No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Health Services Research
Participants needed
50,000 (estimated)
Sponsor
University of Sydney · Other
Who this trial is looking for
This trial is looking for adults on maintenance dialysis to see how different sodium levels in the dialysate affect heart events and death. Participants will be randomly assigned to one of two sodium concentrations during their dialysis treatments.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old.
I am receiving maintenance haemodialysis.
My dialysis site has had less than 15% of patients leave for social reasons in the past two years.
There are at least 10 dialysis patients at my site.
My dialysis site uses a default sodium concentration for most treatments.
I agree to be randomly assigned to one of the treatment groups.
My dialysis unit does not mainly support home dialysis patients.
You may not be able to join if
I am unable to comply with data collection methods.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 events and death in patients receiving maintenance haemodialysis.
Trial Locations
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Facility
City
State
Country
Status
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 increa…
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
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