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.
RESOLVE is a pragmatic, cluster-randomised, open-label trial 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 2-5 years with average study duration expected to be approximately 5 years. The actual length of the study will be end-point determined.
The study will involve a staged roll-out. The initial Development Phase will ascertain the feasibility of implementing the study protocol. The vanguard phase will continue to implement the protocol and allow testing of study assumptions. The main phase will conclude the study.
|Treatment||Default dialysate sodium concentration of 137mmol/l, Default dialysate sodium concentration of 140mmol/l|
|Clinical Study Identifier||NCT02823821|
|Sponsor||The George Institute|
|Last Modified on||23 November 2020|
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