AzTrials
AzTrials

End-Stage Kidney DiseasePhase 4RESOLVENCT02823821

Randomised Evaluation of Sodium Dialysate Levels on Vascular Events

A Phase 4 study testing Default dialysate sodium concentration of 137mmol/l and Default dialysate sodium concentration of 140mmol/l in people with End-Stage Kidney Disease, run by University of Sydney at 264 sites in 6 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
End-Stage Kidney Disease
What is being tested?
Default dialysate sodium concentration of 137mmol/l and Default dialysate sodium concentration of 140mmol/l
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50,000 participants
Where
264 sitesin 6 countries
Study dates
Jun 2016to Dec 2026
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

264 sites in 6 countries. Contact the study team or a site near you to ask about taking part.

Grace Balicki contact

grace.balicki@sydney.edu.au

Erika Dempsey contact

erika.dempsey@sydney.edu.au

264 sites in 6 countries

United Kingdom95 sites, 95 recruiting

  • Altrincham General Hospital Dialysis Unit

    Altrincham

    Recruiting

  • Tameside Renal Dialysis Unit

    Ashton-under-Lyne

    Recruiting

  • Barnet Satellite Unit

    Barnet

    Recruiting

  • Barnsley Dialysis Unit

    Barnsley

    Recruiting

  • Bath Dialysis Unit

    Bath

    Recruiting

  • Bedford Renal Unit

    Bedford

    Recruiting

  • Bexhill Dialysis Unit

    Bexhill-on-Sea

    Recruiting

  • Hexagon Towers Dialysis Unit

    Blackley

    Recruiting

  • Bolton Kidney Care Centre

    Bolton

    Recruiting

  • St Luke's Hospital Renal Ward

    Bradford

    Recruiting

  • Bridgwater Dialysis Unit

    Bridgwater

    Recruiting

  • Brighton Sussex Kidney Unit

    Brighton

    Recruiting

  • Cossham Dialysis Unit

    Bristol

    Recruiting

  • South Bristol Dialysis Unit

    Bristol

    Recruiting

  • Bromley Dialysis Unit

    Bromley

    Recruiting

  • Broomfield Hospital

    Broomfield

    Recruiting

  • Cannock Haemodialysis Unit

    Cannock

    Recruiting

  • Chesterfield Dialysis Unit

    Chesterfield

    Recruiting

  • Clacton (Diaverum)

    Clacton-on-Sea

    Recruiting

  • Colchester (Diaverum)

