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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 11, 2020
Sponsor:
Collaborator:
Australasian Kidney Trials Network
Information provided by (Responsible Party):
The George Institute

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 trial 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 2-5 years with average study duration expected to be approximately 5 years. The actual length of the study will be end-point determined.

The study will involve a staged roll-out. The initial Development Phase will ascertain the feasibility of implementing the study protocol. The vanguard phase will continue to implement the protocol and allow testing of study assumptions. The main phase will conclude the study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 51520 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
Study Start Date : June 2016
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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: Erika Dempsey edempsey@georgeinstitute.org.au

Locations
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Australia, Australian Capital Territory
The Canberra Hospital Recruiting
Canberra, Australian Capital Territory, Australia
Contact: Giles Walters         
Australia, New South Wales
Auburn Hospital Recruiting
Auburn, New South Wales, Australia, 2144
Contact: Grahame Elder         
Sydney Adventist Hospital Recruiting
Sydney, New South Wales, Australia, 2076
Contact: Muh Geot Wong         
Contact: Anna Heath         
Concord Repatriation and General Hospital Recruiting
Sydney, New South Wales, Australia, 2139
Contact: Shaundeep Sen         
Contact: Samantha Hand         
Blacktown Regional Dialysis Centre Recruiting
Sydney, New South Wales, Australia
Contact: Lukas Kairaitis         
Mt Druitt Community Dialysis Centre Recruiting
Sydney, New South Wales, Australia
Contact: Lukas Kairaitis         
Nepean Hospital Recruiting
Sydney, New South Wales, Australia
Contact: Kamal Sud         
Westmead Hospital Recruiting
Sydney, New South Wales, Australia
Contact: Vincent Lee         
Australia, Queensland
Princess Alexandra Hospital Recruiting
Brisbane, Queensland, Australia, 4102
Contact: Magid A Fahim         
Redlands Hospital Recruiting
Brisbane, Queensland, Australia, 4163
Contact: David Mudge         
Bundaberg Hospital Recruiting
Bundaberg, Queensland, Australia
Contact: Clyson Mutatiri         
Caloundra Hospital Recruiting
Caloundra, Queensland, Australia, 4551
Contact: Nick Gray         
Gympie Hospital Recruiting
Gympie, Queensland, Australia, 4570
Contact: Nick Gray, MBBS         
Contact: Andrew Pollock         
Ipswich Hospital Recruiting
Ipswich, Queensland, Australia, 4305
Contact: Carolyn Van Eps         
Mackay Base Hospital Recruiting
Mackay, Queensland, Australia
Contact: Roy Cherian         
Logan Hospital Recruiting
Meadowbrook, Queensland, Australia, 4131
Contact: Magid A Fahim         
Nambour General Hospital Recruiting
Nambour, Queensland, Australia, 4560
Contact: Andrew Pollock, MBBS         
Hervey Bay Hospital Recruiting
Pialba, Queensland, Australia
Contact: Krishan Madhan         
Sunshine Coast University Hospital Recruiting
Sunshine Coast, Queensland, Australia, 4575
Contact: Nick Gray         
Contact: Andrew Pollock         
Australia, South Australia
Royal Adelaide Hospital Recruiting
Adelaide, South Australia, Australia
Contact: Phil Clayton         
Hampstead Dialysis Centre Recruiting
Northfield, South Australia, Australia
Contact: Phil Clayton         
The Queen Elizabeth Hospital Recruiting
Woodville South, South Australia, Australia
Contact: Phil Clayton         
Australia, Victoria
Moorabbin Hospital Recruiting
Bentleigh East, Victoria, Australia, 3165
Contact: Peter Kerr         
Peninsula Health Recruiting
Frankston, Victoria, Australia, 3199
Contact: Kim Wong         
Monash Health Community Dandenong Recruiting
Melbourne, Victoria, Australia, 3175
Contact: Peter Kerr         
Contact: Jane Crossett         
Casey Hospital Recruiting
Melbourne, Victoria, Australia, 3806
