Randomised Evaluation of Sodium Dialysate Levels on Vascular Events (RESOLVE)
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| ClinicalTrials.gov Identifier: NCT02823821 |
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Recruitment Status :
Recruiting
First Posted : July 6, 2016
Last Update Posted : October 10, 2022
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Sponsor:
University of Sydney
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 Hospital Wuerzburg, Medizinische Klinik EINS
Malaysian Society of Nephrology
Malaysian Renal Registry
Information provided by (Responsible Party):
University of Sydney
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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 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 (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 |
|---|---|
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Active Comparator: 137mmol/l
Participating dialysis sites will be randomised to a default dialysate sodium concentration of 137mmol/l
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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. |
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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
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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
| Contact: Nuria Zamora Solano | nuria.zamora@sydney.edu.au | ||
| Contact: Erika Dempsey | erika.dempsey@sydney.edu.au |
Locations
Show 117 study locations
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 Hospital Wuerzburg, Medizinische Klinik EINS
Malaysian Society of Nephrology
Malaysian Renal Registry
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: | 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 | |
| Study Chair: | Christoph Wanner | University Hospital Wuerzburg | |
| Principal Investigator: | Jule Pinter | University Hospital Wuerzburg |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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: | October 10, 2022 |
| Last Verified: | October 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
Keywords provided by University of Sydney:
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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 |