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Looking for participantsPhase4

Randomised Evaluation of Sodium Dialysate Levels on Vascular Events

Sponsor: University of Sydney

NCT ID: NCT02823821

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Default dialysate sodium concentration of 137mmol/l (other), Default dialysate sodium concentration of 140mmol/l (other)
How long the study runs
Study runs about 126 months (dates as stated)
About the drug or intervention
Default dialysate sodium concentration of 137mmol/l — other: 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 — other: Default defined here as use of allocated dialysate sodium concentration for at least 90% of delivered dialysis sessions.
Patient visit burden
Not specified by the sponsor

In plain English

This study looks at end-stage kidney disease and whether different sodium levels in the fluid used during haemodialysis (a treatment that filters the blood when the kidneys no longer work) affect the risk of problems with blood vessels. It is sponsored by the University of Sydney.

Who can take part

  • Adults aged 18 or over who receive regular haemodialysis at a dialysis unit taking part in the study
  • The dialysis unit must usually use one standard sodium level in the dialysis fluid for most sessions
  • The dialysis unit must be willing to be randomly assigned (by chance) to either study group
  • The unit must have at least 10 people on dialysis when it joins the study

Who may not be able to

  • People who cannot follow the study's data collection methods
  • Home dialysis training or support units (though units with both in-centre and home patients can take part, with only in-centre patients included)

What taking part involves

  • • Not stated — ask the trial team

Time commitment: Not stated — ask the trial team about what taking part involves, including visits and how long the study lasts.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
50,000
Started
2016-06
Last checked
2025-04

Plain English Summary

What is this study?

  • • Testing a new treatment for end-stage kidney disease
  • • Phase4 - 50,000 participants
  • • 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?

  • • Ages 18 Years and over
  • • Diagnosed with end-stage kidney disease

Where?

  • • Altrincham - Altrincham General Hospital Dialysis Unit
  • • Ashton-under-Lyne - Tameside Renal Dialysis Unit
  • • Barnet - Barnet Satellite Unit
  • • Barnsley - Barnsley Dialysis Unit
  • • +91 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

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 will be randomised in a 1:1 ratio to a default dialysate sodium concentration of 137mmol/l or 140mmol/l. 'Default' is defined as the use of the allocated dialysate sodium for ≥ 90% of delivered dialysis sessions in the unit. All other care will be according to standard local practices as determined by the site. Outcomes will be assessed on individual patients dialysing at those sites. Sites will be asked to consent to participation while waiver or opt-out consent will be sought for individual patients. It is anticipated that site accrual will occur over 5-7 years with average study duration expected to be approximately 2-5 years. The actual length of the study will be end-point determined.

End-Stage Kidney Disease

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

What the study is looking for

  • ✓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...
  • ✓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...
See the full 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

Where Is This Study? (95 UK sites)

Altrincham General Hospital Dialysis Unit

Altrincham, United Kingdom

Recruiting

Tameside Renal Dialysis Unit

Ashton-under-Lyne, United Kingdom

Recruiting

Barnet Satellite Unit

Barnet, United Kingdom

Recruiting

Barnsley Dialysis Unit

Barnsley, United Kingdom

Recruiting
Hospital R&D contact (matched)

RM&G Office

barnsley.research@nhs.net01226 432348

Bath Dialysis Unit

Bath, United Kingdom

Recruiting
Hospital R&D contact (matched)

Professor Julie Barnett (Associate Pro Vice-Chancellor, Research)

pro-vc-research@bath.ac.uk1225383162

Bedford Renal Unit

Bedford, United Kingdom

Recruiting

Bexhill Dialysis Unit

Bexhill-on-Sea, United Kingdom

Recruiting

Hexagon Towers Dialysis Unit

Blackley, United Kingdom

Recruiting

Bolton Kidney Care Centre

Bolton, United Kingdom

Recruiting
Hospital R&D contact (matched)

Alison Loftus. R&D Co-ordinator

alison.loftus@boltonft.nhs.uk01204 390390 ext. 3848

St Luke's Hospital Renal Ward

Bradford, United Kingdom

Recruiting

Bridgwater Dialysis Unit

Bridgwater, United Kingdom

Recruiting

Brighton Sussex Kidney Unit

Brighton, United Kingdom

Recruiting
Hospital R&D contact (matched)

Scott Harfield

uhsussex.research@nhs.net01273 696955 ext. 67497

Cossham Dialysis Unit

Bristol, United Kingdom

Recruiting

South Bristol Dialysis Unit

Bristol, United Kingdom

Recruiting

Bromley Dialysis Unit

Bromley, United Kingdom

Recruiting

Broomfield Hospital

Broomfield, United Kingdom

Recruiting
Hospital R&D contact (matched)

