Randomised Evaluation of Sodium Dialysate Levels on Vascular Events
Recruiting · NCT02823821 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Sydney
View the official record on ClinicalTrials.gov →Interventions studied
Default dialysate sodium concentration of 137mmol/lDefault dialysate sodium concentration of 140mmol/l
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
60 locations listed.
- Royal Adelaide Hospital - Adelaide, Australia
- Nephrologisches Zentrum Albstadt - Albstadt, Germany
- Altrincham General Hospital Dialysis Unit - Altrincham, United Kingdom
- Hospital Ampang - Ampang, Malaysia
- Tameside Renal Dialysis Unit - Ashton-under-Lyne, United Kingdom
- Auburn Hospital - Auburn, Australia
- Barnet Satellite Unit - Barnet, United Kingdom
- Barnsley Dialysis Unit - Barnsley, United Kingdom
- Bath Dialysis Unit - Bath, United Kingdom
- Hospital Sultanah Nora Ismail - Batu Pahat, Malaysia
- Hospital Beaufort - Beaufort, Malaysia
- Bedford Renal Unit - Bedford, United Kingdom
- Flinders Medical Centre - Bedford Park, Australia
- Moorabbin Hospital - Bentleigh East, Australia
- Praxis für Nierenkrankheiten Berlin Hellersdorf - Berlin, Germany
- Bexhill Dialysis Unit - Bexhill-on-Sea, United Kingdom
- Sunshine Coast University Private Hospital - Birtinya, Australia
- Hexagon Towers Dialysis Unit - Blackley, United Kingdom
- Dialyse am Kortumpark Bochum - Bochum, Germany
- Bolton Kidney Care Centre - Bolton, United Kingdom
- St Luke's Hospital Renal Ward - Bradford, United Kingdom
- Bridgwater Dialysis Unit - Bridgwater, United Kingdom
- Brighton Sussex Kidney Unit - Brighton, United Kingdom
- Princess Alexandra Hospital - Brisbane, Australia
- Redlands Hospital - Brisbane, Australia
- Cossham Dialysis Unit - Bristol, United Kingdom
- South Bristol Dialysis Unit - Bristol, United Kingdom
- Bromley Dialysis Unit - Bromley, United Kingdom
- Broomfield Hospital - Broomfield, United Kingdom
- Bundaberg Hospital - Bundaberg, Australia
- Caloundra Hospital - Caloundra, Australia
- Royal Prince Alfred Hospital - Camperdown, Australia
- The Canberra Hospital - Canberra, Australia
- Cannock Haemodialysis Unit - Cannock, United Kingdom
- Chesterfield Dialysis Unit - Chesterfield, United Kingdom
- Clacton (Diaverum) - Clacton-on-Sea, United Kingdom
- Colchester (Diaverum) - Colchester, United Kingdom
- Clay Lane - Coventry, United Kingdom
- University Hospitals Coventry & Warwickshire Main Unit - Coventry, United Kingdom
- Crawley Dialysis Unit - Crawley, United Kingdom
- Leighton - Crewe, United Kingdom
- Cromer Hospital Dialysis Unit - Cromer, United Kingdom
- Darlington Dialysis Unit - Darlington, United Kingdom
- Dialysezentrum Darmstadt - Darmstadt, Germany
- Dartford Dialysis Unit - Dartford, United Kingdom
- Dover Renal Unit - Dover, United Kingdom
- Edgware Satellite Unit - Edgware, United Kingdom
- Dialysezentrum Elsenfeld - Elsenfeld, Germany
- Epsom Dialysis Unit - Epsom, United Kingdom
- Heavitree - Exeter, United Kingdom
- Farnborough Dialysis Unit - Farnborough, United Kingdom
- Peninsula Health - Frankston, Australia
- Hospital Pulau Pinang - George Town, Malaysia
- Cotswold Dialysis Centre - Gloucester, United Kingdom
- Severn - Gloucester, United Kingdom
- James Paget Renal Unit - Great Yarmouth, United Kingdom
- Grimsby Renal Unit - Grimsby, United Kingdom
- Gympie Hospital - Gympie, Australia
- Stoney Creek - Hamilton, Canada
- Harlow Renal Unit - Harlow, United Kingdom
Showing 60 of 264 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →