Randomised Evaluation of Sodium Dialysate Levels on Vascular Events (RESOLVE)
April 1, 2025 updated by: University of Sydney
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.
Study Overview
Status
Recruiting
Conditions
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.
Study Type
Interventional
Enrollment (Estimated)
50000
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Erika Dempsey
- Email: erika.dempsey@sydney.edu.au
Study Contact Backup
- Name: Grace Balicki
- Email: grace.balicki@sydney.edu.au
Study Locations
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Adelaide, Australia
- Recruiting
- Royal Adelaide Hospital
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Auburn, Australia, 2144
- Recruiting
- Auburn Hospital
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Bedford Park, Australia
- Recruiting
- Flinders Medical Centre
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Bentleigh East, Australia, 3165
- Recruiting
- Moorabbin Hospital
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Birtinya, Australia
- Recruiting
- Sunshine Coast University Private Hospital
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Brisbane, Australia, 4102
- Recruiting
- Princess Alexandra Hospital
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Brisbane, Australia, 4163
- Recruiting
- Redlands Hospital
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Bundaberg, Australia
- Recruiting
- Bundaberg Hospital
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Caloundra, Australia, 4551
- Recruiting
- Caloundra Hospital
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Camperdown, Australia
- Recruiting
- Royal Prince Alfred Hospital
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Canberra, Australia
- Recruiting
- The Canberra Hospital
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Frankston, Australia, 3199
- Recruiting
- Peninsula Health
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Gympie, Australia, 4570
- Recruiting
- Gympie Hospital
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Ipswich, Australia, 4305
- Recruiting
- Ipswich Hospital
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Mackay, Australia
- Recruiting
- Mackay Base Hospital
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Meadowbrook, Australia, 4131
- Recruiting
- Logan Hospital
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Melbourne, Australia, 3175
- Recruiting
- Monash Health Community Dandenong
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Melbourne, Australia, 3806
- Recruiting
- Casey Hospital
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Melbourne, Australia, 3977
- Recruiting
- Cranbourne Integrated Care Centre
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Nambour, Australia, 4560
- Recruiting
- Nambour General Hospital
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Northfield, Australia
- Recruiting
- Hampstead Dialysis Centre
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Pialba, Australia
- Recruiting
- Hervey Bay Hospital
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St Leonards, Australia
- Recruiting
- Royal North Shore Hospital
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Sunshine Coast, Australia, 4575
- Recruiting
- Sunshine Coast University Hospital
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Sydney, Australia
- Recruiting
- Westmead Hospital
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Sydney, Australia, 2076
- Recruiting
- Sydney Adventist Hospital
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Sydney, Australia, 2139
- Recruiting
- Concord Repatriation and General Hospital
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Sydney, Australia, 2148
- Recruiting
- Blacktown Regional Dialysis Centre
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Sydney, Australia, 2770
- Recruiting
- Mt Druitt Community Dialysis Centre
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Sydney, Australia
- Recruiting
- Nepean Hospital
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Woodville South, Australia
- Recruiting
- The Queen Elizabeth Hospital
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Hamilton, Canada
- Recruiting
- Stoney Creek
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Kingston, Canada
- Recruiting
- Belleville
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Kingston, Canada
- Recruiting
- Brockville
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Kingston, Canada
- Recruiting
- Kingston General
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Kingston, Canada
- Recruiting
- Napanee
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Kingston, Canada
- Recruiting
- Perth and Smith Falls
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Kingston, Canada
- Recruiting
- Picton
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Toronto, Canada
- Recruiting
- St. Michael's Hospital
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Ontario
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Brantford, Ontario, Canada
- Recruiting
- Brantford General Hospital
