RecruitingPhase 4NCT02823821

Randomised Evaluation of Sodium Dialysate Levels on Vascular Events

Sponsor

University of Sydney

Enrollment

50,000 participants

Start Date

Jun 1, 2016

Study Type

INTERVENTIONAL

Conditions

End-stage Kidney Disease

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether using a lower sodium level in dialysis fluid reduces the risk of stroke, heart attack, and other serious vascular events in people receiving kidney dialysis. This is a clinic-level study — dialysis centers are enrolled, not individual patients directly. Eligible dialysis sites must serve mostly adult patients, have at least 10 dialysis patients, and currently use a standard sodium concentration in their dialysis fluid. Sites may NOT be eligible if they cannot collect the required study data. Individual patients at enrolled sites participate as part of the clinic's routine care. Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERDefault dialysate sodium concentration of 137mmol/l

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

OTHERDefault dialysate sodium concentration of 140mmol/l

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

Locations(264)

Royal Adelaide Hospital

Adelaide, Australia

Auburn Hospital

Auburn, Australia

Flinders Medical Centre

Bedford Park, Australia

Moorabbin Hospital

Bentleigh East, Australia

Sunshine Coast University Private Hospital

Birtinya, Australia

Princess Alexandra Hospital

Brisbane, Australia

Redlands Hospital

Brisbane, Australia

Bundaberg Hospital

Bundaberg, Australia

Caloundra Hospital

Caloundra, Australia

Royal Prince Alfred Hospital

Camperdown, Australia

The Canberra Hospital

Canberra, Australia

Peninsula Health

Frankston, Australia

Gympie Hospital

Gympie, Australia

Ipswich Hospital

Ipswich, Australia

Mackay Base Hospital

Mackay, Australia

Logan Hospital

Meadowbrook, Australia

Monash Health Community Dandenong

Melbourne, Australia

Casey Hospital

Melbourne, Australia

Cranbourne Integrated Care Centre

Melbourne, Australia

Nambour General Hospital

Nambour, Australia

Hampstead Dialysis Centre

Northfield, Australia

Hervey Bay Hospital

Pialba, Australia

Royal North Shore Hospital

St Leonards, Australia

Sunshine Coast University Hospital

Sunshine Coast, Australia

Sydney Adventist Hospital

Sydney, Australia

Concord Repatriation and General Hospital

Sydney, Australia

Blacktown Regional Dialysis Centre

Sydney, Australia

Mt Druitt Community Dialysis Centre

Sydney, Australia

Nepean Hospital

Sydney, Australia

Westmead Hospital

Sydney, Australia

The Queen Elizabeth Hospital

Woodville South, Australia

Brantford General Hospital

Brantford, Ontario, Canada

Chatam-Kent Health Alliance

Chatham, Ontario, Canada

St Joseph's Healthcare

Hamilton, Ontario, Canada

Hanover District Hospital

Hanover, Ontario, Canada

Adam Linton Dialysis Unit - Victoria Hospital

London, Ontario, Canada

London Health Sciences Centre

London, Ontario, Canada

Westmount Kidney Care Centre

London, Ontario, Canada

Grey Bruce Health Services

Owen Sound, Ontario, Canada

Bluewater Hospital

Sarnia, Ontario, Canada

Huron Perth Hospital Partnership

Stratford, Ontario, Canada

Tillsonburg District Memorial Hospital

Tillsonburg, Ontario, Canada

Woodstock General Hospital

Woodstock, Ontario, Canada

Stoney Creek

Hamilton, Canada

Belleville

Kingston, Canada

Brockville

Kingston, Canada

Kingston General

Kingston, Canada

Napanee

Kingston, Canada

Perth and Smith Falls

Kingston, Canada

Picton

Kingston, Canada

St. Michael's Hospital

Toronto, Canada

Nephrologisches Zentrum Albstadt

Albstadt, Germany

Praxis für Nierenkrankheiten Berlin Hellersdorf

Berlin, Germany

Dialyse am Kortumpark Bochum

Bochum, Germany

Dialysezentrum Darmstadt

Darmstadt, Germany

Dialysezentrum Elsenfeld

Elsenfeld, Germany

Nephrologisches Zentrum Hechingen

Hechingen, Germany

Arbeitsgemeinschaft Heimdialyse Saar e.V.

