Randomised Evaluation of Sodium Dialysate Levels on Vascular Events
- Conditions
- End-Stage Kidney Disease
- Interventions
- Other: Default dialysate sodium concentration of 140mmol/lOther: Default dialysate sodium concentration of 137mmol/l
- Registration Number
- NCT02823821
- Lead Sponsor
- University of Sydney
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50000
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 140mmol/l Default dialysate sodium concentration of 140mmol/l Participating dialysis sites will be randomised to a default dialysate sodium concentration of 140mmol/l 137mmol/l Default dialysate sodium concentration of 137mmol/l Participating dialysis sites will be randomised to a default dialysate sodium concentration of 137mmol/l
- Primary Outcome Measures
Name Time Method Time to first occurrence of an event in the primary composite outcome Through to study completion (estimated to occur after an average of 5 years follow up) 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.
- Secondary Outcome Measures
Name Time Method Time to first occurrence of each of the individual components of the composite outcomes. Through to study completion (estimated to occur after an average of 5 years follow up) 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.
Time to first occurrence of an event in the secondary composite outcome Through to study completion (estimated to occur after an average of 5 years follow up) 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.
Trial Locations
- Locations (256)
Sunshine Coast University Private Hospital
🇦🇺Birtinya, Australia
KfH Nierenzentrum Lichtenfels
🇩🇪Lichtenfels, Germany
Hospital Sultanah Aminah
🇲🇾Johor Bahru, Malaysia
Hospital Tengku Ampuan Rahimah
🇲🇾Klang, Malaysia
Pusat Daillisis NKF - Kelab Apex
🇲🇾Klang, Malaysia
Haemodialysis Unit Klinik Kesihatan Lenggong
🇲🇾Lenggong, Malaysia
Chiltern Renal Unit
🇬🇧Houghton Regis, United Kingdom
Octagon Renal Satellite
🇬🇧Manchester, United Kingdom
Auburn Hospital
🇦🇺Auburn, Australia
Oldham Dialysis Unit
🇬🇧Oldham, United Kingdom
Sudha Hospital, Vadalur
🇮🇳Neyveli, Tamil Nadu, India
KG Hospital
🇮🇳Coimbatore, Tamil Nadu, India
Government General Hospital
🇮🇳Kurnool, Andhra Pradesh, India
K.M Memorial Hospital and Research Centre
🇮🇳Bokaro, Jharkhand, India
Retteri Sri Kumaran Health Centre
🇮🇳Kolathur, Chennai, India
Bharat Baug
🇮🇳Borivali West, Mumbai, India
CHC Hospital, Sompeta, Andhra Pradesh
🇮🇳Sompeta, Andhra Pradesh, India
Government General Hospital, Vijayavada PPP, Andhra Pradesh
🇮🇳Vijayavada, Andhra Pradesh, India
Medical Superintendent Government Hospital
🇮🇳Gudur, Andhra Pradesh, India
Government Hospital
🇮🇳Khammam, Telangana, India
Area Hospital
🇮🇳Narsipatnam, Andhra Pradesh, India
Medical Superintendent District Hospital
🇮🇳Hindupur PPP, Andhra Pradesh, India
Main Hospital, SCCL
🇮🇳Kothagudem, Khammam, India
Surbhi Hospital Pvt. Ltd, Sector 35
🇮🇳Noida, Uttar Pradish, India
Hospital Kajang
🇲🇾Kajang, Malaysia
Ford Hospital, Khemnichak, Patna
🇮🇳Patna, Bihar, India
Suraksha Multispecialty Hospital
🇮🇳Nalgonda, Telangana, India
Aysha Hospital
🇮🇳Kilpauk, Chennai, India
Hospital Tengku Ampuan Afzan
🇲🇾Kuantan, Malaysia
King George Government Hospital
🇮🇳Visakhapatnam, Andhra Pradesh, India
Vintage Plaza Nephroplus, Road no. 10, Banjara Hills
🇮🇳Hyderabad, Telangana, India
Neyveli Lignite Corporation Hospital
🇮🇳Neyveli, Tamilnadu, India
Hospital Raja Perempuan Zainab II
🇲🇾Kota Bharu, Malaysia
Hospital Pakar Sultanah Fatimah
🇲🇾Muar, Malaysia