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Chatham, Ontario, Canada
- Recruiting
- Chatam-Kent Health Alliance
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Hamilton, Ontario, Canada
- Recruiting
- St Joseph's Healthcare
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Hanover, Ontario, Canada
- Recruiting
- Hanover District Hospital
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London, Ontario, Canada
- Recruiting
- London Health Sciences Centre
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London, Ontario, Canada
- Recruiting
- Adam Linton Dialysis Unit - Victoria Hospital
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London, Ontario, Canada
- Recruiting
- Westmount Kidney Care Centre
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Owen Sound, Ontario, Canada
- Recruiting
- Grey Bruce Health Services
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Sarnia, Ontario, Canada
- Recruiting
- Bluewater Hospital
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Stratford, Ontario, Canada
- Recruiting
- Huron Perth Hospital Partnership
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Tillsonburg, Ontario, Canada
- Recruiting
- Tillsonburg District Memorial Hospital
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Woodstock, Ontario, Canada
- Recruiting
- Woodstock General Hospital
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Albstadt, Germany
- Recruiting
- Nephrologisches Zentrum Albstadt
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Berlin, Germany
- Recruiting
- Praxis für Nierenkrankheiten Berlin Hellersdorf
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Bochum, Germany
- Recruiting
- Dialyse am Kortumpark Bochum
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Darmstadt, Germany
- Recruiting
- Dialysezentrum Darmstadt
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Elsenfeld, Germany
- Recruiting
- Dialysezentrum Elsenfeld
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Hechingen, Germany
- Recruiting
- Nephrologisches Zentrum Hechingen
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Homburg, Germany
- Recruiting
- Arbeitsgemeinschaft Heimdialyse Saar e.V.
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Langen, Germany
- Recruiting
- Dialysezentrum Langen
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Lichtenfels, Germany
- Recruiting
- KfH Nierenzentrum Lichtenfels
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Mainz, Germany
- Recruiting
- Universitätsmedizin Mainz, Dialysestation 605-5E
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Munich, Germany
- Recruiting
- KfH Nierenzentrum München Schwabing
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Schweinfurt, Germany
- Recruiting
- Dialysezentrum Schweinfurt
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Siegburg, Germany
- Recruiting
- Dialysezentrum Siegburg
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Unna, Germany
- Recruiting
- Nephrologie - Dialyse - Christliches Klinikum Unna
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Villingen-Schwenningen, Germany, 78052
- Recruiting
- Nephrologisches Zentrum Villingen-Schwenningen -Tuttlingen
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Öhringen, Germany
- Recruiting
- UBAG Öhringen
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Andhra
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Srikakulam, Andhra, India
- Recruiting
- Rajiv Gandhi Institute of Medical Sciences, Srikakulam PPP, Andhra
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Andhra Pradesh
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Chirala, Andhra Pradesh, India
- Recruiting
- Area Hospital, Kothapeta Road,Chirala, Andhra Pradesh
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Gudur, Andhra Pradesh, India
- Recruiting
- Medical Superintendent Government Hospital
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Guntur, Andhra Pradesh, India
- Recruiting
- Government General Hospital
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Hindupur PPP, Andhra Pradesh, India
- Recruiting
- Medical Superintendent District Hospital
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Kanigiri, Andhra Pradesh, India
- Recruiting
- Government Area Hospital, Kanigiri, Andhra Pradesh
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Kurnool, Andhra Pradesh, India
- Recruiting
- Government General Hospital
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Kākināda, Andhra Pradesh, India
- Recruiting
- Government Hospital
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Machilipatnam, Andhra Pradesh, India
- Recruiting
- Government Hospital, Machilipatnam PPP, Andhra Pradesh
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Markapur, Andhra Pradesh, India
- Recruiting
- Government Area Hospital
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Nandyal, Andhra Pradesh, India
- Recruiting
- Government Hospital
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Narsipatnam, Andhra Pradesh, India
- Recruiting
- Area Hospital
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Palakonda, Srikakulam District, Andhra Pradesh, India