Contact: Peter Kerr         
Contact: Eileen McDonald         
Cranbourne Integrated Care Centre Recruiting
Melbourne, Victoria, Australia, 3977
Contact: Peter Kerr         
Contact: Fiona Trimble         
Canada, Ontario
Brantford General Hospital Recruiting
Brantford, Ontario, Canada
Contact: Mike Walsh         
Chatam-Kent Health Alliance Recruiting
Chatham, Ontario, Canada
Contact: Amit Garg         
St Joseph's Healthcare Recruiting
Hamilton, Ontario, Canada
Contact: Michael Walsh, MBBS         
Hanover District Hospital Recruiting
Hanover, Ontario, Canada
Contact: Amit Garg         
Adam Linton Dialysis Unit - Victoria Hospital Recruiting
London, Ontario, Canada
Contact: Amit Garg         
London Health Sciences Centre Recruiting
London, Ontario, Canada
Contact: Amit Garg         
Westmount Kidney Care Centre Recruiting
London, Ontario, Canada
Contact: Amit Garg         
Grey Bruce Health Services Recruiting
Owen Sound, Ontario, Canada
Contact: Amit Garg         
Bluewater Hospital Recruiting
Sarnia, Ontario, Canada
Contact: Amit Garg         
Huron Perth Hospital Partnership Recruiting
Stratford, Ontario, Canada
Contact: Amit Garg         
Tillsonburg District Memorial Hospital Recruiting
Tillsonburg, Ontario, Canada
Contact: Amit Garg         
Woodstock General Hospital Recruiting
Woodstock, Ontario, Canada
Contact: Amit Garg         
China, Beijing Shi
Aerospace Central Hospital Recruiting
Haidian Qu, Beijing Shi, China
Contact: Songtao Yang         
China, Beijing
China Rehabilitation Research Center Recruiting
Fengtai, Beijing, China
Contact: Yichun Ma         
China, Hainan
Chinese Medicine Hospital of Hainan Province Recruiting
Haikou, Hainan, China
Contact: Ping Tan         
Haikou City People's Hospital Recruiting
Haikou, Hainan, China
Contact: Yan Sun         
The People's Hospital of Sanya Recruiting
Sanya, Hainan, China
Contact: Meng Zhang         
China, Hebei
Cangzhou Central Hospital Recruiting
Cangzhou, Hebei, China
Contact: Xiaoyin Ma         
Hebei Province Cangzhou Hospital of Integrated Traditional and Western Medicine Recruiting
Cangzhou, Hebei, China
Contact: Jinrong Ma         
Contact: Weiyi Guo         
Renshou County People's Hospital Recruiting
Chengde, Hebei, China
Contact: Jixian Xu         
The First Hospital of Shijiazhuang Recruiting
Shijiazhuang, Hebei, China
Contact: Lanfen Xue         
Xinle Hospital Recruiting
Shijiazhuang, Hebei, China
Contact: Zhongbing Li         
Contact: Jing Qin         
China, Heilongjiang
Qunli Branch of The First Affiliated Hospital of Harbin Medical University Recruiting
Harbin, Heilongjiang, China
Contact: Lirong Hao         
Jiamsui Central Hospital Recruiting
Jiamusi, Heilongjiang, China
Contact: Changjiang Wang         
Central Hospital of Yichun Forestry Administration Recruiting
Yichun, Heilongjiang, China
Contact: Yanxia Sun         
China, Henan
Kaifeng People's Hospital Recruiting
Kaifeng, Henan, China
Contact: Kai Chen         
Luoyang Central Hospital Recruiting
Luoyang, Henan, China
Contact: Jingwei Zhao         
The First Affiliated Hospital of Henan University of Science and Technology Recruiting
Luoyang, Henan, China
Contact: Junxia Wang         
Contact: Li Zhang         
The First People's Hospital of Pingdingshan Recruiting
Pingdingshan, Henan, China
Contact: Xianchao Zhang         
Puyang Oilfield General Hospital Recruiting
Puyang, Henan, China
Contact: Xianjun Xue         
People's Hospital of Zhengzhou Recruiting
Zhengzhou Shi, Henan, China
Contact: Li Xing         
The 7th People's Hospital of Zhengzhou Recruiting
Zhengzhou, Henan, China
Contact: Jinghua Zhang         
Zhengzhou Third Hospital Recruiting
Zhengzhou, Henan, China
Contact: Yan Cheng         
China, Sichuan
Chengdu Second People's Hospital Recruiting
Chengdu, Sichuan, China
Contact: Xiaoyun Cheng         
The First Affiliated Hospital of Chengdu Medical College Recruiting
Chengdu, Sichuan, China
Contact: Shaoqing Wang         
The Third People's Hospital of Chengdu Recruiting
Chengdu, Sichuan, China
Contact: Manli Liu         
China, Tianjin