Homburg, Germany

Dialysezentrum Langen

Langen, Germany

KfH Nierenzentrum Lichtenfels

Lichtenfels, Germany

Universitätsmedizin Mainz, Dialysestation 605-5E

Mainz, Germany

KfH Nierenzentrum München Schwabing

Munich, Germany

UBAG Öhringen

Öhringen, Germany

Dialysezentrum Schweinfurt

Schweinfurt, Germany

Dialysezentrum Siegburg

Siegburg, Germany

Nephrologie - Dialyse - Christliches Klinikum Unna

Unna, Germany

Nephrologisches Zentrum Villingen-Schwenningen -Tuttlingen

Villingen-Schwenningen, Germany

Area Hospital, Kothapeta Road,Chirala, Andhra Pradesh

Chīrāla, Andhra Pradesh, India

Government General Hospital

Guntur, Andhra Pradesh, India

Medical Superintendent Government Hospital

Gūdūr, Andhra Pradesh, India

Medical Superintendent District Hospital

Hindupur PPP, Andhra Pradesh, India

Government Area Hospital, Kanigiri, Andhra Pradesh

Kanigiri, Andhra Pradesh, India

Government Hospital

Kākināda, Andhra Pradesh, India

Government General Hospital

Kurnool, Andhra Pradesh, India

Government Hospital, Machilipatnam PPP, Andhra Pradesh

Machilipatnam, Andhra Pradesh, India

Government Area Hospital

Mārkāpur, Andhra Pradesh, India

Government Hospital

Nandyāl, Andhra Pradesh, India

Area Hospital

Narsīpatnam, Andhra Pradesh, India

Government Area Hospital

Palakonda, Srikakulam District, Andhra Pradesh, India

CHC Government Hospital

Palāsa, Andhra Pradesh, India

Government Area Hospital

Pārvathipuram, Andhra Pradesh, India

Government Hospital

Proddatūr, Andhra Pradesh, India

Government Hospital

Rajahmundry, Andhra Pradesh, India

CHC Hospital, Sompeta, Andhra Pradesh

Sompeta, Andhra Pradesh, India

Greater Kailash Hospital

Tadepalligudem, Andhra Pradesh, India

Manasa Kidney Foundation

Tirupati, Andhra Pradesh, India

Government General Hospital, Vijayavada PPP, Andhra Pradesh

Vijayawada, Andhra Pradesh, India

King George Government Hospital

Visakhapatnam, Andhra Pradesh, India

Ford Hospital, Khemnichak, Patna

Patna, Bihar, India

Janak Dulari Hospital, Hanuman Nagar

Patna, Bihar, India

Aysha Hospital

Kilpauk, Chennai, India

Retteri Sri Kumaran Health Centre

Kolathūr, Chennai, India

Leelawati Hospital

Ambāla, Haryana, India

Greater Kailash Hospital

Old Palasia, Indore, India

ESI Hospital

Bhetia, Jharkand, India

K.M Memorial Hospital and Research Centre

Bokāro, Jharkhand, India

Asarfi Hospital

Dhanbad, Jharkhand, India

Bhagwan Mahavir Medical Superspeciality Hospital

Ranchi, Jharkhand, India

Guru Nanak Hospital and Research Centre

Ranchi, Jharkhand, India

Koshys Hospital, Ramamurthy Nagar

Bengaluru, Karnataka, India

Nephroplus Basaveshwaranagar

Bengaluru, Karnataka, India

Fortis Suchirayu Hospital

Hubli, Karnataka, India

Main Hospital, SCCL

Kothagudem, Khammam, India

Vishesh Hospital Pvt. Ltd, Geeta Bhawan Chouraha

Indore, Madhya Pradesh, India

Hitwardhak Mandal Hospital

Mumbai, Maharashtra, India

Lokmanya Hospital

Pune, Maharashtra, India

Chirayu Hospital

Thane, Maharashtra, India

Nephroplus Borivali Standalone

Borivali West, Mumbai, India

Bharat Baug

Borivali West, Mumbai, India

Jyothi Hospital

Balasore, Odisha, India

Kar Clinic & Hospital Pvt. Ltd.