- Recruiting
- Government Area Hospital
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Palasa, Andhra Pradesh, India
- Recruiting
- CHC Government Hospital
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Parvathipuram, Andhra Pradesh, India
- Recruiting
- Government Area Hospital
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Proddatur, Andhra Pradesh, India
- Recruiting
- Government Hospital
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Rajahmundry, Andhra Pradesh, India
- Recruiting
- Government Hospital
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Sompeta, Andhra Pradesh, India
- Recruiting
- CHC Hospital, Sompeta, Andhra Pradesh
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Tadepalligudem, Andhra Pradesh, India
- Recruiting
- Greater Kailash Hospital
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Tirupati, Andhra Pradesh, India
- Recruiting
- Manasa Kidney Foundation
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Vijayavada, Andhra Pradesh, India
- Recruiting
- Government General Hospital, Vijayavada PPP, Andhra Pradesh
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Visakhapatnam, Andhra Pradesh, India
- Recruiting
- King George Government Hospital
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Bihar
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Patna, Bihar, India
- Recruiting
- Ford Hospital, Khemnichak, Patna
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Patna, Bihar, India
- Recruiting
- Janak Dulari Hospital, Hanuman Nagar
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Chennai
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Kilpauk, Chennai, India
- Recruiting
- Aysha Hospital
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Kolathur, Chennai, India
- Recruiting
- Retteri Sri Kumaran Health Centre
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Haryana
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Ambāla, Haryana, India
- Recruiting
- Leelawati Hospital
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Indore
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Old Palasia, Indore, India
- Recruiting
- Greater Kailash Hospital
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Jharkand
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Adityapur, Jharkand, India
- Recruiting
- ESI Hospital
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Jharkhand
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Bokaro, Jharkhand, India
- Recruiting
- K.M Memorial Hospital and Research Centre
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Dhanbad, Jharkhand, India
- Recruiting
- Asarfi Hospital
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Ranchi, Jharkhand, India
- Recruiting
- Bhagwan Mahavir Medical Superspeciality Hospital
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Ranchi, Jharkhand, India
- Recruiting
- Guru Nanak Hospital and Research Centre
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Karnataka
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Bengaluru, Karnataka, India
- Recruiting
- Koshys Hospital, Ramamurthy Nagar
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Bengaluru, Karnataka, India
- Recruiting
- Nephroplus Basaveshwaranagar
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Hubli, Karnataka, India
- Recruiting
- Fortis Suchirayu Hospital
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Khammam
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Kothagudem, Khammam, India
- Recruiting
- Main Hospital, SCCL
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Madhya Pradesh
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Indore, Madhya Pradesh, India
- Recruiting
- Vishesh Hospital Pvt. Ltd, Geeta Bhawan Chouraha
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Maharashtra
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Mumbai, Maharashtra, India
- Recruiting
- Hitwardhak Mandal Hospital
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Contact:
- Kamal D Shah
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Contact:
- Abhinav Bassi
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Pune, Maharashtra, India
- Recruiting
- Lokmanya Hospital
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Thāne, Maharashtra, India
- Recruiting
- Chirayu Hospital
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Mumbai
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Borivali West, Mumbai, India, 400092
- Recruiting
- Nephroplus Borivali Standalone
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Contact:
- Kamal D Shah
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Contact:
- Abhinav Bassi
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Borivali West, Mumbai, India
- Recruiting
- Bharat Baug
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Odisha
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Balasore, Odisha, India
- Recruiting
- Jyothi Hospital
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Bhubaneswar, Odisha, India
- Recruiting
- Kar Clinic & Hospital Pvt. Ltd.
