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Randomised Evaluation of Sodium Dialysate Levels on Vascular Events (RESOLVE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02823821
Recruitment Status : Recruiting
First Posted : July 6, 2016
Last Update Posted : March 16, 2022
Sponsor:
Collaborators:
Australasian Kidney Trials Network
Australia & New Zealand Dialysis & Transplant Registry
The George Institute for Global Health, India
The George Institute for Global Health, China
Peking University People's Hospital
Institute for Clinical Evaluative Sciences
St. Michaels Hospital
University of Wuerzburg
Malaysian Society of Nephrology
Malaysian Renal Registry
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
End-Stage Kidney Disease Other: Default dialysate sodium concentration of 137mmol/l Other: Default dialysate sodium concentration of 140mmol/l Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Randomised Evaluation of Sodium Dialysate Levels on Vascular Events
Actual Study Start Date : June 2016
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 137mmol/l
Participating dialysis sites will be randomised to a default dialysate sodium concentration of 137mmol/l
Other: 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
Other: 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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02823821


Contacts
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Contact: Nuria Zamora Solano nuria.zamora@sydney.edu.au
Contact: Erika Dempsey erika.dempsey@sydney.edu.au

Locations
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Australia
Royal Adelaide Hospital Recruiting
Adelaide, Australia
Auburn Hospital Recruiting
Auburn, Australia, 2144
Moorabbin Hospital Recruiting
Bentleigh East, Australia, 3165
Princess Alexandra Hospital Recruiting
Brisbane, Australia, 4102
Redlands Hospital Recruiting
Brisbane, Australia, 4163
Bundaberg Hospital Recruiting
Bundaberg, Australia
Caloundra Hospital Recruiting
Caloundra, Australia, 4551
The Canberra Hospital Recruiting
Canberra, Australia
Peninsula Health Recruiting
Frankston, Australia, 3199
Gympie Hospital Recruiting
Gympie, Australia, 4570
Ipswich Hospital Recruiting
Ipswich, Australia, 4305
Mackay Base Hospital Recruiting
Mackay, Australia
Logan Hospital Recruiting
Meadowbrook, Australia, 4131
Monash Health Community Dandenong Recruiting
Melbourne, Australia, 3175
Casey Hospital Recruiting
Melbourne, Australia, 3806
Cranbourne Integrated Care Centre Recruiting
Melbourne, Australia, 3977
Nambour General Hospital Recruiting
Nambour, Australia, 4560
Hampstead Dialysis Centre Recruiting
Northfield, Australia
Hervey Bay Hospital Recruiting
Pialba, Australia
Sunshine Coast University Hospital Recruiting
Sunshine Coast, Australia, 4575
Sydney Adventist Hospital Recruiting
Sydney, Australia, 2076
Concord Repatriation and General Hospital Recruiting
Sydney, Australia, 2139
Blacktown Regional Dialysis Centre Recruiting
Sydney, Australia, 2148
Mt Druitt Community Dialysis Centre Recruiting
Sydney, Australia, 2770
Nepean Hospital Recruiting
Sydney, Australia
Westmead Hospital Recruiting
Sydney, Australia
The Queen Elizabeth Hospital Recruiting
Woodville South, Australia
Canada, Ontario
Brantford General Hospital Recruiting
Brantford, Ontario, Canada
Chatam-Kent Health Alliance Recruiting
Chatham, Ontario, Canada
St Joseph's Healthcare Recruiting
Hamilton, Ontario, Canada
Hanover District Hospital Recruiting
Hanover, Ontario, Canada
Adam Linton Dialysis Unit - Victoria Hospital Recruiting
London, Ontario, Canada
London Health Sciences Centre Recruiting
London, Ontario, Canada
