul-Brent
Trial Number: AKTN 15.02
Trial Registration Number: NCT02823821
Population: Adults (≥18 years old) receiving maintenance haemodialysis
Intervention: Default unit dialysate sodium of 137 mmol/l; Default unit dialysate sodium of 140 mmol/l.
Follow-up: 5 years
Primary outcome: Composite of major cardiovascular events (hospitalised myocardial infarction, hospitalised stroke) and all-cause mortality
Status: Recruitment open
Recruitment: participants across Australia and New Zealand.
Director of the CTC and the CTC’s Kidney Health Research Director
The RESOLVE study is an international trial led from Australia, haemodialysis units in multiple 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). Australian NHMRC project funding has been granted. International collaboration is led by the NHMRC Clinical Trials Centre, University of Sydney https://www.ctc.usyd.edu.au/, and Australian collaboration is led by the Australasian Kidney Trials Network https://aktn.org.au/.
The study will involve a staged roll-out at sites around the world.
The University of Sydney is the Global Sponsor and the Australasian Kidney Trials Network (AKTN) at the University of Queensland is the Local Sponsor. This project is being conducted in multiple countries and is due to complete in 2024. The study was designed in partnership with ANZDATA. For the study registration see here [https://clinicaltrials.gov/ct2/show/NCT02823821] and for more information contact email@example.com.
To establish whether for patients receiving maintenance haemodialysis, treatment in a centre with a default dialysate sodium (DNa+) of 137mmol/l reduces major cardiovascular events and death compared with treatment in a centre with a default DNa+ of 140mmol/l.
Participating sites must satisfy all of the following:
- 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
- Is a self-contained unit
- Willing to accept randomisation to either intervention or control
- Is not a home dialysis training or support unit.
Participating sites must NOT satisfy any of the following:
- Not able to comply with data collection methods
Trial Coordinator, ANZDATA: Kylie Hurst, General Manager
Phone: on (08) 8128 4758