Randomised Evaluation of Sodium Dialysate Levels on Vascular Events
Launched by UNIVERSITY OF SYDNEY · Jul 5, 2016
Trial Information
Current as of July 16, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial, titled "Randomised Evaluation of Sodium Dialysate Levels on Vascular Events," is studying how different levels of sodium in the dialysis fluid affect the health of patients with end-stage kidney disease. Specifically, the trial will compare two sodium concentrations—140mmol/l and 137mmol/l—to see if they have any impact on serious heart problems or death in patients who are undergoing regular dialysis treatment. The study is currently recruiting participants aged 65 to 74 years, and anyone receiving maintenance hemodialysis who meets certain criteria may be eligible to join.
Participants in this trial can expect to be randomly assigned to one of the two sodium levels during their dialysis sessions. To be eligible, dialysis centers must have a stable group of adult patients and should primarily use the same sodium concentration for most treatments. It's important that participating centers are self-contained, meaning that patients do not regularly switch between different locations. This study aims to help improve the care of patients on dialysis by understanding how these sodium levels can affect overall health.
Gender
ALL
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
About University Of Sydney
The University of Sydney is a leading research institution in Australia, renowned for its commitment to advancing medical science and improving healthcare outcomes through innovative clinical trials. With a robust infrastructure and a multidisciplinary team of experts, the university fosters a collaborative environment that integrates cutting-edge research with clinical practice. The institution emphasizes ethical standards, patient safety, and scientific rigor in its trials, aiming to translate findings into real-world applications that benefit diverse populations. Through its dedication to excellence and impact, the University of Sydney continues to contribute significantly to the fields of medicine and public health.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Brisbane, Queensland, Australia
Adelaide, , Australia
London, Ontario, Canada
Kuala Lumpur, , Malaysia
St Leonards, , Australia
Sydney, , Australia
Broomfield, , United Kingdom
Bedford Park, , Australia
Ampang, , Malaysia
Brisbane, , Australia
York, , United Kingdom
Camperdown, , Australia
Macclesfield, , United Kingdom
London, , United Kingdom
Romford, , United Kingdom
Hamilton, Ontario, Canada
Kuala Lumpur, , Malaysia
London, , United Kingdom
Toronto, , Canada
Kota Bharu, , Malaysia
Kuantan, , Malaysia
Stafford, , United Kingdom
Sydney, , Australia
Bentleigh East, , Australia
George Town, , Malaysia
Johor Bahru, , Malaysia
Kajang, , Malaysia
Canberra, , Australia
Johor Bahru, , Malaysia
Northallerton, , United Kingdom
Auburn, , Australia
Brisbane, , Australia
Bundaberg, , Australia
Caloundra, , Australia
Frankston, , Australia
Gympie, , Australia
Ipswich, , Australia
Mackay, , Australia
Meadowbrook, , Australia
Melbourne, , Australia
Melbourne, , Australia
Melbourne, , Australia
Nambour, , Australia
Northfield, , Australia
Pialba, , Australia
Sunshine Coast, , Australia
Sydney, , Australia
Sydney, , Australia
Sydney, , Australia
Sydney, , Australia
Woodville South, , Australia
Brantford, Ontario, Canada
Chatham, Ontario, Canada
Hanover, Ontario, Canada
London, Ontario, Canada
London, Ontario, Canada
Owen Sound, Ontario, Canada
Sarnia, Ontario, Canada
Stratford, Ontario, Canada
Tillsonburg, Ontario, Canada
Woodstock, Ontario, Canada
Hamilton, , Canada
Kingston, , Canada
Kingston, , Canada
Kingston, , Canada
Kingston, , Canada
Kingston, , Canada
Kingston, , Canada
Berlin, , Germany
Elsenfeld, , Germany
Homburg, , Germany
Lichtenfels, , Germany
Mainz, , Germany
Schweinfurt, , Germany
Villingen Schwenningen, , Germany
Chirala, Andhra Pradesh, India
Gudur, Andhra Pradesh, India
Guntur, Andhra Pradesh, India
Hindupur Ppp, Andhra Pradesh, India
Kanigiri, Andhra Pradesh, India
Kurnool, Andhra Pradesh, India
Kākināda, Andhra Pradesh, India
Machilipatnam, Andhra Pradesh, India
Markapur, Andhra Pradesh, India
Nandyal, Andhra Pradesh, India
Narsipatnam, Andhra Pradesh, India
Palakonda, Srikakulam District, Andhra Pradesh, India
Palasa, Andhra Pradesh, India
Parvathipuram, Andhra Pradesh, India
Proddatur, Andhra Pradesh, India
Rajahmundry, Andhra Pradesh, India
Sompeta, Andhra Pradesh, India
Tadepalligudem, Andhra Pradesh, India
Tirupati, Andhra Pradesh, India
Vijayavada, Andhra Pradesh, India
Visakhapatnam, Andhra Pradesh, India
Srikakulam, Andhra, India
Patna, Bihar, India
Patna, Bihar, India
Kilpauk, Chennai, India
Kolathur, Chennai, India
Ambāla, Haryana, India
Old Palasia, Indore, India
Adityapur, Jharkand, India
Bokaro, Jharkhand, India
Dhanbad, Jharkhand, India
Ranchi, Jharkhand, India
