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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02823821
Registration number
NCT02823821
Ethics application status
Date submitted
16/06/2016
Date registered
6/07/2016
Titles & IDs
Public title
Randomised Evaluation of Sodium Dialysate Levels on Vascular Events
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Scientific title
Randomised Evaluation of Sodium Dialysate Levels on Vascular Events
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Secondary ID [1]
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0
GI-AU-RM-2016-01
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Universal Trial Number (UTN)
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Trial acronym
RESOLVE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
End-Stage Kidney Disease
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Condition category
Condition code
Renal and Urogenital
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0
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Kidney disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Default dialysate sodium concentration of 137mmol/l
Other interventions - Default dialysate sodium concentration of 140mmol/l
Active comparator: 137mmol/l - Participating dialysis sites will be randomised to a default dialysate sodium concentration of 137mmol/l
Active comparator: 140mmol/l - Participating dialysis sites will be randomised to a default dialysate sodium concentration of 140mmol/l
Other interventions: 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.
Other interventions: 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.
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Time to first occurrence of an event in the primary composite outcome
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Assessment method [1]
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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.
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Timepoint [1]
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Through to study completion (estimated to occur after an average of 5 years follow up)
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Secondary outcome [1]
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Time to first occurrence of an event in the secondary composite outcome
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Assessment method [1]
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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.
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Timepoint [1]
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Through to study completion (estimated to occur after an average of 5 years follow up)
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Secondary outcome [2]
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Time to first occurrence of each of the individual components of the composite outcomes.
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Assessment method [2]
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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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Timepoint [2]
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Through to study completion (estimated to occur after an average of 5 years follow up)
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Eligibility
Key inclusion 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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Study design
Purpose of the study
Other
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/06/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2024
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Actual
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Sample size
Target
50000
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Royal Adelaide Hospital - Adelaide
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Auburn Hospital - Auburn
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Flinders Medical Centre - Bedford Park
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Moorabbin Hospital - Bentleigh East
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Sunshine Coast University Private Hospital - Birtinya
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Princess Alexandra Hospital - Brisbane
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Redlands Hospital - Brisbane
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Bundaberg Hospital - Bundaberg
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Caloundra Hospital - Caloundra
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Royal Prince Alfred Hospital - Camperdown
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The Canberra Hospital - Canberra
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Peninsula Health - Frankston
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Gympie Hospital - Gympie
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Ipswich Hospital - Ipswich
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Mackay Base Hospital - Mackay
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Logan Hospital - Meadowbrook
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Monash Health Community Dandenong - Melbourne
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Casey Hospital - Melbourne
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Cranbourne Integrated Care Centre - Melbourne
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Nambour General Hospital - Nambour
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Hampstead Dialysis Centre - Northfield
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Concord Repatriation and General Hospital - Sydney
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Blacktown Regional Dialysis Centre - Sydney
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Mt Druitt Community Dialysis Centre - Sydney
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Nepean Hospital - Sydney
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Westmead Hospital - Sydney
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The Queen Elizabeth Hospital - Woodville South
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- Adelaide
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2144 - Auburn
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- Bedford Park
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3165 - Bentleigh East
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- Birtinya
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4102 - Brisbane
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4163 - Brisbane
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4551 - Caloundra
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3199 - Frankston
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4570 - Gympie
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4305 - Ipswich
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4131 - Meadowbrook
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3175 - Melbourne
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3806 - Melbourne
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3977 - Melbourne
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4560 - Nambour
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4575 - Sunshine Coast
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2076 - Sydney
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2139 - Sydney
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2148 - Sydney
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2770 - Sydney
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- Woodville South
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Ontario
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Hechingen
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Homburg
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Mainz
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Munich
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Hayes
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York
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Sydney
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Address
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Other collaborator category [1]
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Other
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Name [1]
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Australasian Kidney Trials Network
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Other
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Australia & New Zealand Dialysis & Transplant Registry
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Other
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The George Institute for Global Health, India
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Other
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The George Institute for Global Health, China
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Other
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Peking University People's Hospital
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Other
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Institute for Clinical Evaluative Sciences
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St. Michaels Hospital
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Other
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University Hospital Wuerzburg, Medizinische Klinik EINS
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Malaysian Society of Nephrology
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Malaysian Renal Registry
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Other collaborator category [11]
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Other
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Comprehensive Clinical Trials Unit, University College London
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Ethics approval
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT02823821
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Trial related presentations / publications
See EJ, Polkinghorne KR. Volume management in haemodialysis patients. Curr Opin Nephrol Hypertens. 2020 Nov;29(6):663-670. doi: 10.1097/MNH.0000000000000642.
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Public notes
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Contacts
Principal investigator
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Meg Jardine
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The University of Sydney, NHMRC Clinical Trials Centre
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Contact person for public queries
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Grace Balicki
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02823821