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Bhubaneswar, Odisha, India
- Recruiting
- Neelachal Hospital, Kharvel Nagar
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Punjab
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Ludhiāna, Punjab, India
- Recruiting
- Satguru Partap Singh Apollo Hospitals
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Tamil Nadu
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Coimbatore, Tamil Nadu, India
- Recruiting
- KG Hospital
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Neyveli, Tamil Nadu, India
- Recruiting
- Sudha Hospital, Vadalur
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Tamilnadu
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Chennai, Tamilnadu, India
- Recruiting
- Deepam Hospitals, Pallavaram
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Neyveli, Tamilnadu, India
- Recruiting
- Neyveli Lignite Corporation Hospital
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Telangana
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Hyderabad, Telangana, India
- Recruiting
- Citizens Specialty Hospital
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Hyderabad, Telangana, India
- Recruiting
- ESI Multi-Specialty Hospital
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Hyderabad, Telangana, India
- Recruiting
- Vintage Plaza Nephroplus, Road no. 10, Banjara Hills
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Khammam, Telangana, India
- Recruiting
- Government Hospital
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Nalgonda, Telangana, India
- Recruiting
- Suraksha Multispecialty Hospital
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Secunderabad, Telangana, India
- Recruiting
- Nephroplus Standalone Dialysis Center, Easy Marredpally
-
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Uttar Pradesh
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Kanpur, Uttar Pradesh, India
- Recruiting
- Madhuraj Hospital
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Lucknow, Uttar Pradesh, India
- Recruiting
- Ajanta Hospital
-
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Uttar Pradish
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Noida, Uttar Pradish, India
- Recruiting
- Surbhi Hospital Pvt. Ltd, Sector 35
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West Bengal
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Kolkata, West Bengal, India
- Recruiting
- Health Point Hospital, Prannth Pandit Street
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Tamluk, West Bengal, India
- Recruiting
- Minimal Access Surgery Clinic Pvt Ltd
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Uttar Mechgram, West Bengal, India
- Recruiting
- Baroma Sirona Hospital
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Ampang, Malaysia
- Recruiting
- Hospital Ampang
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Batu Pahat, Malaysia
- Recruiting
- Hospital Sultanah Nora Ismail
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Beaufort, Malaysia
- Recruiting
- Hospital Beaufort
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George Town, Malaysia
- Recruiting
- Hospital Pulau Pinang
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Ipoh, Malaysia
- Recruiting
- Pusat Dialisis NKF- Yayasan Dialisis Pendidikan Akhlak Perak
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Johor Bahru, Malaysia
- Recruiting
- Hospital Sultan Ismail
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Johor Bahru, Malaysia
- Recruiting
- Hospital Sultanah Aminah
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Kajang, Malaysia
- Recruiting
- Hospital Serdang
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Kajang, Malaysia
- Recruiting
- Hospital Kajang
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Kangar, Malaysia
- Completed
- Hospital Tuanku Fauziah
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Kangar, Malaysia
- Recruiting
- Pusat Rawatan Dialisis Tuanku Syed Putra - NKF
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Klang, Malaysia
- Recruiting
- Hospital Tengku Ampuan Rahimah
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Klang, Malaysia
- Recruiting
- Pusat Daillisis NKF - Kelab Apex
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Kota Bharu, Malaysia
- Recruiting
- Hospital Raja Perempuan Zainab II
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Kota Kinabalu, Malaysia
- Recruiting
- Hospital Likas
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Kota Kinabalu, Malaysia
- Recruiting
- Hospital Queen Elizabeth II
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Kuala Kangsar, Malaysia
- Recruiting
- Hospital Kuala Kangsar
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Kuala Lipis, Malaysia
- Recruiting
- Hospital Kuala Lipis
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Kuala Lumpur, Malaysia
- Recruiting
- University of Malaya Medical Centre
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Kuala Lumpur, Malaysia
