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

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ClinicalTrials.gov Identifier: NCT02823821
Recruitment Status : Recruiting
First Posted : July 6, 2016
Last Update Posted : November 12, 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.



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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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Sponsors and Collaborators
The George Institute
Australasian Kidney Trials Network
Investigators
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Principal Investigator: Meg Jardine, MBBS The George Institute
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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: November 12, 2020
Last Verified: November 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