Randomised Evaluation of Sodium Dialysate Levels on Vascular Events
ConditionEnd-Stage Kidney Disease
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Sydney
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Not able to comply with data collection methods
Trial design
Design model
Parallel
Treatments tested in this trial
Default dialysate sodium concentration of 137mmol/l
Other interventionDefault defined here as use of allocated dialysate sodium concentration for at least 90% of delivered dialysis sessions.
Default dialysate sodium concentration of 140mmol/l
Other interventionDefault defined here as use of allocated dialysate sodium concentration for at least 90% of delivered dialysis sessions.
Treatment groups
50,000 Participants
are divided into 2 treatment groupsGroup A: 137mmol/lActive comparator 1 intervention
Group B: 140mmol/lActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Time to first occurrence of an event in the primary composite outcome
Primary outcome is a composite of major cardiovascular events (hospitalised acute myocardial infarction, hospitalised stroke) and all-cause death. Study completion is endpoint driven, but is expected to be when the average follow up is around 5 years.
Time frame
Through to study completion (estimated to occur after an average of 5 years follow up)Secondary outcomes
1
Time to first occurrence of an event in the secondary composite outcome
Secondary outcome comprises major cardiovascular events (hospitalized acute myocardial infarction, hospitalized stroke), all-cause death and hospitalized heart failure. Study completion is endpoint driven, but is expected to be when the average follow up is around 5 years.
Time frame
Through to study completion (estimated to occur after an average of 5 years follow up)2
Time to first occurrence of each of the individual components of the composite outcomes.
These components are hospitalised myocardial infarctions, hospitalised strokes, hospitalised heart failures and all-cause deaths. Study completion is endpoint driven, but is expected to be when the average follow up is around 5 years.
Time frame
Through to study completion (estimated to occur after an average of 5 years follow up)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Sydney
Lead sponsor
Australasian Kidney Trials Network
Collaborator
Australia & New Zealand Dialysis & Transplant Registry
Collaborator
The George Institute
Collaborator
The George Institute for Global Health, China
Collaborator
Peking University People's Hospital
Collaborator
Institute for Clinical Evaluative Sciences
Collaborator
St. Michaels Hospital
Collaborator
Wuerzburg University Hospital
Collaborator
Malaysian Society of Nephrology
Collaborator
Malaysian Renal Registry
Collaborator
University College, London
Collaborator
Source ClinicalTrials.gov