NCT02823821

Randomised Evaluation of Sodium Dialysate Levels on Vascular Events

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50,000 (estimated)
• Sponsor: University of Sydney · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• End-Stage Kidney Disease

Interventions

Type	Name	Description
OTHER	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	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.

Timeline

• Start date: 2016-06-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2016-07-06
• Last updated: 2025-04-04

Locations

264 sites across 6 countries: Australia, Canada, Germany, India, Malaysia, United Kingdom