Testing Default dialysate sodium concentration for end-stage kidney disease
Official title: Randomised Evaluation of Sodium Dialysate Levels on Vascular Events
- Phase 4
- 2 groups
- Sites in Hamilton, Kingston and 10 more cities
- Recruiting
Interventions
- Other intervention
Default dialysate sodium concentration of 137mmol/l
Default defined here as use of allocated dialysate sodium concentration for at least 90% of delivered dialysis sessions.
- Other intervention
Default dialysate sodium concentration of 140mmol/l
Default defined here as use of allocated dialysate sodium concentration for at least 90% of delivered dialysis sessions.
Canadian Sites (20)
20 of 20 recruiting
- Recruiting
Stoney Creek
Hamilton
- Recruiting
Belleville
Kingston
- Recruiting
Brockville
Kingston
- Recruiting
Kingston General
Kingston
- Recruiting
Napanee
Kingston
- Recruiting
Perth and Smith Falls
Kingston
- Recruiting
Picton
Kingston
- Recruiting
Brantford General Hospital
Brantford, Ontario
- Recruiting
Chatam-Kent Health Alliance
Chatham, Ontario
- Recruiting
St Joseph's Healthcare
Hamilton, Ontario
- Recruiting
Hanover District Hospital
Hanover, Ontario
- Recruiting
Adam Linton Dialysis Unit - Victoria Hospital
London, Ontario
- Recruiting
London Health Sciences Centre
London, Ontario
- Recruiting
Westmount Kidney Care Centre
London, Ontario
- Recruiting
Grey Bruce Health Services
Owen Sound, Ontario
- Recruiting
Bluewater Hospital
Sarnia, Ontario
- Recruiting
Huron Perth Hospital Partnership
Stratford, Ontario
- Recruiting
Tillsonburg District Memorial Hospital
Tillsonburg, Ontario
- Recruiting
Woodstock General Hospital
Woodstock, Ontario
- Recruiting
St. Michael's Hospital
Toronto
Eligibility Criteria
See who this study is looking for10 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +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 randomisationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →
- +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 siteTrial siteA hospital or clinic where a study is actually run.Read more →)
- +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 criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are:
- +Not able to comply with data collection methods
Exclusion
- −Not able to comply with data collection methods
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is looking at how care is delivered and organised, rather than at a treatment itself.
Phase 4Phase 4A study of a treatment that is already approved and in use.Read more → — a study of a treatment already approved for use, following it in everyday practice.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A, the comparison group, receives Default dialysate sodium concentration of 137mmol/l.
Registry label: A: 137mmol/l
Group B, the comparison group, receives Default dialysate sodium concentration of 140mmol/l.
Registry label: B: 140mmol/l
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 50,000 people.
The study is currently expected to finish around December 2026.
The main measurement is taken over: Through to study completion (estimated to occur after an average of 5 years follow upFollow-upContinued check-ins after the treatment part is finished.Read more →).
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Time to first occurrence of an event in the primary composite outcome — measured over Through to study completion (estimated to occur after an average of 5 years follow upFollow-upContinued check-ins after the treatment part is finished.Read more →).
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT02823821 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Default dialysate sodium concentration of 137mmol/lOther
Default defined here as use of allocated dialysate sodium concentration for at least 90% of delivered dialysis sessions.
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
About Default dialysate sodium concentration of 140mmol/lOther
Default defined here as use of allocated dialysate sodium concentration for at least 90% of delivered dialysis sessions.
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Through to study completion (estimated to occur after an average of 5 years follow upFollow-upContinued check-ins after the treatment part is finished.Read more →).
The study as a whole is currently expected to finish around 2026-12.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 50,000 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 13 locations, including: Hamilton, Canada; Kingston, Canada; Toronto, Canada; Brantford, Ontario, Canada; Chatham, Ontario, Canada; Hamilton, Ontario, Canada, and 7 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
Think this trial might be right for you?
Complete a quick intake form and we will match you with this and other relevant trials based on your medical profile.
See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.