Main Email: mse.lehprimarycareresearch@nhs.net

mse.lehprimarycareresearch@nhs.net01245 516339

Cannock Haemodialysis Unit

Cannock, United Kingdom

Recruiting

Chesterfield Dialysis Unit

Chesterfield, United Kingdom

Recruiting

Clacton (Diaverum)

Clacton-on-Sea, United Kingdom

Recruiting

Colchester (Diaverum)

Colchester, United Kingdom

Recruiting

Clay Lane

Coventry, United Kingdom

Recruiting

University Hospitals Coventry & Warwickshire Main Unit

Coventry, United Kingdom

Recruiting
Hospital R&D contact (matched)

Josie Goodby

research@uhcw.nhs.uk02476 965244

Crawley Dialysis Unit

Crawley, United Kingdom

Recruiting

Leighton

Crewe, United Kingdom

Recruiting
Hospital R&D contact (matched)

Charis Emmett

charis.emmett@mcht.nhs.uk01270 278095

Cromer Hospital Dialysis Unit

Cromer, United Kingdom

Recruiting

Darlington Dialysis Unit

Darlington, United Kingdom

Recruiting

Dartford Dialysis Unit

Dartford, United Kingdom

Recruiting

Dover Renal Unit

Dover, United Kingdom

Recruiting

Edgware Satellite Unit

Edgware, United Kingdom

Recruiting

Epsom Dialysis Unit

Epsom, United Kingdom

Recruiting

Heavitree

Exeter, United Kingdom

Recruiting

Farnborough Dialysis Unit

Farnborough, United Kingdom

Recruiting

Cotswold Dialysis Centre

Gloucester, United Kingdom

Recruiting

Severn

Gloucester, United Kingdom

Recruiting

James Paget Renal Unit

Great Yarmouth, United Kingdom

Recruiting
Hospital R&D contact (matched)

rd.office@jpaget.nhs.uk

rd.office@jpaget.nhs.uk01493 453478

Grimsby Renal Unit

Grimsby, United Kingdom

Recruiting

Harlow Renal Unit

Harlow, United Kingdom

Recruiting

Hayes Hospital

Hayes, United Kingdom

Recruiting

Honiton

Honiton, United Kingdom

Recruiting

Chiltern Renal Unit

Houghton Regis, United Kingdom

Recruiting

Fresenius Hull Dialysis Unit

Hull, United Kingdom

Recruiting
Hospital R&D contact (matched)

James Illingworth

hyp-tr.development.research@nhs.net01482 461883 or 461903

West Middlesex

Isleworth, United Kingdom

Recruiting

Kingston Satellite Dialysis Unit

Kingston, United Kingdom

Recruiting

Collierswood Dialysis Unit

London, United Kingdom

Recruiting

King George Hospital

London, United Kingdom

Recruiting

Mary Rankin Satellite Unit

London, United Kingdom

Recruiting

North Wandsworth Dialysis Unit

London, United Kingdom

Recruiting

Royal London Hospital

London, United Kingdom

Recruiting
Hospital R&D contact (matched)

Natasha Ajraam

rf-tr.randd@nhs.net020 375 82150

Whipps Cross Hospital

London, United Kingdom

Recruiting

Ludlow Dialysis Unit

Ludlow, United Kingdom

Recruiting

Macclesfield District General Hospital

Macclesfield, United Kingdom

Recruiting
Hospital R&D contact (matched)

Head of Clinical Governance

ecn-tr.ResearchandDevelopment@nhs.net01625 661018

Manchester Royal Infirmary Renal Dialysis Unit

Manchester, United Kingdom

Recruiting
Hospital R&D contact (matched)

Elizabeth Mainwaring

R&D.applications@mft.nhs.uk0161 276 3340

Octagon Renal Satellite

Manchester, United Kingdom

Recruiting

Margate Renal Unit

Margate, United Kingdom

Recruiting

James Cook

Middlesbrough, United Kingdom

Recruiting
Hospital R&D contact (matched)

Research and Development

stees.dtvra@nhs.net01642 854089

North Ormesby

Middlesbrough, United Kingdom

Recruiting

Harrogate

North Yorks, United Kingdom

Recruiting
Hospital R&D contact (matched)

Michelle Platton

hdft.research@nhs.net01423 555692

Friarage Hospital

Northallerton, United Kingdom

Recruiting

Lucy Deane (George Eliot)

Nuneaton, United Kingdom

Recruiting
Hospital R&D contact (matched)