The Second hospital of Tianjin medical university Recruiting
Tianjin, Tianjin, China
Contact: Aili Jiang         
China, Yunnan Sheng
People's hospital of Pu 'er city Recruiting
Puer Shi, Yunnan Sheng, China
Contact: Yanyan Li         
China, Yunnan
The First Affiliated Hospital of Dali University Recruiting
Dali, Yunnan, China
Contact: Liru Liu         
The Second Affiliated Hospital of Kunming Medical University Recruiting
Kunming, Yunnan, China, 650221
Contact: Zhijian Feng         
People's Hospital of Pu'er City Recruiting
Pu'er, Yunnan, China
Contact: Zhengrong Zhang         
Qujing Second People's Hospital Recruiting
Qujing, Yunnan, China
Contact: Yan Bai         
The First People's Hospital of Zhaotong Recruiting
Zhaotong, Yunnan, China, 657099
Contact: Chengai Deng         
India
Area Hospital, Kothapeta Road,Chirala, Andhra Pradesh Recruiting
Chirala, Andhra Pradesh, India
Contact: Kamal Shah         
Medical Superintendent Government Hospital Recruiting
Gudur, Andhra Pradesh, India
Contact: Kamal D Shah         
Government General Hospital Recruiting
Guntur, Andhra Pradesh, India
Contact: Kamal D Shah         
Medical Superintendent District Hospital Recruiting
Hindupur PPP, Andhra Pradesh, India
Contact: Kamal D Shah         
Government Area Hospital, Kanigiri, Andhra Pradesh Recruiting
Kanigiri, Andhra Pradesh, India
Contact: Kamal Shah         
Government General Hospital Recruiting
Kurnool, Andhra Pradesh, India
Contact: Kamal D Shah         
Government Hospital Recruiting
Kākināda, Andhra Pradesh, India
Contact: Kamal D Shah         
Government Hospital, Machilipatnam PPP, Andhra Pradesh Recruiting
Machilipatnam, Andhra Pradesh, India
Contact: Kamal Shah         
Government Area Hospital Recruiting
Markapur, Andhra Pradesh, India
Contact: Kamal D Shah         
Government Hospital Recruiting
Nandyal, Andhra Pradesh, India
Contact: Kamal D Shah         
Area Hospital Recruiting
Narsipatnam, Andhra Pradesh, India
Contact: Kamal D Shah         
Government Area Hospital Recruiting
Palakonda, Srikakulam District, Andhra Pradesh, India
Contact: Kamal D Shah         
CHC Government Hospital Recruiting
Palasa, Andhra Pradesh, India
Contact: Kamal D Shah         
Government Area Hospital Recruiting
Parvathipuram, Andhra Pradesh, India
Contact: Kamal D Shah         
Government Hospital Recruiting
Proddatur, Andhra Pradesh, India
Contact: Kamal D Shah         
Government Hospital Recruiting
Rajahmundry, Andhra Pradesh, India
Contact: Kamal D Shah         
CHC Hospital, Sompeta, Andhra Pradesh Recruiting
Sompeta, Andhra Pradesh, India
Contact: Kamal Shah         
Greater Kailash Hospital Recruiting
Tadepalligudem, Andhra Pradesh, India
Contact: Kamal D Shah         
Manasa Kidney Foundation Recruiting
Tirupati, Andhra Pradesh, India
Contact: Kamal D Shah         
Contact: Abhinav Bassi         
Government General Hospital, Vijayavada PPP, Andhra Pradesh Recruiting
Vijayavada, Andhra Pradesh, India
Contact: Kamal Shah         
King George Government Hospital Recruiting
Visakhapatnam, Andhra Pradesh, India
Contact: Kamal D Shah         
Rajiv Gandhi Institute of Medical Sciences, Srikakulam PPP, Andhra Recruiting
Srikakulam, Andhra, India
Contact: Kamal Shah         
Ford Hospital, Khemnichak, Patna Recruiting
Patna, Bihar, India
Contact: Kamal D Shah         
Janak Dulari Hospital, Hanuman Nagar Recruiting
Patna, Bihar, India
Contact: Kamal D Shah         
Aysha Hospital Recruiting
Kilpauk, Chennai, India
Contact: Kamal D Shah         
Contact: Abhinav Bassi         
Retteri Sri Kumaran Health Centre Recruiting
Kolathur, Chennai, India
Contact: Kamal D Shah         
Leelawati Hospital Recruiting
Ambāla, Haryana, India
Contact: Kamal D Shah         
Greater Kailash Hospital Recruiting
Old Palasia, Indore, India
Contact: Kamal D Shah         
ESI Hospital Recruiting
Adityapur, Jharkand, India
Contact: Kamal D Shah         
K.M Memorial Hospital and Research Centre Recruiting
Bokaro, Jharkhand, India
Contact: Kamal D Shah         
Asarfi Hospital Recruiting
Dhanbad, Jharkhand, India
Contact: Kamal D Shah         