Bhubaneswar, Odisha, India

Neelachal Hospital, Kharvel Nagar

Bhubaneswar, Odisha, India

Satguru Partap Singh Apollo Hospitals

Ludhiana, Punjab, India

Deepam Hospitals, Pallavaram

Chennai, Tamil Nadu, India

KG Hospital

Coimbatore, Tamil Nadu, India

Neyveli Lignite Corporation Hospital

Neyveli, Tamil Nadu, India

Sudha Hospital, Vadalur

Neyveli, Tamil Nadu, India

Citizens Specialty Hospital

Hyderabad, Telangana, India

ESI Multi-Specialty Hospital

Hyderabad, Telangana, India

Vintage Plaza Nephroplus, Road no. 10, Banjara Hills

Hyderabad, Telangana, India

Government Hospital

Khammam, Telangana, India

Suraksha Multispecialty Hospital

Nalgonda, Telangana, India

Nephroplus Standalone Dialysis Center, Easy Marredpally

Secunderabad, Telangana, India

Rajiv Gandhi Institute of Medical Sciences, Srikakulam PPP, Andhra

Srikakulam, Telangana, India

Madhuraj Hospital

Kanpur, Uttar Pradesh, India

Ajanta Hospital

Lucknow, Uttar Pradesh, India

Surbhi Hospital Pvt. Ltd, Sector 35

Noida, Uttar Pradish, India

Health Point Hospital, Prannth Pandit Street

Kolkata, West Bengal, India

Minimal Access Surgery Clinic Pvt Ltd

Tamlūk, West Bengal, India

Baroma Sirona Hospital

Uttar Mechgram, West Bengal, India

Hospital Ampang

Ampang, Malaysia

Hospital Sultanah Nora Ismail

Batu Pahat, Malaysia

Hospital Beaufort

Beaufort, Malaysia

Hospital Pulau Pinang

George Town, Malaysia

Pusat Dialisis NKF- Yayasan Dialisis Pendidikan Akhlak Perak

Ipoh, Malaysia

Hospital Sultan Ismail

Johor Bahru, Malaysia

Hospital Sultanah Aminah

Johor Bahru, Malaysia

Hospital Kajang

Kajang, Malaysia

Hospital Serdang

Kajang, Malaysia

Hospital Tuanku Fauziah

Kangar, Malaysia

Pusat Rawatan Dialisis Tuanku Syed Putra - NKF

Kangar, Malaysia

Hospital Tengku Ampuan Rahimah

Klang, Malaysia

Pusat Daillisis NKF - Kelab Apex

Klang, Malaysia

Hospital Raja Perempuan Zainab II

Kota Bharu, Malaysia

Hospital Likas

Kota Kinabalu, Malaysia

Hospital Queen Elizabeth II

Kota Kinabalu, Malaysia

Hospital Kuala Kangsar

Kuala Kangsar, Malaysia

Hospital Kuala Lipis

Kuala Lipis, Malaysia

Hospital Kuala Lumpur

Kuala Lumpur, Malaysia

Pusat Dialisis NKF-Fungates Superflow

Kuala Lumpur, Malaysia

Pusat Dialisis NKF-Nanyang

Kuala Lumpur, Malaysia

Universiti Kebangsaan Malaysia Medical Centre

Kuala Lumpur, Malaysia

University of Malaya Medical Centre

Kuala Lumpur, Malaysia

Hospital Tengku Ampuan Afzan

Kuantan, Malaysia

Hospital Kudat

Kudat, Malaysia

Hospital Kulim

Kulim, Malaysia

Hospital Labuan

Labuan, Malaysia

Hospital Sultanah Bahiyah

Langgar, Malaysia

Haemodialysis Unit Klinik Kesihatan Lenggong

Lenggong, Malaysia

Pusat Hemodialisis Komuniti Cheng

Malacca, Malaysia

Hospital Pakar Sultanah Fatimah

Muar town, Malaysia

Hospital Seberang Jaya

Permatang Pauh, Malaysia

Pusat Dialisis NKF - Chempaka

Petaling Jaya, Malaysia

Hospital Shah Alam

Shah Alam, Malaysia

Universiti Teknologi Mara

Shah Alam, Malaysia

Hospital Sultan Abdul Halim

Sungai Petani, Malaysia

Hospital Sungai Siput

Sungai Siput, Malaysia

Hospital Tambunan

Tambunan, Malaysia

Hospital Sultan Haji Ahmad Shah

Temerluh, Malaysia

Altrincham General Hospital Dialysis Unit

Altrincham, United Kingdom

Tameside Renal Dialysis Unit

Ashton-under-Lyne, United Kingdom

Barnet Satellite Unit

Barnet, United Kingdom

Barnsley Dialysis Unit

Barnsley, United Kingdom

Bath Dialysis Unit

Bath, United Kingdom

Bedford Renal Unit

Bedford, United Kingdom

Bexhill Dialysis Unit

Bexhill-on-Sea, United Kingdom

Hexagon Towers Dialysis Unit

Blackley, United Kingdom

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

Cossham Dialysis Unit

Bristol, United Kingdom