Nyaradzo Rosemary Musanhu

rosemary.musanhu@geh.nhs.uk02476 153152

Oldham Dialysis Unit

Oldham, United Kingdom

Recruiting

Newham Hospital

Plaistow, United Kingdom

Recruiting

Eastbourne (Polegate) Dialysis Unit

Polegate, United Kingdom

Recruiting

Rochdale Dialysis Unit

Rochdale, United Kingdom

Recruiting

Queen's Hospital

Romford, United Kingdom

Recruiting
Hospital R&D contact (matched)

Heidi Chandler

bhrut.development.research@nhs.net01708 435000 ex 2923

Rotherham Dialysis Unit

Rotherham, United Kingdom

Recruiting
Hospital R&D contact (matched)

Rachel Walker

rgh-tr.researchanddevelopment@nhs.net01709 426066

St Cross (Ash Unit)

Rugby, United Kingdom

Recruiting

Salford Renal Unit

Salford, United Kingdom

Recruiting

Scarborough

Scarborough, United Kingdom

Recruiting
Hospital R&D contact (matched)

Lydia Harris

yhs-tr.research.governance@nhs.net01904 726606

Scunthorpe Dialysis Centre

Scunthorpe, United Kingdom

Recruiting

Peter Moorhead Unit

Sheffield, United Kingdom

Recruiting

Renal G Floor

Sheffield, United Kingdom

Recruiting

Sheffield Dialysis Unit

Sheffield, United Kingdom

Recruiting
Hospital R&D contact (matched)

Alessia Dunn

STH.ResearchAdministration@nhs.net0114 2712550

Shrewsbury Renal Unit

Shrewsbury, United Kingdom

Recruiting

Smethwick Dialysis Centre

Smethwick, United Kingdom

Recruiting

St Albans Dialysis Unit

St Albans, United Kingdom

Recruiting

County Hospital

Stafford, United Kingdom

Recruiting
Hospital R&D contact (matched)

Anthony Homer. Research Governance Manager

Research@dchft.nhs.uk01305 253 127

Lister Renal Unit

Stevenage, United Kingdom

Recruiting

Stockport NHS Dialysis Unit

Stockport, United Kingdom

Recruiting
Hospital R&D contact (matched)

Research, Development & Innovation Office

research.development@stockport.nhs.uk0161 419 5893

North Tees

Stockton-on-Tees, United Kingdom

Recruiting
Hospital R&D contact (matched)

Research and Development

nth-tr.ntandh.researchdevelopment@nhs.net01642 624090

Royal Stoke

Stoke-on-Trent, United Kingdom

Recruiting
Hospital R&D contact (matched)

Sarah Jones

studysetup@uhnm.nhs.uk01782 675385

Stratford Dialysis Centre

Stratford-upon-Avon, United Kingdom

Recruiting

St. Helier Dialysis Unit

Sutton, United Kingdom

Recruiting
Hospital R&D contact (matched)

Please contact ESTH.Research@nhs.net

ESTH.Research@nhs.net0208 2964699

Sutton Dialysis Unit

Sutton, United Kingdom

Recruiting

Taunton Dialysis Centre

Taunton, United Kingdom

Recruiting

Hollinswood House Renal Unit

Telford, United Kingdom

Recruiting

Croydon Dialysis Unit

Thornton Heath, United Kingdom

Recruiting
Hospital R&D contact (matched)

Non Portfolio - Michael Chang Portfolio - South West Cluster Office

ch-tr.research@nhs.net0208 401 3610

South Devon Satellite Kidney Unit

Torquay, United Kingdom

Recruiting
Hospital R&D contact (matched)

Dr Fiona Roberts (R&D Director)

tsdft.research@nhs.net01803 656635

Tottenham Hale Satellite Unit

Tottenham, United Kingdom

Recruiting

Wigan Renal Unit

Wigan, United Kingdom

Recruiting

Ashford Renal Unit

Willesborough, United Kingdom

Recruiting

Pond Lane Dialysis Unit

Wolverhampton, United Kingdom

Recruiting

Woolwich Dialysis Unit

Woolwich, United Kingdom

Recruiting

Worthing Dialysis Unit

Worthing, United Kingdom

Recruiting

Easingwold

York, United Kingdom

Recruiting

York Hospital

York, United Kingdom

Recruiting
Hospital R&D contact (matched)

Lydia Harris

yhs-tr.research.governance@nhs.net01904 726606

How to Get in Touch

Grace Balicki

Sponsor contact

CONTACT

grace.balicki@sydney.edu.au

Erika Dempsey

Sponsor contact

CONTACT

erika.dempsey@sydney.edu.au
Data sourced from ClinicalTrials.gov · Last verified: 2025-04