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New treatment option for End-Stage Kidney Disease
Official title Randomised Evaluation of Sodium Dialysate Levels on Vascular Events
ClinicalTrials.gov ID: NCT02823821
What this study is testing
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- The site 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...
- 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...
You likely can't join if
- are:
- Not able to comply with data collection methods
See the full eligibility criteria
- The site 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...
- are:
- Not able to comply with data collection methods
The study team makes the final eligibility decision.
Where it's taking place
- Adelaide, Australia
- Auburn, Australia
- Bedford Park, Australia
- Bentleigh East, Australia
- Birtinya, Australia
- Brisbane, Australia
- Bundaberg, Australia
- Caloundra, Australia
- Camperdown, Australia
- Canberra, Australia
- Frankston, Australia
- Gympie, Australia
- Ipswich, Australia
- Mackay, Australia
- Meadowbrook, Australia
- Melbourne, Australia
- Nambour, Australia
- Northfield, Australia
- Pialba, Australia
- St Leonards, Australia
+ 197 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Adelaide, Australia; Auburn, Australia; Bedford Park, Australia; Bentleigh East, Australia; Birtinya, Australia; Brisbane, Australia and 211 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.