Janak Dulari Hospital, Hanuman Nagar
🇮🇳Patna, Bihar, India
Citizens Specialty Hospital
🇮🇳Hyderabad, Telangana, India
Hitwardhak Mandal Hospital
🇮🇳Mumbai, Maharashtra, India
Hospital Seberang Jaya
🇲🇾Permatang Pauh, Malaysia
Hospital Sultan Abdul Halim
🇲🇾Sungai Petani, Malaysia
Hospital Sultan Haji Ahmad Shah
🇲🇾Temerluh, Malaysia
Jyothi Hospital
🇮🇳Balasore, Odisha, India
Satguru Partap Singh Apollo Hospitals
🇮🇳Ludhiāna, Punjab, India
Deepam Hospitals, Pallavaram
🇮🇳Chennai, Tamilnadu, India
ESI Multi-Specialty Hospital
🇮🇳Hyderabad, Telangana, India
Universiti Kebangsaan Malaysia Medical Centre
🇲🇾Kuala Lumpur, Malaysia
Hospital Shah Alam
🇲🇾Shah Alam, Malaysia
Hospital Tambunan
🇲🇾Tambunan, Malaysia
Hospital Kudat
🇲🇾Kudat, Malaysia
Pusat Dialisis NKF - Chempaka
🇲🇾Petaling Jaya, Malaysia
Hospital Sungai Siput
🇲🇾Sungai Siput, Malaysia
Margate Renal Unit
🇬🇧Margate, United Kingdom
Royal Adelaide Hospital
🇦🇺Adelaide, Australia
Flinders Medical Centre
🇦🇺Bedford Park, Australia
Moorabbin Hospital
🇦🇺Bentleigh East, Australia
Princess Alexandra Hospital
🇦🇺Brisbane, Australia
Bundaberg Hospital
🇦🇺Bundaberg, Australia
Redlands Hospital
🇦🇺Brisbane, Australia
Caloundra Hospital
🇦🇺Caloundra, Australia
Royal Prince Alfred Hospital
🇦🇺Camperdown, Australia
Peninsula Health
🇦🇺Frankston, Australia
The Canberra Hospital
🇦🇺Canberra, Australia
Gympie Hospital
🇦🇺Gympie, Australia
Mackay Base Hospital
🇦🇺Mackay, Australia
Ipswich Hospital
🇦🇺Ipswich, Australia
Hervey Bay Hospital
🇦🇺Pialba, Australia
Casey Hospital
🇦🇺Melbourne, Australia
Cranbourne Integrated Care Centre
🇦🇺Melbourne, Australia
Logan Hospital
🇦🇺Meadowbrook, Australia
Monash Health Community Dandenong
🇦🇺Melbourne, Australia
Nambour General Hospital
🇦🇺Nambour, Australia
Royal North Shore Hospital
🇦🇺St Leonards, Australia
Sunshine Coast University Hospital
🇦🇺Sunshine Coast, Australia
Hampstead Dialysis Centre
🇦🇺Northfield, Australia
Concord Repatriation and General Hospital
🇦🇺Sydney, Australia
Sydney Adventist Hospital
🇦🇺Sydney, Australia
St Joseph's Healthcare
🇨🇦Hamilton, Ontario, Canada
Mt Druitt Community Dialysis Centre
🇦🇺Sydney, Australia
Blacktown Regional Dialysis Centre
🇦🇺Sydney, Australia
Westmead Hospital
🇦🇺Sydney, Australia
Nepean Hospital
🇦🇺Sydney, Australia
The Queen Elizabeth Hospital
🇦🇺Woodville South, Australia
Brantford General Hospital
🇨🇦Brantford, Ontario, Canada
Chatam-Kent Health Alliance
🇨🇦Chatham, Ontario, Canada
Adam Linton Dialysis Unit - Victoria Hospital
🇨🇦London, Ontario, Canada
Hanover District Hospital
🇨🇦Hanover, Ontario, Canada
Westmount Kidney Care Centre
🇨🇦London, Ontario, Canada
London Health Sciences Centre
🇨🇦London, Ontario, Canada
Grey Bruce Health Services
🇨🇦Owen Sound, Ontario, Canada
Huron Perth Hospital Partnership
🇨🇦Stratford, Ontario, Canada
Tillsonburg District Memorial Hospital
🇨🇦Tillsonburg, Ontario, Canada
Stoney Creek
🇨🇦Hamilton, Canada
Bluewater Hospital
🇨🇦Sarnia, Ontario, Canada
Woodstock General Hospital
🇨🇦Woodstock, Ontario, Canada
Belleville
🇨🇦Kingston, Canada
Brockville
🇨🇦Kingston, Canada
Perth and Smith Falls
🇨🇦Kingston, Canada
Napanee
🇨🇦Kingston, Canada
St. Michael's Hospital
🇨🇦Toronto, Canada
Dialyse am Kortumpark Bochum
🇩🇪Bochum, Germany
Nephrologisches Zentrum Albstadt
🇩🇪Albstadt, Germany
Picton
🇨🇦Kingston, Canada
Praxis für Nierenkrankheiten Berlin Hellersdorf
🇩🇪Berlin, Germany
Dialysezentrum Darmstadt
🇩🇪Darmstadt, Germany
Nephrologisches Zentrum Hechingen
🇩🇪Hechingen, Germany
Dialysezentrum Elsenfeld
🇩🇪Elsenfeld, Germany
Arbeitsgemeinschaft Heimdialyse Saar e.V.