Westmount Kidney Care Centre Recruiting
London, Ontario, Canada
Grey Bruce Health Services Recruiting
Owen Sound, Ontario, Canada
Bluewater Hospital Recruiting
Sarnia, Ontario, Canada
Huron Perth Hospital Partnership Recruiting
Stratford, Ontario, Canada
Tillsonburg District Memorial Hospital Recruiting
Tillsonburg, Ontario, Canada
Woodstock General Hospital Recruiting
Woodstock, Ontario, Canada
Canada
Stoney Creek Recruiting
Hamilton, Canada
Belleville Recruiting
Kingston, Canada
Brockville Recruiting
Kingston, Canada
Kingston General Recruiting
Kingston, Canada
Napanee Recruiting
Kingston, Canada
Perth and Smith Falls Recruiting
Kingston, Canada
Picton Recruiting
Kingston, Canada
St. Michael's Hospital Recruiting
Toronto, Canada
Germany
Praxis für Nierenkrankheiten Berlin Hellersdorf Recruiting
Berlin, Germany
Dialysezentrum Elsenfeld Recruiting
Elsenfeld, Germany
Arbeitsgemeinschaft Heimdialyse Saar e.V. Recruiting
Homburg, Germany
KfH Nierenzentrum Lichtenfels Recruiting
Lichtenfels, Germany
Universitätsmedizin Mainz, Dialysestation 605-5E Recruiting
Mainz, Germany
Dialysezentrum Schweinfurt Recruiting
Schweinfurt, Germany
Nephrologisches Zentrum Villingen-Schwenningen -Tuttlingen Recruiting
Villingen-Schwenningen, Germany, 78052
India
Area Hospital, Kothapeta Road,Chirala, Andhra Pradesh Recruiting
Chirala, Andhra Pradesh, India
Medical Superintendent Government Hospital Recruiting
Gudur, Andhra Pradesh, India
Government General Hospital Recruiting
Guntur, Andhra Pradesh, India
Medical Superintendent District Hospital Recruiting
Hindupur PPP, Andhra Pradesh, India
Government Area Hospital, Kanigiri, Andhra Pradesh Recruiting
Kanigiri, Andhra Pradesh, India
Government General Hospital Recruiting
Kurnool, Andhra Pradesh, India
Government Hospital Recruiting
Kākināda, Andhra Pradesh, India
Government Hospital, Machilipatnam PPP, Andhra Pradesh Recruiting
Machilipatnam, Andhra Pradesh, India
Government Area Hospital Recruiting
Markapur, Andhra Pradesh, India
Government Hospital Recruiting
Nandyal, Andhra Pradesh, India
Area Hospital Recruiting
Narsipatnam, Andhra Pradesh, India
Government Area Hospital Recruiting
Palakonda, Srikakulam District, Andhra Pradesh, India
CHC Government Hospital Recruiting
Palasa, Andhra Pradesh, India
Government Area Hospital Recruiting
Parvathipuram, Andhra Pradesh, India
Government Hospital Recruiting
Proddatur, Andhra Pradesh, India
Government Hospital Recruiting
Rajahmundry, Andhra Pradesh, India
CHC Hospital, Sompeta, Andhra Pradesh Recruiting
Sompeta, Andhra Pradesh, India
Greater Kailash Hospital Recruiting
Tadepalligudem, Andhra Pradesh, India
Manasa Kidney Foundation Recruiting
Tirupati, Andhra Pradesh, India
Government General Hospital, Vijayavada PPP, Andhra Pradesh Recruiting
Vijayavada, Andhra Pradesh, India
King George Government Hospital Recruiting
Visakhapatnam, Andhra Pradesh, India
Rajiv Gandhi Institute of Medical Sciences, Srikakulam PPP, Andhra Recruiting
Srikakulam, Andhra, India
Ford Hospital, Khemnichak, Patna Recruiting
Patna, Bihar, India
Janak Dulari Hospital, Hanuman Nagar Recruiting
Patna, Bihar, India
Aysha Hospital Recruiting
Kilpauk, Chennai, India
Retteri Sri Kumaran Health Centre Recruiting
Kolathur, Chennai, India
Leelawati Hospital Recruiting
Ambāla, Haryana, India
Greater Kailash Hospital Recruiting
Old Palasia, Indore, India
ESI Hospital Recruiting
Adityapur, Jharkand, India
K.M Memorial Hospital and Research Centre Recruiting
Bokaro, Jharkhand, India
Asarfi Hospital Recruiting
Dhanbad, Jharkhand, India
Bhagwan Mahavir Medical Superspeciality Hospital Recruiting
Ranchi, Jharkhand, India