    Colchester

    Recruiting

  • Clay Lane

    Coventry

    Recruiting

  • University Hospitals Coventry & Warwickshire Main Unit

    Coventry

    Recruiting

  • Crawley Dialysis Unit

    Crawley

    Recruiting

  • Leighton

    Crewe

    Recruiting

  • Cromer Hospital Dialysis Unit

    Cromer

    Recruiting

  • Darlington Dialysis Unit

    Darlington

    Recruiting

  • Dartford Dialysis Unit

    Dartford

    Recruiting

  • Dover Renal Unit

    Dover

    Recruiting

  • Edgware Satellite Unit

    Edgware

    Recruiting

  • Epsom Dialysis Unit

    Epsom

    Recruiting

  • Heavitree

    Exeter

    Recruiting

  • Farnborough Dialysis Unit

    Farnborough

    Recruiting

  • Cotswold Dialysis Centre

    Gloucester

    Recruiting

  • Severn

    Gloucester

    Recruiting

  • James Paget Renal Unit

    Great Yarmouth

    Recruiting

  • Grimsby Renal Unit

    Grimsby

    Recruiting

  • Harlow Renal Unit

    Harlow

    Recruiting

  • Hayes Hospital

    Hayes

    Recruiting

  • Honiton

    Honiton

    Recruiting

  • Chiltern Renal Unit

    Houghton Regis

    Recruiting

  • Fresenius Hull Dialysis Unit

    Hull

    Recruiting

  • West Middlesex

    Isleworth

    Recruiting

  • Kingston Satellite Dialysis Unit

    Kingston

    Recruiting

  • Collierswood Dialysis Unit

    London

    Recruiting

  • King George Hospital

    London

    Recruiting

  • Mary Rankin Satellite Unit

    London

    Recruiting

  • North Wandsworth Dialysis Unit

    London

    Recruiting

  • Royal London Hospital

    London

    Recruiting

  • Whipps Cross Hospital

    London

    Recruiting

  • Ludlow Dialysis Unit

    Ludlow

    Recruiting

  • Macclesfield District General Hospital

    Macclesfield

    Recruiting

  • Manchester Royal Infirmary Renal Dialysis Unit

    Manchester

    Recruiting

  • Octagon Renal Satellite

    Manchester

    Recruiting

  • Margate Renal Unit

    Margate

    Recruiting

  • James Cook

    Middlesbrough

    Recruiting

  • North Ormesby

    Middlesbrough

    Recruiting

  • Harrogate

    North Yorks

    Recruiting

  • Friarage Hospital

    Northallerton

    Recruiting

  • Lucy Deane (George Eliot)

    Nuneaton

    Recruiting

  • Oldham Dialysis Unit

    Oldham

    Recruiting

  • Newham Hospital

    Plaistow

    Recruiting

  • Eastbourne (Polegate) Dialysis Unit

    Polegate

    Recruiting

  • Rochdale Dialysis Unit

    Rochdale

    Recruiting

  • Queen's Hospital

    Romford

    Recruiting

  • Rotherham Dialysis Unit

    Rotherham

    Recruiting

  • St Cross (Ash Unit)

    Rugby

    Recruiting

  • Salford Renal Unit

    Salford

    Recruiting

  • Scarborough

    Scarborough

    Recruiting

  • Scunthorpe Dialysis Centre

    Scunthorpe

    Recruiting

  • Peter Moorhead Unit

    Sheffield

    Recruiting

  • Renal G Floor

    Sheffield

    Recruiting

  • Sheffield Dialysis Unit

    Sheffield

    Recruiting

  • Shrewsbury Renal Unit

    Shrewsbury

    Recruiting

  • Smethwick Dialysis Centre

    Smethwick

    Recruiting

  • St Albans Dialysis Unit

    St Albans

    Recruiting

  • County Hospital

    Stafford

    Recruiting

  • Lister Renal Unit

    Stevenage

    Recruiting

  • Stockport NHS Dialysis Unit

    Stockport

    Recruiting

  • North Tees

    Stockton-on-Tees

    Recruiting

  • Royal Stoke

    Stoke-on-Trent

    Recruiting

  • Stratford Dialysis Centre

    Stratford-upon-Avon

    Recruiting

  • St. Helier Dialysis Unit

    Sutton

    Recruiting

  • Sutton Dialysis Unit

    Sutton

    Recruiting

  • Taunton Dialysis Centre

    Taunton

    Recruiting

  • Hollinswood House Renal Unit

    Telford

    Recruiting

  • Croydon Dialysis Unit

    Thornton Heath

    Recruiting

  • South Devon Satellite Kidney Unit

    Torquay

    Recruiting

  • Tottenham Hale Satellite Unit

    Tottenham

    Recruiting

  • Wigan Renal Unit

    Wigan

    Recruiting

  • Ashford Renal Unit

    Willesborough

    Recruiting

  • Pond Lane Dialysis Unit

    Wolverhampton

    Recruiting

  • Woolwich Dialysis Unit

    Woolwich

    Recruiting

  • Worthing Dialysis Unit

    Worthing

    Recruiting

  • Easingwold

    York

    Recruiting

  • York Hospital

    York

    Recruiting

Other trials in United Kingdom

India63 sites, 63 recruiting

  • Leelawati Hospital

    Ambāla, Haryana

    Recruiting

  • Jyothi Hospital

    Balasore, Odisha

    Recruiting

  • Koshys Hospital, Ramamurthy Nagar

    Bengaluru, Karnataka

    Recruiting

  • Nephroplus Basaveshwaranagar

    Bengaluru, Karnataka

    Recruiting

  • ESI Hospital

    Bhetia, Jharkand

    Recruiting

  • Kar Clinic & Hospital Pvt. Ltd.