- Recruiting
- Hospital Kuala Lumpur
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Kuala Lumpur, Malaysia
- Recruiting
- Pusat Dialisis NKF-Fungates Superflow
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Kuala Lumpur, Malaysia
- Recruiting
- Pusat Dialisis NKF-Nanyang
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Kuala Lumpur, Malaysia
- Recruiting
- Universiti Kebangsaan Malaysia Medical Centre
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Kuantan, Malaysia
- Recruiting
- Hospital Tengku Ampuan Afzan
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Kudat, Malaysia
- Recruiting
- Hospital Kudat
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Kulim, Malaysia
- Recruiting
- Hospital Kulim
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Labuan, Malaysia
- Recruiting
- Hospital Labuan
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Langgar, Malaysia
- Recruiting
- Hospital Sultanah Bahiyah
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Lenggong, Malaysia
- Recruiting
- Haemodialysis Unit Klinik Kesihatan Lenggong
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Malaka, Malaysia
- Recruiting
- Pusat Hemodialisis Komuniti Cheng
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Muar, Malaysia
- Recruiting
- Hospital Pakar Sultanah Fatimah
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Permatang Pauh, Malaysia
- Recruiting
- Hospital Seberang Jaya
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Petaling Jaya, Malaysia
- Recruiting
- Pusat Dialisis NKF - Chempaka
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Shah Alam, Malaysia
- Recruiting
- Hospital Shah Alam
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Shah Alam, Malaysia
- Recruiting
- Universiti Teknologi Mara
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Sungai Petani, Malaysia
- Recruiting
- Hospital Sultan Abdul Halim
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Sungai Siput, Malaysia
- Recruiting
- Hospital Sungai Siput
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Tambunan, Malaysia
- Recruiting
- Hospital Tambunan
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Temerluh, Malaysia
- Recruiting
- Hospital Sultan Haji Ahmad Shah
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-
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Altrincham, United Kingdom
- Recruiting
- Altrincham General Hospital Dialysis Unit
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Ashton-under-Lyne, United Kingdom
- Recruiting
- Tameside Renal Dialysis Unit
-
Barnet, United Kingdom
- Recruiting
- Barnet Satellite Unit
-
Barnsley, United Kingdom
- Recruiting
- Barnsley Dialysis Unit
-
Bath, United Kingdom
- Recruiting
- Bath Dialysis Unit
-
Bedford, United Kingdom
- Recruiting
- Bedford Renal Unit
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Bexhill-on-Sea, United Kingdom
- Recruiting
- Bexhill Dialysis Unit
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Blackley, United Kingdom
- Recruiting
- Hexagon Towers Dialysis Unit
-
Bolton, United Kingdom
- Recruiting
- Bolton Kidney Care Centre
-
Bradford, United Kingdom
- Recruiting
- St Luke's Hospital Renal Ward
-
Bridgwater, United Kingdom
- Recruiting
- Bridgwater Dialysis Unit
-
Brighton, United Kingdom
- Recruiting
- Brighton Sussex Kidney Unit
-
Bristol, United Kingdom
- Recruiting
- Cossham Dialysis Unit
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Bristol, United Kingdom
- Recruiting
- South Bristol Dialysis Unit
-
Bromley, United Kingdom
- Recruiting
- Bromley Dialysis Unit
-
Broomfield, United Kingdom
- Recruiting
- Broomfield Hospital
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Cannock, United Kingdom
- Recruiting
- Cannock Haemodialysis Unit
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Chesterfield, United Kingdom
- Recruiting
- Chesterfield Dialysis Unit
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Clacton-on-Sea, United Kingdom
- Recruiting
- Clacton (Diaverum)
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Colchester, United Kingdom
- Recruiting
- Colchester (Diaverum)
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Coventry, United Kingdom
- Recruiting
- Clay Lane
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Coventry, United Kingdom
- Recruiting
- University Hospitals Coventry & Warwickshire Main Unit
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Crawley, United Kingdom
- Recruiting
- Crawley Dialysis Unit
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Crewe, United Kingdom
- Recruiting
- Leighton
-
Cromer, United Kingdom
- Recruiting
- Cromer Hospital Dialysis Unit
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Darlington, United Kingdom
- Recruiting
- Darlington Dialysis Unit
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Dartford, United Kingdom
- Recruiting
- Dartford Dialysis Unit
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Dover, United Kingdom
- Recruiting
- Dover Renal Unit
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Edgware, United Kingdom