🇩🇪Homburg, Germany
Dialysezentrum Langen
🇩🇪Langen, Germany
Kingston General
🇨🇦Kingston, Canada
Dialysezentrum Schweinfurt
🇩🇪Schweinfurt, Germany
KfH Nierenzentrum München Schwabing
🇩🇪Munich, Germany
Universitätsmedizin Mainz, Dialysestation 605-5E
🇩🇪Mainz, Germany
Dialysezentrum Siegburg
🇩🇪Siegburg, Germany
Nephrologisches Zentrum Villingen-Schwenningen -Tuttlingen
🇩🇪Villingen-Schwenningen, Germany
Nephrologie - Dialyse - Christliches Klinikum Unna
🇩🇪Unna, Germany
UBAG Öhringen
🇩🇪Öhringen, Germany
Area Hospital, Kothapeta Road,Chirala, Andhra Pradesh
🇮🇳Chirala, Andhra Pradesh, India
Government Hospital, Machilipatnam PPP, Andhra Pradesh
🇮🇳Machilipatnam, Andhra Pradesh, India
Government Area Hospital
🇮🇳Parvathipuram, Andhra Pradesh, India
Greater Kailash Hospital
🇮🇳Old Palasia, Indore, India
Manasa Kidney Foundation
🇮🇳Tirupati, Andhra Pradesh, India
Rajiv Gandhi Institute of Medical Sciences, Srikakulam PPP, Andhra
🇮🇳Srikakulam, Andhra, India
ESI Hospital
🇮🇳Adityapur, Jharkand, India
Leelawati Hospital
🇮🇳Ambāla, Haryana, India
Asarfi Hospital
🇮🇳Dhanbad, Jharkhand, India
Fortis Suchirayu Hospital
🇮🇳Hubli, Karnataka, India
Guru Nanak Hospital and Research Centre
🇮🇳Ranchi, Jharkhand, India
Koshys Hospital, Ramamurthy Nagar
🇮🇳Bengaluru, Karnataka, India
Bhagwan Mahavir Medical Superspeciality Hospital
🇮🇳Ranchi, Jharkhand, India
Chirayu Hospital
🇮🇳Thāne, Maharashtra, India
Nephroplus Borivali Standalone
🇮🇳Borivali West, Mumbai, India
Kar Clinic & Hospital Pvt. Ltd.
🇮🇳Bhubaneswar, Odisha, India
Neelachal Hospital, Kharvel Nagar
🇮🇳Bhubaneswar, Odisha, India
Nephroplus Standalone Dialysis Center, Easy Marredpally
🇮🇳Secunderabad, Telangana, India
Ajanta Hospital
🇮🇳Lucknow, Uttar Pradesh, India
Pusat Dialisis NKF- Yayasan Dialisis Pendidikan Akhlak Perak
🇲🇾Ipoh, Malaysia
Minimal Access Surgery Clinic Pvt Ltd
🇮🇳Tamluk, West Bengal, India
Hospital Sultanah Nora Ismail
🇲🇾Batu Pahat, Malaysia
Baroma Sirona Hospital
🇮🇳Uttar Mechgram, West Bengal, India
Hospital Beaufort
🇲🇾Beaufort, Malaysia
Hospital Pulau Pinang
🇲🇾George Town, Malaysia
Hospital Ampang
🇲🇾Ampang, Malaysia
Hospital Sultan Ismail
🇲🇾Johor Bahru, Malaysia
Hospital Tuanku Fauziah
🇲🇾Kangar, Malaysia
Hospital Serdang
🇲🇾Kajang, Malaysia
Pusat Rawatan Dialisis Tuanku Syed Putra - NKF
🇲🇾Kangar, Malaysia
Hospital Queen Elizabeth II
🇲🇾Kota Kinabalu, Malaysia
Hospital Likas
🇲🇾Kota Kinabalu, Malaysia
Hospital Kuala Kangsar
🇲🇾Kuala Kangsar, Malaysia
Hospital Kuala Lipis
🇲🇾Kuala Lipis, Malaysia
Pusat Dialisis NKF-Fungates Superflow
🇲🇾Kuala Lumpur, Malaysia
Hospital Kuala Lumpur
🇲🇾Kuala Lumpur, Malaysia
University of Malaya Medical Centre
🇲🇾Kuala Lumpur, Malaysia
