Randomised Evaluation of Sodium Dialysate Levels on Vascular Events (RESOLVE)
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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 |
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Recruitment Status :
Recruiting
First Posted : July 6, 2016
Last Update Posted : March 11, 2020
|
Sponsor:
The George Institute
Collaborator:
Australasian Kidney Trials Network
Information provided by (Responsible Party):
The George Institute
- Study Details
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- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
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.
| 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 :
- 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 :
- 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.
- 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.
| 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
| Contact: Erika Dempsey | edempsey@georgeinstitute.org.au |
Locations
Hide 133 study locations
| 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
| Principal Investigator: | Meg Jardine, MBBS | The George Institute |
| 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:
|
Kidney Diseases Kidney Failure, Chronic Urologic Diseases Renal Insufficiency, Chronic |
Renal Insufficiency Dialysis Solutions Pharmaceutical Solutions |