Randomised Evaluation of Sodium Dialysate Levels on Vascular Events

NCT02823821 · tracked via the Priya Life Science India tracker

Sponsor

University of Sydney

Phase

Phase 4

Started

2016-06

Last updated

2025-04-04

Condition(s) studied

End-Stage Kidney Disease

Investigational drug(s) / intervention(s)

Default dialysate sodium concentration of 137mmol/lDefault dialysate sodium concentration of 140mmol/l

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.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

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.

Trial sites (264)

Facility	City	Region	Status
Royal Adelaide Hospital	Adelaide	Australia	Recruiting
Auburn Hospital	Auburn	Australia	Recruiting
Flinders Medical Centre	Bedford Park	Australia	Recruiting
Moorabbin Hospital	Bentleigh East	Australia	Recruiting
Sunshine Coast University Private Hospital	Birtinya	Australia	Recruiting
Princess Alexandra Hospital	Brisbane	Australia	Recruiting
Redlands Hospital	Brisbane	Australia	Recruiting
Bundaberg Hospital	Bundaberg	Australia	Recruiting
Caloundra Hospital	Caloundra	Australia	Recruiting
Royal Prince Alfred Hospital	Camperdown	Australia	Recruiting
The Canberra Hospital	Canberra	Australia	Recruiting
Peninsula Health	Frankston	Australia	Recruiting
Gympie Hospital	Gympie	Australia	Recruiting
Ipswich Hospital	Ipswich	Australia	Recruiting
Mackay Base Hospital	Mackay	Australia	Recruiting
Logan Hospital	Meadowbrook	Australia	Recruiting
Monash Health Community Dandenong	Melbourne	Australia	Recruiting
Casey Hospital	Melbourne	Australia	Recruiting
Cranbourne Integrated Care Centre	Melbourne	Australia	Recruiting
Nambour General Hospital	Nambour	Australia	Recruiting
Hampstead Dialysis Centre	Northfield	Australia	Recruiting
Hervey Bay Hospital	Pialba	Australia	Recruiting
Royal North Shore Hospital	St Leonards	Australia	Recruiting
Sunshine Coast University Hospital	Sunshine Coast	Australia	Recruiting
Sydney Adventist Hospital	Sydney	Australia	Recruiting
Concord Repatriation and General Hospital	Sydney	Australia	Recruiting
Blacktown Regional Dialysis Centre	Sydney	Australia	Recruiting
Mt Druitt Community Dialysis Centre	Sydney	Australia	Recruiting
Nepean Hospital	Sydney	Australia	Recruiting
Westmead Hospital	Sydney	Australia	Recruiting
The Queen Elizabeth Hospital	Woodville South	Australia	Recruiting
Brantford General Hospital	Brantford	Ontario	Recruiting
Chatam-Kent Health Alliance	Chatham	Ontario	Recruiting
St Joseph's Healthcare	Hamilton	Ontario	Recruiting
Hanover District Hospital	Hanover	Ontario	Recruiting
Adam Linton Dialysis Unit - Victoria Hospital	London	Ontario	Recruiting
London Health Sciences Centre	London	Ontario	Recruiting
Westmount Kidney Care Centre	London	Ontario	Recruiting
Grey Bruce Health Services	Owen Sound	Ontario	Recruiting
Bluewater Hospital	Sarnia	Ontario	Recruiting

+ 224 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02823821 on ClinicalTrials.gov ↗ ← All trials in India