Randomised Evaluation of Sodium Dialysate Levels on Vascular Events
NCT ID: NCT02823821
Last Updated: 2025-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
50000 participants
INTERVENTIONAL
2016-06-30
2026-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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137mmol/l
Participating dialysis sites will be randomised to a default dialysate sodium concentration of 137mmol/l
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.
140mmol/l
Participating dialysis sites will be randomised to a default dialysate sodium concentration of 140mmol/l
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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. \[Sites that include both in-center/satellite dialysis patients and home patients may participate but the study procedures and assessments will only be conducted in the incenter/satellite component of the site\].
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Australasian Kidney Trials Network
NETWORK
Australia & New Zealand Dialysis & Transplant Registry
UNKNOWN
The George Institute
OTHER
The George Institute for Global Health, China
OTHER
Peking University People's Hospital
OTHER
Institute for Clinical Evaluative Sciences
OTHER
St. Michaels Hospital
UNKNOWN
University Hospital Wuerzburg, Medizinische Klinik EINS
UNKNOWN
Malaysian Society of Nephrology
UNKNOWN
Malaysian Renal Registry
UNKNOWN
Comprehensive Clinical Trials Unit, University College London
UNKNOWN
University of Sydney
OTHER
Responsible Party
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Principal Investigators
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Meg Jardine
Role: STUDY_DIRECTOR
The University of Sydney, NHMRC Clinical Trials Centre
Carmel Hawley
Role: STUDY_CHAIR
The University of Queensland
Vivekanand Jha
Role: STUDY_CHAIR
The George Institute India
Zuo Li
Role: STUDY_CHAIR
Peking University People's Hospital
Sunita Bavanandan
Role: STUDY_CHAIR
Kuala Lumpur General Hospital
David Wheeler
Role: STUDY_CHAIR
Comprehensive Clinical Trials Unit, University College London
Patrick Rossignol
Role: STUDY_CHAIR
INSERM Clinical Investigation Centre
Mike Walsh
Role: STUDY_CHAIR
McMaster University
Vlado Perkovic
Role: STUDY_CHAIR
University of New South Wales
Christoph Wanner
Role: STUDY_CHAIR
University Hospital Wuerzburg
Jule Pinter
Role: PRINCIPAL_INVESTIGATOR
University Hospital Wuerzburg
Locations
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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
Tādepallegūdem, 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
Kothagūdem, 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
Thāne, 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
Countries
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Central Contacts
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Facility Contacts
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Kamal D Shah
Role: primary
Abhinav Bassi
Role: backup
Kamal D Shah
Role: primary
Abhinav Bassi
Role: backup
References
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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.
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.
See EJ, Polkinghorne KR. Volume management in haemodialysis patients. Curr Opin Nephrol Hypertens. 2020 Nov;29(6):663-670. doi: 10.1097/MNH.0000000000000642.
Other Identifiers
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GI-AU-RM-2016-01
Identifier Type: -
Identifier Source: org_study_id
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