Status:

RECRUITING

Randomised Evaluation of Sodium Dialysate Levels on Vascular Events

Lead Sponsor:

University of Sydney

Collaborating Sponsors:

Australasian Kidney Trials Network

Australia & New Zealand Dialysis & Transplant Registry

Conditions:

End-Stage Kidney Disease

Eligibility:

All Genders

18+ years

Phase:

PHASE4

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 event...

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...

Eligibility 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

Key Trial Info

Start Date :

June 1 2016

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2026

Estimated Enrollment :

50000 Patients enrolled

Trial Details

Trial ID

NCT02823821

Start Date

June 1 2016

End Date

December 1 2026

Last Update

April 4 2025

Active Locations (264)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 66 (264 locations)

1

Royal Adelaide Hospital

Adelaide, Australia

2

Auburn Hospital

Auburn, Australia, 2144

3

Flinders Medical Centre

Bedford Park, Australia

4

Moorabbin Hospital

Bentleigh East, Australia, 3165