South Bristol Dialysis Unit

Bristol, United Kingdom

Bromley Dialysis Unit

Bromley, United Kingdom

Broomfield Hospital

Broomfield, United Kingdom

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

Dartford Dialysis Unit

Dartford, United Kingdom

Dover Renal Unit

Dover, United Kingdom

Edgware Satellite Unit

Edgware, United Kingdom

Epsom Dialysis Unit

Epsom, United Kingdom

Heavitree

Exeter, United Kingdom

Farnborough Dialysis Unit

Farnborough, United Kingdom

Cotswold Dialysis Centre

Gloucester, United Kingdom

Severn

Gloucester, United Kingdom

James Paget Renal Unit

Great Yarmouth, United Kingdom

Grimsby Renal Unit

Grimsby, United Kingdom

Harlow Renal Unit

Harlow, United Kingdom

Hayes Hospital

Hayes, United Kingdom

Honiton

Honiton, United Kingdom

Chiltern Renal Unit

Houghton Regis, United Kingdom

Fresenius Hull Dialysis Unit

Hull, United Kingdom

West Middlesex

Isleworth, United Kingdom

Kingston Satellite Dialysis Unit

Kingston, United Kingdom

Collierswood Dialysis Unit

London, United Kingdom

King George Hospital

London, United Kingdom

Mary Rankin Satellite Unit

London, United Kingdom

North Wandsworth Dialysis Unit

London, United Kingdom

Royal London Hospital

London, United Kingdom

Whipps Cross Hospital

London, United Kingdom

Ludlow Dialysis Unit

Ludlow, United Kingdom

Macclesfield District General Hospital

Macclesfield, United Kingdom

Manchester Royal Infirmary Renal Dialysis Unit

Manchester, United Kingdom

Octagon Renal Satellite

Manchester, United Kingdom

Margate Renal Unit

Margate, United Kingdom

James Cook

Middlesbrough, United Kingdom

North Ormesby

Middlesbrough, United Kingdom

Harrogate

North Yorks, United Kingdom

Friarage Hospital

Northallerton, United Kingdom

Lucy Deane (George Eliot)

Nuneaton, United Kingdom

Oldham Dialysis Unit

Oldham, United Kingdom

Newham Hospital

Plaistow, United Kingdom

Eastbourne (Polegate) Dialysis Unit

Polegate, United Kingdom

Rochdale Dialysis Unit

Rochdale, United Kingdom

Queen's Hospital

Romford, United Kingdom

Rotherham Dialysis Unit

Rotherham, United Kingdom

St Cross (Ash Unit)

Rugby, United Kingdom

Salford Renal Unit

Salford, United Kingdom

Scarborough

Scarborough, United Kingdom

Scunthorpe Dialysis Centre

Scunthorpe, United Kingdom

Peter Moorhead Unit

Sheffield, United Kingdom

Renal G Floor

Sheffield, United Kingdom

Sheffield Dialysis Unit

Sheffield, United Kingdom

Shrewsbury Renal Unit

Shrewsbury, United Kingdom

Smethwick Dialysis Centre

Smethwick, United Kingdom

St Albans Dialysis Unit

St Albans, United Kingdom

County Hospital

Stafford, United Kingdom

Lister Renal Unit

Stevenage, United Kingdom

Stockport NHS Dialysis Unit

Stockport, United Kingdom

North Tees

Stockton-on-Tees, United Kingdom

Royal Stoke

Stoke-on-Trent, United Kingdom

Stratford Dialysis Centre

Stratford-upon-Avon, United Kingdom

St. Helier Dialysis Unit

Sutton, United Kingdom

Sutton Dialysis Unit

Sutton, United Kingdom

Taunton Dialysis Centre

Taunton, United Kingdom

Hollinswood House Renal Unit

Telford, United Kingdom

Croydon Dialysis Unit

Thornton Heath, United Kingdom

South Devon Satellite Kidney Unit

Torquay, United Kingdom

Tottenham Hale Satellite Unit

Tottenham, United Kingdom

Wigan Renal Unit

Wigan, United Kingdom

Ashford Renal Unit

Willesborough, United Kingdom

Pond Lane Dialysis Unit

Wolverhampton, United Kingdom

Woolwich Dialysis Unit

Woolwich, United Kingdom

Worthing Dialysis Unit

Worthing, United Kingdom

Easingwold

York, United Kingdom

York Hospital

York, United Kingdom

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NCT02823821

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