Pusat Dialisis NKF-Nanyang
🇲🇾Kuala Lumpur, Malaysia
Hospital Labuan
🇲🇾Labuan, Malaysia
Hospital Kulim
🇲🇾Kulim, Malaysia
Hospital Sultanah Bahiyah
🇲🇾Langgar, Malaysia
Pusat Hemodialisis Komuniti Cheng
🇲🇾Malaka, Malaysia
Universiti Teknologi Mara
🇲🇾Shah Alam, Malaysia
Tameside Renal Dialysis Unit
🇬🇧Ashton-under-Lyne, United Kingdom
Altrincham General Hospital Dialysis Unit
🇬🇧Altrincham, United Kingdom
Barnet Satellite Unit
🇬🇧Barnet, United Kingdom
Barnsley Dialysis Unit
🇬🇧Barnsley, United Kingdom
Bolton Kidney Care Centre
🇬🇧Bolton, United Kingdom
Bath Dialysis Unit
🇬🇧Bath, United Kingdom
St Luke's Hospital Renal Ward
🇬🇧Bradford, United Kingdom
Bexhill Dialysis Unit
🇬🇧Bexhill-on-Sea, United Kingdom
Bedford Renal Unit
🇬🇧Bedford, United Kingdom
Hexagon Towers Dialysis Unit
🇬🇧Blackley, United Kingdom
Bridgwater Dialysis Unit
🇬🇧Bridgwater, United Kingdom
Bromley Dialysis Unit
🇬🇧Bromley, United Kingdom
Cossham Dialysis Unit
🇬🇧Bristol, United Kingdom
Brighton Sussex Kidney Unit
🇬🇧Brighton, United Kingdom
Broomfield Hospital
🇬🇧Broomfield, United Kingdom
South Bristol Dialysis Unit
🇬🇧Bristol, United Kingdom
Cannock Haemodialysis Unit
🇬🇧Cannock, United Kingdom
Clay Lane
🇬🇧Coventry, United Kingdom
Clacton (Diaverum)
🇬🇧Clacton-on-Sea, United Kingdom
Chesterfield Dialysis Unit
🇬🇧Chesterfield, United Kingdom
Colchester (Diaverum)
🇬🇧Colchester, United Kingdom
Leighton
🇬🇧Crewe, United Kingdom
University Hospitals Coventry & Warwickshire Main Unit
🇬🇧Coventry, United Kingdom
Crawley Dialysis Unit
🇬🇧Crawley, United Kingdom
Cromer Hospital Dialysis Unit
🇬🇧Cromer, United Kingdom
Darlington Dialysis Unit
🇬🇧Darlington, United Kingdom
Dartford Dialysis Unit
🇬🇧Dartford, United Kingdom
Edgware Satellite Unit
🇬🇧Edgware, United Kingdom
Dover Renal Unit
🇬🇧Dover, United Kingdom
Epsom Dialysis Unit
🇬🇧Epsom, United Kingdom
Heavitree
🇬🇧Exeter, United Kingdom
Farnborough Dialysis Unit
🇬🇧Farnborough, United Kingdom
Severn
🇬🇧Gloucester, United Kingdom
Cotswold Dialysis Centre
🇬🇧Gloucester, United Kingdom
James Paget Renal Unit
🇬🇧Great Yarmouth, United Kingdom
Grimsby Renal Unit
🇬🇧Grimsby, United Kingdom
Honiton
🇬🇧Honiton, United Kingdom
Harlow Renal Unit
🇬🇧Harlow, United Kingdom
Fresenius Hull Dialysis Unit
🇬🇧Hull, United Kingdom
Hayes Hospital
🇬🇧Hayes, United Kingdom
Collierswood Dialysis Unit
🇬🇧London, United Kingdom
Kingston Satellite Dialysis Unit
🇬🇧Kingston, United Kingdom
West Middlesex
🇬🇧Isleworth, United Kingdom
Royal London Hospital
🇬🇧London, United Kingdom
King George Hospital
🇬🇧London, United Kingdom
North Wandsworth Dialysis Unit
🇬🇧London, United Kingdom
Macclesfield District General Hospital
🇬🇧Macclesfield, United Kingdom
