Actively Recruiting
Randomised Evaluation of Sodium Dialysate Levels on Vascular Events
Led by University of Sydney · Updated on 2025-04-04
50000
Participants Needed
264
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Sydney
Lead Sponsor
A
Australasian Kidney Trials Network
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the impact of two different default dialysate sodium concentrations on major cardiovascular events and death in adults receiving maintenance haemodialysis for end-stage kidney disease. This pragmatic, cluster-randomised, open-label Phase 4 study compares sodium levels of 137 mmoll and 140 mmoll in real-world dialysis settings across multiple sites globally. Dialysis sites will be randomly assigned to use either a default dialysate sodium concentration of 137 mmoll or 140 mmoll for at least 90 of dialysis sessions. Other aspects of patient care will follow standard local practices. Sites must consent to participate, and individual patients will provide waiver or opt-out consent. The study expects to enroll sites over 5 to 7 years, with each participant followed for approximately 2 to 5 years until the study endpoints are reached. Participants will receive dialysis at their assigned sites with the designated sodium concentration. Researchers will monitor the time to first occurrence of major cardiovascular events or death as the primary outcome. Secondary outcomes include other cardiovascular events and individual components of the composite outcomes. Data collection and patient monitoring will continue throughout the study period, estimated to last around five years per participant.
CONDITIONS
Brief Title
Randomised Evaluation of Sodium Dialysate Levels on Vascular Events
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Dialysis sites must mainly treat adults aged 18 years or older on maintenance haemodialysis
- Sites must have less than 15% withdrawal rate for social reasons within the first 2 years of dialysis in recent years
- Sites must have at least 10 dialysis recipients at randomisation
- Sites must already use a default dialysate sodium concentration for most dialysis sessions
- Sites must be self-contained units without regular patient rotation to other units
- Sites must accept randomisation to either dialysate sodium concentration
- Sites cannot be home dialysis training or support units, though combined sites with in-center patients may participate for in-center dialysis only
You will not qualify if you...
- Sites unable to comply with data collection methods
Research Team
G
Grace Balicki
E
Erika Dempsey
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