Randomised Evaluation of Sodium Dialysate Levels on Vascular Events
This worldwide study, called RESOLVE, is looking into how different salt (sodium) levels in dialysis fluid might affect people with advanced kidney disease who are having regular haemodialysis. Doctors already use different sodium levels in dialysis, and this study compares two common ones: 137mmol/l and 140mmol/l. The main goal is to see if one of these levels is better at preventing serious heart-related problems or death. It's a large, real-world study where entire dialysis units will use one of these two sodium levels as their usual practice, and then researchers will observe the health of patients at those units. This helps understand the impact of these small differences in everyday care.
At a glance
What is this study about?
This study, called RESOLVE, is looking at something quite important for people receiving regular haemodialysis for advanced kidney disease. When you have kidney failure, your blood needs to be cleaned by a special machine in a process called dialysis. During this cleaning process, a special fluid called dialysate is used. This fluid contains different substances, including salt, also known as sodium.
Doctors currently use slightly different levels of sodium in this dialysis fluid, and this study wants to find out if one common level is 'better' than another. Specifically, it's comparing a sodium level of 137mmol/l with 140mmol/l. The goal is to see if using one of these levels consistently can help reduce the risk of serious problems like heart attacks, strokes, or even death in people on long-term dialysis. It's a very practical study, meaning it looks at how these things affect patients in their everyday treatment at different dialysis clinics around the world.
Instead of individual patients choosing which level to use, entire dialysis clinics will be randomly assigned to use one of the two sodium levels as their standard practice. This helps researchers understand the 'real-world' effect of these small changes in treatment on a larger scale. All other aspects of your care will continue as usual, according to what your local clinic normally does. The study will then follow patients at these clinics to see if there are any differences in their health over time.
Key takeaways
- Compares two common sodium levels in dialysis fluid: 137mmol/l vs. 140mmol/l.
- Aims to see which level might reduce heart problems or death in dialysis patients.
- Your dialysis clinic might be chosen to use one of these two standard levels.
- Your regular dialysis treatment and care will not change.
- You don't need to do anything different yourself; information is gathered from medical records.
- The study aims to improve future dialysis care for everyone.
Who may be eligible?
This study is focused on dialysis clinics and the patients they treat, rather than individual patients signing up directly. For a dialysis clinic to be part of the study, it generally needs to treat mostly adults (18 and over) who are receiving regular haemodialysis. The clinic also needs to have at least 10 patients at the start of the study and usually use a standard sodium level in their dialysis machines.
Importantly, the clinic must be willing to be randomly chosen to use either the 137mmol/l or 140mmol/l sodium level for most of its dialysis sessions. These units should be self-contained so that patients aren't regularly moving between different units. Home dialysis training units are not included, though clinics that treat both in-centre and home patients might participate, but only the in-centre patients would be part of the study.
If your local dialysis clinic is chosen to be part of this study, you might then be asked if you're happy for your health information to be included. You'll have the option to say yes or no, or even to opt-out if you initially agree. You wouldn't be able to participate if your clinic cannot accurately collect the necessary health information for the study.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Am I 18 years old or older?
- Do I receive regular haemodialysis at a clinic?
- Does my clinic mainly treat adults receiving haemodialysis?
- Is my clinic a standalone unit, rather than patients regularly rotating through other units?
- Is my local clinic able to accurately collect health information for studies?
What does participation involve?
If your dialysis clinic takes part in this study, you won't need to do anything extra or have any different appointments. The study is about slight adjustments to the standard dialysis treatment provided at your clinic. Your clinic will be assigned to use either a default sodium concentration of 137mmol/l or 140mmol/l for at least 90% of all dialysis sessions. Your usual dialysis schedule and all other care will continue as normal, decided by your local healthcare team.
Researchers will collect information about your health from your existing medical records at the clinic. You won't be given new medication or asked to visit more frequently. The overall study is expected to run for an average of approximately 2 to 5 years, but the exact length will depend on when enough information has been gathered about serious health events.
Potential risks and benefits
Locations (264)
- Royal Adelaide HospitalVerified postcodeAdelaide, Australia· Recruiting
- Auburn HospitalVerified postcodeAuburn, Australia· Recruiting
- Flinders Medical CentreVerified postcodeBedford Park, Australia· Recruiting
- Moorabbin HospitalVerified postcodeBentleigh East, Australia· Recruiting
- Sunshine Coast University Private HospitalVerified postcodeBirtinya, Australia· Recruiting
- Princess Alexandra HospitalVerified postcodeBrisbane, Australia· Recruiting
- Redlands HospitalVerified postcodeBrisbane, Australia· Recruiting
- Bundaberg HospitalVerified postcodeBundaberg, Australia· Recruiting
- Caloundra HospitalVerified postcodeCaloundra, Australia· Recruiting
- Royal Prince Alfred HospitalVerified postcodeCamperdown, Australia· Recruiting
- The Canberra HospitalVerified postcodeCanberra, Australia· Recruiting
- Peninsula HealthVerified postcodeFrankston, Australia· Recruiting
Common questions
What is 'dialysate sodium concentration'?
It's the amount of salt (sodium) in the special fluid used to clean your blood during dialysis.
Will I know which sodium level my clinic is using?
Yes, this is an 'open-label' study, meaning the clinics and generally the patients will be aware of which default sodium level their unit is using for treatment.
Will my dialysis schedule change?
No, your dialysis schedule and other aspects of your medical care will not change because of this study. You will continue with your usual treatment.
What kind of 'events' are they looking for?
The study is mainly interested in serious vascular events, like heart attacks or strokes, and whether one sodium level might reduce these risks.
Do I have to do anything differently if my clinic joins?
No, you don't need to do anything differently. Your treatment will continue as normal, and your data will be collected from your existing medical records.
How to find out more
Grace Balicki
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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