    Bhubaneswar, Odisha

    Recruiting

  • Neelachal Hospital, Kharvel Nagar

    Bhubaneswar, Odisha

    Recruiting

  • K.M Memorial Hospital and Research Centre

    Bokāro, Jharkhand

    Recruiting

  • Nephroplus Borivali Standalone

    Borivali West, Mumbai, 400092

    Kamal D Shah

    Abhinav Bassi

    Recruiting

  • Bharat Baug

    Borivali West, Mumbai

    Recruiting

  • Deepam Hospitals, Pallavaram

    Chennai, Tamil Nadu

    Recruiting

  • Area Hospital, Kothapeta Road,Chirala, Andhra Pradesh

    Chīrāla, Andhra Pradesh

    Recruiting

  • KG Hospital

    Coimbatore, Tamil Nadu

    Recruiting

  • Asarfi Hospital

    Dhanbad, Jharkhand

    Recruiting

  • Medical Superintendent Government Hospital

    Gūdūr, Andhra Pradesh

    Recruiting

  • Government General Hospital

    Guntur, Andhra Pradesh

    Recruiting

  • Medical Superintendent District Hospital

    Hindupur PPP, Andhra Pradesh

    Recruiting

  • Fortis Suchirayu Hospital

    Hubli, Karnataka

    Recruiting

  • Citizens Specialty Hospital

    Hyderabad, Telangana

    Recruiting

  • ESI Multi-Specialty Hospital

    Hyderabad, Telangana

    Recruiting

  • Vintage Plaza Nephroplus, Road no. 10, Banjara Hills

    Hyderabad, Telangana

    Recruiting

  • Vishesh Hospital Pvt. Ltd, Geeta Bhawan Chouraha

    Indore, Madhya Pradesh

    Recruiting

  • Government Hospital

    Kākināda, Andhra Pradesh

    Recruiting

  • Government Area Hospital, Kanigiri, Andhra Pradesh

    Kanigiri, Andhra Pradesh

    Recruiting

  • Madhuraj Hospital

    Kanpur, Uttar Pradesh

    Recruiting

  • Government Hospital

    Khammam, Telangana

    Recruiting

  • Aysha Hospital

    Kilpauk, Chennai

    Recruiting

  • Retteri Sri Kumaran Health Centre

    Kolathūr, Chennai

    Recruiting

  • Health Point Hospital, Prannth Pandit Street

    Kolkata, West Bengal

    Recruiting

  • Main Hospital, SCCL

    Kothagudem, Khammam

    Recruiting

  • Government General Hospital

    Kurnool, Andhra Pradesh

    Recruiting

  • Ajanta Hospital

    Lucknow, Uttar Pradesh

    Recruiting

  • Satguru Partap Singh Apollo Hospitals

    Ludhiana, Punjab

    Recruiting

  • Government Hospital, Machilipatnam PPP, Andhra Pradesh

    Machilipatnam, Andhra Pradesh

    Recruiting

  • Government Area Hospital

    Mārkāpur, Andhra Pradesh

    Recruiting

  • Hitwardhak Mandal Hospital

    Mumbai, Maharashtra

    Kamal D Shah

    Abhinav Bassi

    Recruiting

  • Suraksha Multispecialty Hospital

    Nalgonda, Telangana

    Recruiting

  • Government Hospital

    Nandyāl, Andhra Pradesh

    Recruiting

  • Area Hospital

    Narsīpatnam, Andhra Pradesh

    Recruiting

  • Neyveli Lignite Corporation Hospital

    Neyveli, Tamil Nadu

    Recruiting

  • Sudha Hospital, Vadalur

    Neyveli, Tamil Nadu

    Recruiting

  • Surbhi Hospital Pvt. Ltd, Sector 35

    Noida, Uttar Pradish

    Recruiting

  • Greater Kailash Hospital

    Old Palasia, Indore

    Recruiting

  • Government Area Hospital

    Palakonda, Srikakulam District, Andhra Pradesh

    Recruiting

  • CHC Government Hospital

    Palāsa, Andhra Pradesh

    Recruiting

  • Government Area Hospital

    Pārvathipuram, Andhra Pradesh

    Recruiting

  • Ford Hospital, Khemnichak, Patna

    Patna, Bihar

    Recruiting

  • Janak Dulari Hospital, Hanuman Nagar

    Patna, Bihar

    Recruiting

  • Government Hospital

    Proddatūr, Andhra Pradesh

    Recruiting

  • Lokmanya Hospital

    Pune, Maharashtra

    Recruiting

  • Government Hospital