Ranchi, Jharkhand, India
Bengaluru, Karnataka, India
Bengaluru, Karnataka, India
Hubli, Karnataka, India
Kothagudem, Khammam, India
Indore, Madhya Pradesh, India
Mumbai, Maharashtra, India
Pune, Maharashtra, India
Thāne, Maharashtra, India
Borivali West, Mumbai, India
Borivali West, Mumbai, India
Balasore, Odisha, India
Bhubaneswar, Odisha, India
Bhubaneswar, Odisha, India
Ludhiāna, Punjab, India
Coimbatore, Tamil Nadu, India
Neyveli, Tamil Nadu, India
Chennai, Tamilnadu, India
Neyveli, Tamilnadu, India
Hyderabad, Telangana, India
Hyderabad, Telangana, India
Hyderabad, Telangana, India
Khammam, Telangana, India
Nalgonda, Telangana, India
Secunderabad, Telangana, India
Kanpur, Uttar Pradesh, India
Lucknow, Uttar Pradesh, India
Noida, Uttar Pradish, India
Kolkata, West Bengal, India
Tamluk, West Bengal, India
Uttar Mechgram, West Bengal, India
Muar, , Malaysia
Sungai Petani, , Malaysia
Birtinya, , Australia
Bochum, , Germany
Munich, , Germany
Batu Pahat, , Malaysia
Beaufort, , Malaysia
Ipoh, , Malaysia
Kajang, , Malaysia
Kangar, , Malaysia
Kangar, , Malaysia
Klang, , Malaysia
Klang, , Malaysia
Kota Kinabalu, , Malaysia
Kota Kinabalu, , Malaysia
Kuala Kangsar, , Malaysia
Kuala Lipis, , Malaysia
Kuala Lumpur, , Malaysia
Kuala Lumpur, , Malaysia
Kuala Lumpur, , Malaysia
Kudat, , Malaysia
Kulim, , Malaysia
Labuan, , Malaysia
Langgar, , Malaysia
Lenggong, , Malaysia
Malaka, , Malaysia
Permatang Pauh, , Malaysia
Petaling Jaya, , Malaysia
Shah Alam, , Malaysia
Shah Alam, , Malaysia
Sungai Siput, , Malaysia
Tambunan, , Malaysia
Temerluh, , Malaysia
Barnet, , United Kingdom
Edgware, , United Kingdom
London, , United Kingdom
Plaistow, , United Kingdom
Albstadt, , Germany
Hechingen, , Germany
öhringen, , Germany
Altrincham, , United Kingdom
Bolton, , United Kingdom
Brighton, , United Kingdom
Colchester, , United Kingdom
Coventry, , United Kingdom
Exeter, , United Kingdom
Hayes, , United Kingdom
Hull, , United Kingdom
London, , United Kingdom
Middlesbrough, , United Kingdom
Middlesbrough, , United Kingdom
Sheffield, , United Kingdom
Tottenham, , United Kingdom
Wigan, , United Kingdom
Darmstadt, , Germany
Langen, , Germany
Siegburg, , Germany
Unna, , Germany
Ashton Under Lyne, , United Kingdom
Barnsley, , United Kingdom
Bath, , United Kingdom
Bedford, , United Kingdom
Bexhill On Sea, , United Kingdom
Blackley, , United Kingdom
Bradford, , United Kingdom
Bridgwater, , United Kingdom
Bristol, , United Kingdom
Bristol, , United Kingdom
Bromley, , United Kingdom
Cannock, , United Kingdom
Chesterfield, , United Kingdom
Clacton On Sea, , United Kingdom
Coventry, , United Kingdom
Crawley, , United Kingdom
Crewe, , United Kingdom
Cromer, , United Kingdom
Darlington, , United Kingdom
Dartford, , United Kingdom
Dover, , United Kingdom
Epsom, , United Kingdom
Farnborough, , United Kingdom
Gloucester, , United Kingdom
Gloucester, , United Kingdom
Great Yarmouth, , United Kingdom
Grimsby, , United Kingdom
Harlow, , United Kingdom
Honiton, , United Kingdom
Houghton Regis, , United Kingdom
Isleworth, , United Kingdom
Kingston, , United Kingdom
London, , United Kingdom
London, , United Kingdom
Ludlow, , United Kingdom
Manchester, , United Kingdom
Manchester, , United Kingdom
Margate, , United Kingdom
North Yorkshire, , United Kingdom
Nuneaton, , United Kingdom
Oldham, , United Kingdom
Polegate, , United Kingdom
Rochdale, , United Kingdom
Rotherham, , United Kingdom
Rugby, , United Kingdom
Salford, , United Kingdom
Scarborough, , United Kingdom
Scunthorpe, , United Kingdom
Sheffield, , United Kingdom
Sheffield, , United Kingdom
Shrewsbury, , United Kingdom
Smethwick, , United Kingdom
St Albans, , United Kingdom
Stevenage, , United Kingdom
Stockport, , United Kingdom
Stockton On Tees, , United Kingdom
Stoke On Trent, , United Kingdom
Stratford Upon Avon, , United Kingdom
Sutton, , United Kingdom
Sutton, , United Kingdom
Taunton, , United Kingdom
Telford, , United Kingdom
Thornton Heath, , United Kingdom
Torquay, , United Kingdom
Willesborough, , United Kingdom
Wolverhampton, , United Kingdom
Woolwich, , United Kingdom
Worthing, , United Kingdom
York, , United Kingdom
Patients applied
Trial Officials
Meg Jardine
Study Director
The University of Sydney, NHMRC Clinical Trials Centre
Carmel Hawley
Study Chair
The University of Queensland
Vivekanand Jha
Study Chair
The George Institute India
Zuo Li
Study Chair
Peking University People's Hospital
Sunita Bavanandan
Study Chair
Kuala Lumpur General Hospital
David Wheeler
Study Chair
Comprehensive Clinical Trials Unit, University College London
Patrick Rossignol
Study Chair
INSERM Clinical Investigation Centre
Mike Walsh
Study Chair
McMaster University
Vlado Perkovic
Study Chair
University of New South Wales
Christoph Wanner
Study Chair
University Hospital Wuerzburg
Jule Pinter
Principal Investigator
University Hospital Wuerzburg
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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