Recruiting

Sodium Dialysate

Sponsor:

University of Sydney

Code:

NCT02823821

Conditions

End-Stage Kidney Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Default dialysate sodium concentration of 137mmol/l

Default dialysate sodium concentration of 140mmol/l

Study Details

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.

Conditions

End-Stage Kidney Disease

Study ID

NCT02823821

Start date

Jun, 2016

Status verified date

Apr, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50000 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

active comparator: 137mmol/l

Participating dialysis sites will be randomised to a default dialysate sodium concentration of 137mmol/l

active comparator: 140mmol/l

Participating dialysis sites will be randomised to a default dialysate sodium concentration of 140mmol/l

Interventions

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.

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.

Primary outcome measure

  • Time to first occurrence of an event in the primary composite outcome [ Time Frame: Through to study completion (estimated to occur after an average of 5 years follow up) ]

Central Contacts and Locations

Central contacts

Grace Balicki

grace.balicki@sydney.edu.au

Erika Dempsey

erika.dempsey@sydney.edu.au

Locations

Brantford General Hospital

Recruiting

Brantford, Ontario, Canada

Chatam-Kent Health Alliance

Recruiting

Chatham, Ontario, Canada

St Joseph's Healthcare

Recruiting

Hamilton, Ontario, Canada

Hanover District Hospital

Recruiting

Hanover, Ontario, Canada

Adam Linton Dialysis Unit - Victoria Hospital

Recruiting

London, Ontario, Canada

London Health Sciences Centre

Recruiting

London, Ontario, Canada

Westmount Kidney Care Centre

Recruiting

London, Ontario, Canada

Grey Bruce Health Services

Recruiting

Owen Sound, Ontario, Canada

Bluewater Hospital

Recruiting

Sarnia, Ontario, Canada

Huron Perth Hospital Partnership

Recruiting

Stratford, Ontario, Canada

Tillsonburg District Memorial Hospital

Recruiting

Tillsonburg, Ontario, Canada

Woodstock General Hospital

Recruiting

Woodstock, Ontario, Canada

Stoney Creek

Recruiting

Hamilton, Canada

Belleville

Recruiting

Kingston, Canada

Brockville

Recruiting

Kingston, Canada

Kingston General

Recruiting

Kingston, Canada

Napanee

Recruiting

Kingston, Canada

Perth and Smith Falls

Recruiting

Kingston, Canada

Picton

Recruiting

Kingston, Canada

St. Michael's Hospital

Recruiting

Toronto, Canada

More Information

Sponsor

University of Sydney

Last update posted

Apr 4, 2025

Last verified

Apr, 2025

Keywords

  • End-Stage Kidney Disease
  • Hemodialysis
  • Dialysate
  • Sodium
  • Cluster-randomisation
  • Dialysis
  • RESOLVE

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Sydney on 2025-04-04.