    Rajahmundry, Andhra Pradesh

    Recruiting

  • Bhagwan Mahavir Medical Superspeciality Hospital

    Ranchi, Jharkhand

    Recruiting

  • Guru Nanak Hospital and Research Centre

    Ranchi, Jharkhand

    Recruiting

  • Nephroplus Standalone Dialysis Center, Easy Marredpally

    Secunderabad, Telangana

    Recruiting

  • CHC Hospital, Sompeta, Andhra Pradesh

    Sompeta, Andhra Pradesh

    Recruiting

  • Rajiv Gandhi Institute of Medical Sciences, Srikakulam PPP, Andhra

    Srikakulam, Telangana

    Recruiting

  • Greater Kailash Hospital

    Tadepalligudem, Andhra Pradesh

    Recruiting

  • Minimal Access Surgery Clinic Pvt Ltd

    Tamlūk, West Bengal

    Recruiting

  • Chirayu Hospital

    Thane, Maharashtra

    Recruiting

  • Manasa Kidney Foundation

    Tirupati, Andhra Pradesh

    Recruiting

  • Baroma Sirona Hospital

    Uttar Mechgram, West Bengal

    Recruiting

  • Government General Hospital, Vijayavada PPP, Andhra Pradesh

    Vijayawada, Andhra Pradesh

    Recruiting

  • King George Government Hospital

    Visakhapatnam, Andhra Pradesh

    Recruiting

Other trials in India

Malaysia39 sites, 38 recruiting

  • Hospital Ampang

    Ampang

    Recruiting

  • Hospital Sultanah Nora Ismail

    Batu Pahat

    Recruiting

  • Hospital Beaufort

    Beaufort

    Recruiting

  • Hospital Pulau Pinang

    George Town

    Recruiting

  • Pusat Dialisis NKF- Yayasan Dialisis Pendidikan Akhlak Perak

    Ipoh

    Recruiting

  • Hospital Sultan Ismail

    Johor Bahru

    Recruiting

  • Hospital Sultanah Aminah

    Johor Bahru

    Recruiting

  • Hospital Kajang

    Kajang

    Recruiting

  • Hospital Serdang

    Kajang

    Recruiting

  • Hospital Tuanku Fauziah

    Kangar

    Completed

  • Pusat Rawatan Dialisis Tuanku Syed Putra - NKF

    Kangar

    Recruiting

  • Hospital Tengku Ampuan Rahimah

    Klang

    Recruiting

  • Pusat Daillisis NKF - Kelab Apex

    Klang

    Recruiting

  • Hospital Raja Perempuan Zainab II

    Kota Bharu

    Recruiting

  • Hospital Likas

    Kota Kinabalu

    Recruiting

  • Hospital Queen Elizabeth II

    Kota Kinabalu

    Recruiting

  • Hospital Kuala Kangsar

    Kuala Kangsar

    Recruiting

  • Hospital Kuala Lipis

    Kuala Lipis

    Recruiting

  • Hospital Kuala Lumpur

    Kuala Lumpur

    Recruiting

  • Pusat Dialisis NKF-Fungates Superflow

    Kuala Lumpur

    Recruiting

  • Pusat Dialisis NKF-Nanyang

    Kuala Lumpur

    Recruiting

  • Universiti Kebangsaan Malaysia Medical Centre

    Kuala Lumpur

    Recruiting

  • University of Malaya Medical Centre

    Kuala Lumpur

    Recruiting

  • Hospital Tengku Ampuan Afzan

    Kuantan

    Recruiting

  • Hospital Kudat

    Kudat

    Recruiting

  • Hospital Kulim

    Kulim

    Recruiting

  • Hospital Labuan

    Labuan

    Recruiting

  • Hospital Sultanah Bahiyah

    Langgar

    Recruiting

  • Haemodialysis Unit Klinik Kesihatan Lenggong

    Lenggong

    Recruiting

  • Pusat Hemodialisis Komuniti Cheng

    Malacca

    Recruiting

  • Hospital Pakar Sultanah Fatimah

    Muar town

    Recruiting

  • Hospital Seberang Jaya

    Permatang Pauh

    Recruiting

  • Pusat Dialisis NKF - Chempaka

    Petaling Jaya

    Recruiting

  • Hospital Shah Alam

    Shah Alam

    Recruiting

  • Universiti Teknologi Mara

    Shah Alam

    Recruiting

  • Hospital Sultan Abdul Halim

    Sungai Petani

    Recruiting

  • Hospital Sungai Siput

    Sungai Siput

    Recruiting

  • Hospital Tambunan

    Tambunan

    Recruiting

  • Hospital Sultan Haji Ahmad Shah

