End-Stage Kidney Disease
Conditions
Keywords
End-Stage Kidney Disease, Hemodialysis, Dialysate, Sodium, Cluster-randomisation, Dialysis, RESOLVE
Brief summary
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
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.
Interventions
OTHERDefault dialysate sodium concentration of 137mmol/l
Default defined here as use of allocated dialysate sodium concentration for at least 90% of delivered dialysis sessions.
OTHERDefault dialysate sodium concentration of 140mmol/l
Default defined here as use of allocated dialysate sodium concentration for at least 90% of delivered dialysis sessions.
Sponsors
Australasian Kidney Trials Network
Australia & New Zealand Dialysis & Transplant Registry
The George Institute
The George Institute for Global Health, China
Peking University People's Hospital
Institute for Clinical Evaluative Sciences
St. Michaels Hospital
University Hospital Wuerzburg, Medizinische Klinik EINS
Malaysian Society of Nephrology
Malaysian Renal Registry
Comprehensive Clinical Trials Unit, University College London
University of Sydney
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to first occurrence of an event in the primary composite outcome | Through to study completion (estimated to occur after an average of 5 years follow up) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to first occurrence of an event in the secondary composite outcome | Through to study completion (estimated to occur after an average of 5 years follow up) | 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 to first occurrence of each of the individual components of the composite outcomes. | Through to study completion (estimated to occur after an average of 5 years follow up) | 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. |
Countries
Australia, Canada, Germany, India, Malaysia, United Kingdom
Contacts
Primary ContactGrace Balicki
Backup ContactErika Dempsey
Outcome results
None listed