Randomised Evaluation of Sodium Dialysate Levels on Vascular Events

Study Overview
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Brief Summary
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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.

Detailed Description
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RESOLVE is a pragmatic, cluster-randomised, open-label study designed to evaluate in real-world conditions the comparative effectiveness of two default dialysate sodium concentrations. Dialysis sites will be randomised in a 1:1 ratio to a default dialysate sodium concentration of 137mmol/l or 140mmol/l. 'Default' is defined as the use of the allocated dialysate sodium for ≥ 90% of delivered dialysis sessions in the unit. All other care will be according to standard local practices as determined by the site. Outcomes will be assessed on individual patients dialysing at those sites. Sites will be asked to consent to participation while waiver or opt-out consent will be sought for individual patients. It is anticipated that site accrual will occur over 5-7 years with average study duration expected to be approximately 2-5 years. The actual length of the study will be end-point determined.

Official Title
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Randomised Evaluation of Sodium Dialysate Levels on Vascular Events

Conditions
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End-Stage Kidney Disease

Intervention / Treatment
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* Other: Default dialysate sodium concentration of 137mmol/l
* Other: Default dialysate sodium concentration of 140mmol/l


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 137mmol/l<br>Participating dialysis sites will be randomised to a default dialysate sodium concentration of 137mmol/l | Other: Default dialysate sodium concentration of 137mmol/l<br>* Default defined here as use of allocated dialysate sodium concentration for at least 90% of delivered dialysis sessions.<br>|
| Active Comparator: 140mmol/l<br>Participating dialysis sites will be randomised to a default dialysate sodium concentration of 140mmol/l | Other: Default dialysate sodium concentration of 140mmol/l<br>* Default defined here as use of allocated dialysate sodium concentration for at least 90% of delivered dialysis sessions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Through to study completion (estimated to occur after an average of 5 years follow up) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Through to study completion (estimated to occur after an average of 5 years follow up) | 
| 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. | Through to study completion (estimated to occur after an average of 5 years follow up) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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End-Stage Kidney Disease, Hemodialysis, Dialysate, Sodium, Cluster-randomisation, Dialysis, RESOLVE