Guru Nanak Hospital and Research Centre Recruiting
Ranchi, Jharkhand, India
Koshys Hospital, Ramamurthy Nagar Recruiting
Bengaluru, Karnataka, India
Nephroplus Basaveshwaranagar Recruiting
Bengaluru, Karnataka, India
Fortis Suchirayu Hospital Recruiting
Hubli, Karnataka, India
Main Hospital, SCCL Recruiting
Kothagudem, Khammam, India
Vishesh Hospital Pvt. Ltd, Geeta Bhawan Chouraha Recruiting
Indore, Madhya Pradesh, India
Hitwardhak Mandal Hospital Recruiting
Mumbai, Maharashtra, India
Contact: Kamal D Shah         
Contact: Abhinav Bassi         
Lokmanya Hospital Recruiting
Pune, Maharashtra, India
Chirayu Hospital Recruiting
Thāne, Maharashtra, India
Nephroplus Borivali Standalone Recruiting
Borivali West, Mumbai, India, 400092
Contact: Kamal D Shah         
Contact: Abhinav Bassi         
Bharat Baug Recruiting
Borivali West, Mumbai, India
Jyothi Hospital Recruiting
Balasore, Odisha, India
Kar Clinic & Hospital Pvt. Ltd. Recruiting
Bhubaneswar, Odisha, India
Neelachal Hospital, Kharvel Nagar Recruiting
Bhubaneswar, Odisha, India
Satguru Partap Singh Apollo Hospitals Recruiting
Ludhiāna, Punjab, India
KG Hospital Recruiting
Coimbatore, Tamil Nadu, India
Sudha Hospital, Vadalur Recruiting
Neyveli, Tamil Nadu, India
Deepam Hospitals, Pallavaram Recruiting
Chennai, Tamilnadu, India
Neyveli Lignite Corporation Hospital Recruiting
Neyveli, Tamilnadu, India
Citizens Specialty Hospital Recruiting
Hyderabad, Telangana, India
ESI Multi-Specialty Hospital Recruiting
Hyderabad, Telangana, India
Vintage Plaza Nephroplus, Road no. 10, Banjara Hills Recruiting
Hyderabad, Telangana, India
Government Hospital Recruiting
Khammam, Telangana, India
Suraksha Multispecialty Hospital Recruiting
Nalgonda, Telangana, India
Nephroplus Standalone Dialysis Center, Easy Marredpally Recruiting
Secunderabad, Telangana, India
Madhuraj Hospital Recruiting
Kanpur, Uttar Pradesh, India
Ajanta Hospital Recruiting
Lucknow, Uttar Pradesh, India
Surbhi Hospital Pvt. Ltd, Sector 35 Recruiting
Noida, Uttar Pradish, India
Health Point Hospital, Prannth Pandit Street Recruiting
Kolkata, West Bengal, India
Minimal Access Surgery Clinic Pvt Ltd Recruiting
Tamluk, West Bengal, India
Baroma Sirona Hospital Recruiting
Uttar Mechgram, West Bengal, India
Sponsors and Collaborators
University of Sydney
Australasian Kidney Trials Network
Australia & New Zealand Dialysis & Transplant Registry
The George Institute for Global Health, India
The George Institute for Global Health, China
Peking University People's Hospital
Institute for Clinical Evaluative Sciences
St. Michaels Hospital
University of Wuerzburg
Malaysian Society of Nephrology
Malaysian Renal Registry
Investigators
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Principal Investigator: 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: David Wheeler University College, London
Study Chair: Patrick Rossignol INSERM Clinical Investigation Centre
Study Chair: Mike Walsh McMaster University
Study Chair: Mark Marshall University of Auckland, New Zealand
Study Chair: Vlado Perkovic University of New South Wales
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Sydney
ClinicalTrials.gov Identifier: NCT02823821    
Other Study ID Numbers: GI-AU-RM-2016-01
First Posted: July 6, 2016    Key Record Dates
Last Update Posted: March 16, 2022
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Sydney:
End-Stage Kidney Disease
Hemodialysis
Dialysate
Sodium
Cluster-randomisation
Dialysis
RESOLVE
Additional relevant MeSH terms:
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Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Dialysis Solutions
Pharmaceutical Solutions