Bhagwan Mahavir Medical Superspeciality Hospital Recruiting
Ranchi, Jharkhand, India
Contact: Kaml D Shah         
Guru Nanak Hospital and Research Centre Recruiting
Ranchi, Jharkhand, India
Contact: Kamal D Shah         
Koshys Hospital, Ramamurthy Nagar Recruiting
Bengaluru, Karnataka, India
Contact: Kamal D Shah         
Nephroplus Basaveshwaranagar Recruiting
Bengaluru, Karnataka, India
Contact: Kamal D Shah         
Contact: Abhinav Bassi         
Fortis Suchirayu Hospital Recruiting
Hubli, Karnataka, India
Contact: Kamal D Shah         
Main Hospital, SCCL Recruiting
Kothagudem, Khammam, India
Contact: Kamal D Shah         
Vishesh Hospital Pvt. Ltd, Geeta Bhawan Chouraha Recruiting
Indore, Madhya Pradesh, India
Contact: Kamal D Shah         
Hitwardhak Mandal Hospital Recruiting
Mumbai, Maharashtra, India
Contact: Kamal D Shah         
Contact: Abhinav Bassi         
Lokmanya Hospital Recruiting
Pune, Maharashtra, India
Contact: Kamal D Shah         
Contact: Abhinav Bassi         
Chirayu Hospital Recruiting
Thāne, Maharashtra, India
Contact: Kamal D Shah         
Contact: Abhinav Bassi         
Nephroplus Borivali Standalone Recruiting
Borivali West, Mumbai, India, 400092
Contact: Kamal D Shah         
Contact: Abhinav Bassi         
Bharat Baug Recruiting
Borivali West, Mumbai, India
Contact: Kamal D Shah         
Contact: Abhinav Bassi         
Jyothi Hospital Recruiting
Balasore, Odisha, India
Contact: Kamal D Shah         
Kar Clinic & Hospital Pvt. Ltd. Recruiting
Bhubaneswar, Odisha, India
Contact: Kamal D Shah         
Neelachal Hospital, Kharvel Nagar Recruiting
Bhubaneswar, Odisha, India
Contact: Kamal D Shah         
Satguru Partap Singh Apollo Hospitals Recruiting
Ludhiāna, Punjab, India
Contact: Kamal D Shah         
Contact: Abhinav Bassi         
KG Hospital Recruiting
Coimbatore, Tamil Nadu, India
Contact: Kamal D Shah         
Sudha Hospital, Vadalur Recruiting
Neyveli, Tamil Nadu, India
Contact: Kamal D Shah         
Deepam Hospitals, Pallavaram Recruiting
Chennai, Tamilnadu, India
Contact: Kamal D Shah         
Contact: Abhinav Bassi         
Neyveli Lignite Corporation Hospital Recruiting
Neyveli, Tamilnadu, India
Contact: Kamal D Shah         
Contact: Abhinav Bassi         
Citizens Specialty Hospital Recruiting
Hyderabad, Telangana, India
Contact: Kamal D Shah         
ESI Multi-Specialty Hospital Recruiting
Hyderabad, Telangana, India
Contact: Kamal D Shah         
Contact: Abhinav Bassi         
Vintage Plaza Nephroplus, Road no. 10, Banjara Hills Recruiting
Hyderabad, Telangana, India
Contact: Kamal D Shah         
Government Hospital Recruiting
Khammam, Telangana, India
Contact: Kamal D Shah         
Suraksha Multispecialty Hospital Recruiting
Nalgonda, Telangana, India
Contact: Kamal D Shah         
Contact: Abhinav Bassi         
Nephroplus Standalone Dialysis Center, Easy Marredpally Recruiting
Secunderabad, Telangana, India
Contact: Kamal D Shah         
Contact: Abhinav Bassi         
Madhuraj Hospital Recruiting
Kanpur, Uttar Pradesh, India
Contact: Kamal D Shah         
Ajanta Hospital Recruiting
Lucknow, Uttar Pradesh, India
Contact: Kamal D Shah         
Contact: Abhinav Bassi         
Surbhi Hospital Pvt. Ltd, Sector 35 Recruiting
Noida, Uttar Pradish, India
Contact: Kamal D Shah         
Health Point Hospital, Prannth Pandit Street Recruiting
Kolkata, West Bengal, India
Contact: Kamal D Shah         
Minimal Access Surgery Clinic Pvt Ltd Recruiting
Tamluk, West Bengal, India
Contact: Kamal D Shah         
Baroma Sirona Hospital Recruiting
Uttar Mechgram, West Bengal, India
Contact: Kamal D Shah         
Sponsors and Collaborators
The George Institute
Australasian Kidney Trials Network
Investigators
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Principal Investigator: Meg Jardine, MBBS The George Institute

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Responsible Party: The George Institute
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 11, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by The George Institute:
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