Status:
RECRUITING
Randomised Evaluation of Sodium Dialysate Levels on Vascular Events
Lead Sponsor:
University of Sydney
Collaborating Sponsors:
Australasian Kidney Trials Network
Australia & New Zealand Dialysis & Transplant Registry
Conditions:
End-Stage Kidney Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 event...
Detailed Description
RESOLVE is a pragmatic, cluster-randomised, open-label study designed to evaluate in real-world conditions the comparative effectiveness of two default dialysate sodium concentrations. Dialysis sites...
Eligibility 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
Key Trial Info
Start Date :
June 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
50000 Patients enrolled
Trial Details
Trial ID
NCT02823821
Start Date
June 1 2016
End Date
December 1 2026
Last Update
April 4 2025
Active Locations (264)
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1
Royal Adelaide Hospital
Adelaide, Australia
2
Auburn Hospital
Auburn, Australia, 2144
3
Flinders Medical Centre
Bedford Park, Australia
4
Moorabbin Hospital
Bentleigh East, Australia, 3165