Evaluating the impact of sodium levels in dialysis on heart events

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Royal Adelaide Hospital
  Adelaide, Australia Recruiting
• Auburn Hospital
  Auburn, Australia Recruiting
• Flinders Medical Centre
  Bedford Park, Australia Recruiting
• Moorabbin Hospital
  Bentleigh East, Australia Recruiting
• Sunshine Coast University Private Hospital
  Birtinya, Australia Recruiting
• Princess Alexandra Hospital
  Brisbane, Australia Recruiting

+214 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Jule Pinter — Wuerzburg University Hospital
• Study coordinator: Grace Balicki
• Email: grace.balicki@sydney.edu.au

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.