Clinical trial 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
- The study wants to find out whether using a slightly lower sodium concentration in dialysis fluid changes the rate of major heart events or death in patients with end‑stage kidney disease.
- Who it's for
- It is looking for adults who are already receiving regular haemodialysis for kidney failure.
- What's involved
- Participants will receive their usual dialysis treatment, but the sodium level in the dialysis fluid will be set to either 140mmol/l or 137mmol/l. They will have routine dialysis visits and any standard tests that are part of their care.
- Time commitment
- The study lasts for the duration of the patient’s dialysis treatment, with regular dialysis sessions and routine follow‑up visits as scheduled by their dialysis center.
- 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
- 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...
- Is a self-contained unit (i.e. unit patients do not regularly rotate through another unit.
You likely can't join if
- Not able to comply with data collection methods
See the full eligibility criteria
- 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...
- Not able to comply with data collection methods
The study team makes the final eligibility decision.
Where it is enrolling
- 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, but 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?
This study is enrolling now at Adelaide, Australia; Auburn, Australia; Bedford Park, Australia; Bentleigh East, Australia; Birtinya, Australia; Brisbane, Australia and 211 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.