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Evaluating the impact of sodium levels in dialysis on heart events

Randomised Evaluation of Sodium Dialysate Levels on Vascular Events

Phase 4 Interventional University of Sydney · NCT02823821

This study is testing whether using different levels of sodium in dialysis can help reduce heart problems and deaths in people who are on hemodialysis.

Quick facts

PhasePhase 4
Study typeInterventional
Enrollment50000 (estimated)
Ages18 Years and up
SexAll
SponsorUniversity of Sydney Academic / other
Locations264 sites (Adelaide and 263 other locations)
Trial IDNCT02823821 on ClinicalTrials.gov

What this trial studies

This global study assesses the effects of two different sodium concentrations in dialysate on major cardiovascular events and mortality in patients undergoing maintenance hemodialysis. Dialysis sites will be randomly assigned to use either 137mmol/l or 140mmol/l sodium concentrations as their default for the majority of dialysis sessions. The study is designed to reflect real-world conditions and will involve a pragmatic, cluster-randomised approach. Outcomes will be evaluated based on individual patient data from participating dialysis centers over a period of 2-5 years.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older who are receiving maintenance hemodialysis.

Not a fit: Patients who are not receiving hemodialysis or those undergoing home dialysis may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved cardiovascular outcomes and reduced mortality for patients with end-stage kidney disease undergoing hemodialysis.

How similar studies have performed: Other studies have explored sodium levels in dialysis, but this specific approach of comparing two default concentrations in a cluster-randomised manner is relatively novel.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Adelaide and 263 other locations

+214 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions End-Stage Kidney DiseaseHemodialysisDialysateSodiumCluster-randomisationDialysisRESOLVE
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.