    Temerluh

    Recruiting

Other trials in Malaysia

Australia31 sites, 31 recruiting

  • Royal Adelaide Hospital

    Adelaide

    Recruiting

  • Auburn Hospital

    Auburn, 2144

    Recruiting

  • Flinders Medical Centre

    Bedford Park

    Recruiting

  • Moorabbin Hospital

    Bentleigh East, 3165

    Recruiting

  • Sunshine Coast University Private Hospital

    Birtinya

    Recruiting

  • Princess Alexandra Hospital

    Brisbane, 4102

    Recruiting

  • Redlands Hospital

    Brisbane, 4163

    Recruiting

  • Bundaberg Hospital

    Bundaberg

    Recruiting

  • Caloundra Hospital

    Caloundra, 4551

    Recruiting

  • Royal Prince Alfred Hospital

    Camperdown

    Recruiting

  • The Canberra Hospital

    Canberra

    Recruiting

  • Peninsula Health

    Frankston, 3199

    Recruiting

  • Gympie Hospital

    Gympie, 4570

    Recruiting

  • Ipswich Hospital

    Ipswich, 4305

    Recruiting

  • Mackay Base Hospital

    Mackay

    Recruiting

  • Logan Hospital

    Meadowbrook, 4131

    Recruiting

  • Monash Health Community Dandenong

    Melbourne, 3175

    Recruiting

  • Casey Hospital

    Melbourne, 3806

    Recruiting

  • Cranbourne Integrated Care Centre

    Melbourne, 3977

    Recruiting

  • Nambour General Hospital

    Nambour, 4560

    Recruiting

  • Hampstead Dialysis Centre

    Northfield

    Recruiting

  • Hervey Bay Hospital

    Pialba

    Recruiting

  • Royal North Shore Hospital

    St Leonards

    Recruiting

  • Sunshine Coast University Hospital

    Sunshine Coast, 4575

    Recruiting

  • Sydney Adventist Hospital

    Sydney, 2076

    Recruiting

  • Concord Repatriation and General Hospital

    Sydney, 2139

    Recruiting

  • Blacktown Regional Dialysis Centre

    Sydney, 2148

    Recruiting

  • Mt Druitt Community Dialysis Centre

    Sydney, 2770

    Recruiting

  • Nepean Hospital

    Sydney

    Recruiting

  • Westmead Hospital

    Sydney

    Recruiting

  • The Queen Elizabeth Hospital

    Woodville South

    Recruiting

Other trials in Australia

Canada20 sites, 20 recruiting

  • Brantford General Hospital

    Brantford, Ontario

    Recruiting

  • Chatam-Kent Health Alliance

    Chatham, Ontario

    Recruiting

  • St Joseph's Healthcare

    Hamilton, Ontario

    Recruiting

  • Stoney Creek

    Hamilton

    Recruiting

  • Hanover District Hospital

    Hanover, Ontario

    Recruiting

  • Belleville

    Kingston

    Recruiting

  • Brockville

    Kingston

    Recruiting

  • Kingston General

    Kingston

    Recruiting

  • Napanee

    Kingston

    Recruiting

  • Perth and Smith Falls

    Kingston

    Recruiting

  • Picton

    Kingston

    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

  • Huron Perth Hospital Partnership

    Stratford, Ontario

    Recruiting

  • Tillsonburg District Memorial Hospital

    Tillsonburg, Ontario

    Recruiting

  • St. Michael's Hospital

    Toronto

    Recruiting

  • Woodstock General Hospital

    Woodstock, Ontario

    Recruiting

Other trials in Canada

Germany16 sites, 16 recruiting

  • Nephrologisches Zentrum Albstadt

    Albstadt

    Recruiting

  • Praxis für Nierenkrankheiten Berlin Hellersdorf

    Berlin

    Recruiting

  • Dialyse am Kortumpark Bochum

    Bochum

    Recruiting

  • Dialysezentrum Darmstadt

    Darmstadt

    Recruiting

  • Dialysezentrum Elsenfeld

    Elsenfeld

    Recruiting

  • Nephrologisches Zentrum Hechingen

    Hechingen

    Recruiting

  • Arbeitsgemeinschaft Heimdialyse Saar e.V.