- Recruiting
- Edgware Satellite Unit
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Epsom, United Kingdom
- Recruiting
- Epsom Dialysis Unit
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Exeter, United Kingdom
- Recruiting
- Heavitree
-
Farnborough, United Kingdom
- Recruiting
- Farnborough Dialysis Unit
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Gloucester, United Kingdom
- Recruiting
- Cotswold Dialysis Centre
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Gloucester, United Kingdom
- Recruiting
- Severn
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Great Yarmouth, United Kingdom
- Recruiting
- James Paget Renal Unit
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Grimsby, United Kingdom
- Recruiting
- Grimsby Renal Unit
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Harlow, United Kingdom
- Recruiting
- Harlow Renal Unit
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Hayes, United Kingdom
- Recruiting
- Hayes Hospital
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Honiton, United Kingdom
- Recruiting
- Honiton
-
Houghton Regis, United Kingdom
- Recruiting
- Chiltern Renal Unit
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Hull, United Kingdom
- Recruiting
- Fresenius Hull Dialysis Unit
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Isleworth, United Kingdom
- Recruiting
- West Middlesex
-
Kingston, United Kingdom
- Recruiting
- Kingston Satellite Dialysis Unit
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London, United Kingdom
- Recruiting
- Royal London Hospital
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London, United Kingdom
- Recruiting
- Mary Rankin Satellite Unit
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London, United Kingdom
- Recruiting
- King George Hospital
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London, United Kingdom
- Recruiting
- Whipps Cross Hospital
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London, United Kingdom
- Recruiting
- Collierswood Dialysis Unit
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London, United Kingdom
- Recruiting
- North Wandsworth Dialysis Unit
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Ludlow, United Kingdom
- Recruiting
- Ludlow Dialysis Unit
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Macclesfield, United Kingdom
- Recruiting
- Macclesfield District General Hospital
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Manchester, United Kingdom
- Recruiting
- Manchester Royal Infirmary Renal Dialysis Unit
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Manchester, United Kingdom
- Recruiting
- Octagon Renal Satellite
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Margate, United Kingdom
- Recruiting
- Margate Renal Unit
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Middlesbrough, United Kingdom
- Recruiting
- James Cook
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Middlesbrough, United Kingdom
- Recruiting
- North Ormesby
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North Yorkshire, United Kingdom
- Recruiting
- Harrogate
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Northallerton, United Kingdom
- Recruiting
- Friarage Hospital
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Nuneaton, United Kingdom
- Recruiting
- Lucy Deane (George Eliot)
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Oldham, United Kingdom
- Recruiting
- Oldham Dialysis Unit
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Plaistow, United Kingdom
- Recruiting
- Newham Hospital
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Polegate, United Kingdom
- Recruiting
- Eastbourne (Polegate) Dialysis Unit
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Rochdale, United Kingdom
- Recruiting
- Rochdale Dialysis Unit
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Romford, United Kingdom
- Recruiting
- Queen's Hospital
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Rotherham, United Kingdom
- Recruiting
- Rotherham Dialysis Unit
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Rugby, United Kingdom
- Recruiting
- St Cross (Ash Unit)
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Salford, United Kingdom
- Recruiting
- Salford Renal Unit
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Scarborough, United Kingdom
- Recruiting
- Scarborough
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Scunthorpe, United Kingdom
- Recruiting
- Scunthorpe Dialysis Centre
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Sheffield, United Kingdom
- Recruiting
- Renal G Floor
-
Sheffield, United Kingdom
- Recruiting
- Peter Moorhead Unit
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Sheffield, United Kingdom
- Recruiting
- Sheffield Dialysis Unit
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Shrewsbury, United Kingdom
- Recruiting
- Shrewsbury Renal Unit
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Smethwick, United Kingdom
- Recruiting