Ludlow Dialysis Unit
🇬🇧Ludlow, United Kingdom
Mary Rankin Satellite Unit
🇬🇧London, United Kingdom
Whipps Cross Hospital
🇬🇧London, United Kingdom
Manchester Royal Infirmary Renal Dialysis Unit
🇬🇧Manchester, United Kingdom
Harrogate
🇬🇧North Yorkshire, United Kingdom
James Cook
🇬🇧Middlesbrough, United Kingdom
North Ormesby
🇬🇧Middlesbrough, United Kingdom
Friarage Hospital
🇬🇧Northallerton, United Kingdom
Lucy Deane (George Eliot)
🇬🇧Nuneaton, United Kingdom
Eastbourne (Polegate) Dialysis Unit
🇬🇧Polegate, United Kingdom
Newham Hospital
🇬🇧Plaistow, United Kingdom
Queen's Hospital
🇬🇧Romford, United Kingdom
Salford Renal Unit
🇬🇧Salford, United Kingdom
Rochdale Dialysis Unit
🇬🇧Rochdale, United Kingdom
Rotherham Dialysis Unit
🇬🇧Rotherham, United Kingdom
St Cross (Ash Unit)
🇬🇧Rugby, United Kingdom
Scarborough
🇬🇧Scarborough, United Kingdom
Renal G Floor
🇬🇧Sheffield, United Kingdom
Scunthorpe Dialysis Centre
🇬🇧Scunthorpe, United Kingdom
Peter Moorhead Unit
🇬🇧Sheffield, United Kingdom
Sheffield Dialysis Unit
🇬🇧Sheffield, United Kingdom
Shrewsbury Renal Unit
🇬🇧Shrewsbury, United Kingdom
St Albans Dialysis Unit
🇬🇧St Albans, United Kingdom
Smethwick Dialysis Centre
🇬🇧Smethwick, United Kingdom
Lister Renal Unit
🇬🇧Stevenage, United Kingdom
County Hospital
🇬🇧Stafford, United Kingdom
Stockport NHS Dialysis Unit
🇬🇧Stockport, United Kingdom
Royal Stoke
🇬🇧Stoke-on-Trent, United Kingdom
North Tees
🇬🇧Stockton-on-Tees, United Kingdom
Stratford Dialysis Centre
🇬🇧Stratford-upon-Avon, United Kingdom
St. Helier Dialysis Unit
🇬🇧Sutton, United Kingdom
Sutton Dialysis Unit
🇬🇧Sutton, United Kingdom
Croydon Dialysis Unit
🇬🇧Thornton Heath, United Kingdom
Hollinswood House Renal Unit
🇬🇧Telford, United Kingdom
South Devon Satellite Kidney Unit
🇬🇧Torquay, United Kingdom
Taunton Dialysis Centre
🇬🇧Taunton, United Kingdom
Tottenham Hale Satellite Unit
🇬🇧Tottenham, United Kingdom
Ashford Renal Unit
🇬🇧Willesborough, United Kingdom
Wigan Renal Unit
🇬🇧Wigan, United Kingdom
Woolwich Dialysis Unit
🇬🇧Woolwich, United Kingdom
Pond Lane Dialysis Unit
🇬🇧Wolverhampton, United Kingdom
Easingwold
🇬🇧York, United Kingdom
Worthing Dialysis Unit
🇬🇧Worthing, United Kingdom
York Hospital
🇬🇧York, United Kingdom
Madhuraj Hospital
🇮🇳Kanpur, Uttar Pradesh, India
Vishesh Hospital Pvt. Ltd, Geeta Bhawan Chouraha
🇮🇳Indore, Madhya Pradesh, India
Health Point Hospital, Prannth Pandit Street
🇮🇳Kolkata, West Bengal, India
Nephroplus Basaveshwaranagar
🇮🇳Bengaluru, Karnataka, India
Lokmanya Hospital
🇮🇳Pune, Maharashtra, India
CHC Government Hospital
🇮🇳Palasa, Andhra Pradesh, India
Government Area Hospital, Kanigiri, Andhra Pradesh
🇮🇳Kanigiri, Andhra Pradesh, India