Randomised Evaluation of SOdium dialysate Levels on Vascular Events (RESOLVE)
Overview
RESOLVE (Reducing Cardiovascular Events with Sevelamer in Dialysis) is a large, registry-embedded clinical trial testing whether treatment with sevelamer reduces cardiovascular events in people receiving haemodialysis. 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. It is run by the NHMRC Clinical Trials Centre at the University of Sydney in collaboration with ANZDATA.
The trial compares sevelamer with standard phosphate binders to assess whether it lowers the risk of major cardiovascular events, including heart attack and stroke, in adults on haemodialysis. Conducted across dialysis units in Australia and New Zealand, RESOLVE is funded by the NHMRC and is currently recruiting participants through participating dialysis centres.
| 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 |
| Target Recruitment: | Participants across Australia and New Zealand |
Research Team
Prof Meg Jardine
Principle Investigator, Director of the CTC and the CTC’s Kidney Health Research Director
Background
Chronic kidney disease leading to kidney failure is a growing global health issue, driven by rising rates of diabetes, high blood pressure, and obesity. For people with kidney failure, dialysis or transplantation can sustain life — but dialysis patients face a significantly shortened life expectancy, with survival outcomes worse than for most common cancers. The leading cause of death in this group is cardiovascular disease, including heart attacks, strokes, and heart failure, which accounts for around half of all deaths in people receiving dialysis.
One major contributor to cardiovascular disease in dialysis patients is sodium and fluid overload. Despite advances in dialysis technology, most patients still experience excess sodium retention and fluid accumulation, which leads to high blood pressure, blood vessel damage, and increased strain on the heart. Finding effective ways to reduce sodium and fluid overload remains a key priority in dialysis care.
Dialysate — the fluid used during dialysis — contains sodium, and lowering its sodium concentration is a simple, low-cost strategy that may help reduce sodium accumulation in patients. However, reducing dialysate sodium may also increase the risk of intradialytic hypotension (unstable blood pressure during dialysis), raising concerns about potential harm. These competing risks highlight the need for rigorous testing in a large-scale clinical trial.
Currently, dialysate sodium concentrations vary widely between dialysis centres, typically ranging from 135 to 142 mmol/L — a practice based more on local custom than on evidence. The RESOLVE trial was designed to replace this variation with a carefully controlled, randomised approach, allowing researchers to determine whether differences in dialysate sodium concentration impact patient outcomes, particularly major cardiovascular events and mortality.
RESOLVE is a pragmatic, cluster randomised, open-label trial evaluating whether default dialysate sodium concentration affects cardiovascular outcomes in people on haemodialysis. The trial is led globally by the NHMRC Clinical Trials Centre at the University of Sydney, with Australian coordination through the Australasian Kidney Trials Network at the University of Queensland. RESOLVE is supported by the ANZDATA Registry, which contributes data collection and analysis in Australia and New Zealand.
The study is being rolled out in stages across multiple countries, with participant data collected pragmatically through national dialysis registries where available.
References
NHMRC Clinical Trials Centre. RESOLVE: Randomised Evaluation of Sodium Dialysate Levels on Vascular Events [Internet]. Sydney (AU): University of Sydney; [cited 2025 Jul 22]. Available from: https://ctc.usyd.edu.au/our-research/research-areas/kidney-health/active-trials/resolve/
Study Aims
RESOLVE aims to determine whether, for patients receiving maintenance haemodialysis, treatment at a centre with a default dialysate sodium concentration of 137 mmol/L reduces the risk of major cardiovascular events and all-cause mortality compared with treatment at a centre using a default dialysate sodium of 140 mmol/L.
Study Design and Population
| Design: | Pragmatic, cluster randomised, open-label controlled trial conducted in real-world dialysis settings |
| Setting: | Haemodialysis centres in Australia, China, Canada, India, Germany, Malaysia, and the United Kingdom, with further expansion planned in South Africa, France, and the United States |
| Randomisation: |
|
| Participants: |
|
| Primary Outcome: | Time to first occurrence of a major cardiovascular event (heart attack, stroke) or all-cause mortality |
| Study Duration: | Ongoing until sufficient outcome events are observed to allow robust comparison between groups |
| Eligibility Criteria for Participating Sites: |
|
Contact Us
ANZDATA Coordinator: Lavern Greenham, Email: trials@anzdata.org.au
Phone:(08) 8128 4758
Email: resolve.study@sydney.edu.au | Email RESOLVE AKTN: resolve@uq.edu.au
Phone: +61 8 8222 6841
Ethics approval
Sydney Local Health District Human Research Ethics Committee – Concord Repatriation General Hospital
HREC/16/CRGH/107