- Smethwick Dialysis Centre
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St Albans, United Kingdom
- Recruiting
- St Albans Dialysis Unit
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Stafford, United Kingdom
- Recruiting
- County Hospital
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Stevenage, United Kingdom
- Recruiting
- Lister Renal Unit
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Stockport, United Kingdom
- Recruiting
- Stockport NHS Dialysis Unit
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Stockton-on-Tees, United Kingdom
- Recruiting
- North Tees
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Stoke-on-Trent, United Kingdom
- Recruiting
- Royal Stoke
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Stratford-upon-Avon, United Kingdom
- Recruiting
- Stratford Dialysis Centre
-
Sutton, United Kingdom
- Recruiting
- St. Helier Dialysis Unit
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Sutton, United Kingdom
- Recruiting
- Sutton Dialysis Unit
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Taunton, United Kingdom
- Recruiting
- Taunton Dialysis Centre
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Telford, United Kingdom
- Recruiting
- Hollinswood House Renal Unit
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Thornton Heath, United Kingdom
- Recruiting
- Croydon Dialysis Unit
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Torquay, United Kingdom
- Recruiting
- South Devon Satellite Kidney Unit
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Tottenham, United Kingdom
- Recruiting
- Tottenham Hale Satellite Unit
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Wigan, United Kingdom
- Recruiting
- Wigan Renal Unit
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Willesborough, United Kingdom
- Recruiting
- Ashford Renal Unit
-
Wolverhampton, United Kingdom
- Recruiting
- Pond Lane Dialysis Unit
-
Woolwich, United Kingdom
- Recruiting
- Woolwich Dialysis Unit
-
Worthing, United Kingdom
- Recruiting
- Worthing Dialysis Unit
-
York, United Kingdom
- Recruiting
- York Hospital
-
York, United Kingdom
- Recruiting
- Easingwold
-
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 137mmol/l
Participating dialysis sites will be randomised to a default dialysate sodium concentration of 137mmol/l
|
Default defined here as use of allocated dialysate sodium concentration for at least 90% of delivered dialysis sessions.
|
|
Active Comparator: 140mmol/l
Participating dialysis sites will be randomised to a default dialysate sodium concentration of 140mmol/l
|
Default defined here as use of allocated dialysate sodium concentration for at least 90% of delivered dialysis sessions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
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.
|
Through to study completion (estimated to occur after an average of 5 years follow up)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to first occurrence of an event in the secondary composite outcome
Time Frame: 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.
|
Through to study completion (estimated to occur after an average of 5 years follow up)
|
|
Time to first occurrence of each of the individual components of the composite outcomes.
Time Frame: 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.
|
Through to study completion (estimated to occur after an average of 5 years follow up)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Meg Jardine, The University of Sydney, NHMRC Clinical Trials Centre
- Study Chair: Carmel Hawley, The University of Queensland
- Study Chair: Vivekanand Jha, The George Institute India
- Study Chair: Zuo Li, Peking University People's Hospital
- Study Chair: Sunita Bavanandan, Kuala Lumpur General Hospital
- Study Chair: Patrick Rossignol, INSERM Clinical Investigation Centre
- Study Chair: Mike Walsh, McMaster University
- Study Chair: Vlado Perkovic, University of New South Wales
- Study Chair: Christoph Wanner, University Hospital Wuerzburg
- Principal Investigator: Jule Pinter, University Hospital Wuerzburg
- Study Chair: David Wheeler, Comprehensive Clinical Trials Unit, University College London
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2016
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Study Registration Dates
First Submitted
June 16, 2016
First Submitted That Met QC Criteria
July 5, 2016
First Posted (Estimated)
July 6, 2016
Study Record Updates
Last Update Posted (Actual)
April 4, 2025
Last Update Submitted That Met QC Criteria
April 1, 2025
Last Verified
April 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Urogenital Diseases
- Pathologic Processes
- Male Urogenital Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Chronic Disease
- Disease Attributes
- Renal Insufficiency
- Renal Insufficiency, Chronic
- Kidney Diseases
- Kidney Failure, Chronic
- Pharmaceutical Solutions
- Dialysis Solutions
Other Study ID Numbers
- GI-AU-RM-2016-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.