    Homburg

    Recruiting

  • Dialysezentrum Langen

    Langen

    Recruiting

  • KfH Nierenzentrum Lichtenfels

    Lichtenfels

    Recruiting

  • Universitätsmedizin Mainz, Dialysestation 605-5E

    Mainz

    Recruiting

  • KfH Nierenzentrum München Schwabing

    Munich

    Recruiting

  • UBAG Öhringen

    Öhringen

    Recruiting

  • Dialysezentrum Schweinfurt

    Schweinfurt

    Recruiting

  • Dialysezentrum Siegburg

    Siegburg

    Recruiting

  • Nephrologie - Dialyse - Christliches Klinikum Unna

    Unna

    Recruiting

  • Nephrologisches Zentrum Villingen-Schwenningen -Tuttlingen

    Villingen-Schwenningen, 78052

    Recruiting

Other trials in Germany

About this study

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.

Read the detailed description

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.

Being tested
Default dialysate sodium concentration of 137mmol/l, Default dialysate sodium concentration of 140mmol/l
Keywords
End-Stage Kidney Disease, Hemodialysis, Dialysate, Sodium, Cluster-randomisation, Dialysis, RESOLVE
Medical subject headings
Kidney Failure, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Default dialysate sodium concentration of 137mmol/lOther

    Default defined here as use of allocated dialysate sodium concentration for at least 90% of delivered dialysis sessions.

  • Default dialysate sodium concentration of 140mmol/lOther

    Default defined here as use of allocated dialysate sodium concentration for at least 90% of delivered dialysis sessions.

Study groups in NCT02823821
Study groupRoleWhat they receive
137mmol/lActive comparatorParticipating dialysis sites will be randomised to a default dialysate sodium concentration of 137mmol/l
Receives: Other: Default dialysate sodium concentration of 137mmol/l
140mmol/lActive comparatorParticipating dialysis sites will be randomised to a default dialysate sodium concentration of 140mmol/l
Receives: Other: Default dialysate sodium concentration of 140mmol/l

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to first occurrence of an event in the primary composite outcome

    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.

    Measured: Through to study completion (estimated to occur after an average of 5 years follow up)

Secondary outcomes (2)

  1. Time to first occurrence of an event in the secondary composite outcome

    Secondary outcome comprises major cardiovascular events (hospitalized acute myocardial infarction, hospitalized stroke), all-cause death and hospitalized heart failure. Study completion is endpoint driven, but is expected to be when the average follow up is around 5 years.

    Measured: Through to study completion (estimated to occur after an average of 5 years follow up)

  2. Time to first occurrence of each of the individual components of the composite outcomes.

    These components are hospitalised myocardial infarctions, hospitalised strokes, hospitalised heart failures and all-cause deaths. Study completion is endpoint driven, but is expected to be when the average follow up is around 5 years.

    Measured: Through to study completion (estimated to occur after an average of 5 years follow up)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jul 2016 (estimated)
  2. Study startJun 2016
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
50,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02823821
Sponsor's protocol ID
GI-AU-RM-2016-01
Acronym
RESOLVE
Status last verified
Apr 2025
First submitted
16 Jun 2016
Last updated
4 Apr 2025
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Pinter J, Canaud B, Mayne KJ, Stuard S, Moissl U, Kooman J, Jager KJ, Chesnaye NC, Smyth B, Genser B. Associations of Abnormal Fluid Status, Plasma Sodium Disorders, and Low Dialysate Sodium with Mortality in Patients on Hemodialysis. Clin J Am Soc Nephrol. 2024 Nov 1;19(11):1444-1452. doi: 10.2215/CJN.0000000000000552. Epub 2024 Sep 10.

    PubMed 39514693

  • Marshall MR, Wang MY, Vandal AC, Dunlop JL. Low dialysate sodium levels for chronic haemodialysis. Cochrane Database Syst Rev. 2024 Nov 5;11(11):CD011204. doi: 10.1002/14651858.CD011204.pub3.

    PubMed 39498822

  • See EJ, Polkinghorne KR. Volume management in haemodialysis patients. Curr Opin Nephrol Hypertens. 2020 Nov;29(6):663-670. doi: 10.1097/MNH.0000000000000642.

    PubMed 32889978

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Default dialysate sodium concentration of 137mmol/l and Default dialysate sodium concentration of 140mmol/l in people with End-Stage Kidney Disease, run by University of Sydney at 264 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 264 sites in United Kingdom, India, Malaysia, Australia, Canada and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Grace Balicki (grace.balicki@sydney.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02823821, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.

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