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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02823821




Registration number
NCT02823821
Ethics application status
Date submitted
16/06/2016
Date registered
6/07/2016
Date last updated
7/06/2024

Titles & IDs
Public title
Randomised Evaluation of Sodium Dialysate Levels on Vascular Events
Scientific title
Randomised Evaluation of Sodium Dialysate Levels on Vascular Events
Secondary ID [1] 0 0
GI-AU-RM-2016-01
Universal Trial Number (UTN)
Trial acronym
RESOLVE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
End-Stage Kidney Disease 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to first occurrence of an event in the primary composite outcome
Timepoint [1] 0 0
Through to study completion (estimated to occur after an average of 5 years follow up)
Secondary outcome [1] 0 0
Time to first occurrence of an event in the secondary composite outcome
Timepoint [1] 0 0
Through to study completion (estimated to occur after an average of 5 years follow up)
Secondary outcome [2] 0 0
Time to first occurrence of each of the individual components of the composite outcomes.
Timepoint [2] 0 0
Through to study completion (estimated to occur after an average of 5 years follow up)

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Health Services Research
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2024
Actual
Sample size
Target
50000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
Auburn Hospital - Auburn
Recruitment hospital [3] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [4] 0 0
Moorabbin Hospital - Bentleigh East
Recruitment hospital [5] 0 0
Sunshine Coast University Private Hospital - Birtinya
Recruitment hospital [6] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [7] 0 0
Redlands Hospital - Brisbane
Recruitment hospital [8] 0 0
Bundaberg Hospital - Bundaberg
Recruitment hospital [9] 0 0
Caloundra Hospital - Caloundra
Recruitment hospital [10] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [11] 0 0
The Canberra Hospital - Canberra
Recruitment hospital [12] 0 0
Peninsula Health - Frankston
Recruitment hospital [13] 0 0
Gympie Hospital - Gympie
Recruitment hospital [14] 0 0
Ipswich Hospital - Ipswich
Recruitment hospital [15] 0 0
Mackay Base Hospital - Mackay
Recruitment hospital [16] 0 0
Logan Hospital - Meadowbrook
Recruitment hospital [17] 0 0
Monash Health Community Dandenong - Melbourne
Recruitment hospital [18] 0 0
Casey Hospital - Melbourne
Recruitment hospital [19] 0 0
Cranbourne Integrated Care Centre - Melbourne
Recruitment hospital [20] 0 0
Nambour General Hospital - Nambour
Recruitment hospital [21] 0 0
Hampstead Dialysis Centre - Northfield
Recruitment hospital [22] 0 0
Hervey Bay Hospital - Pialba
Recruitment hospital [23] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [24] 0 0
Sunshine Coast University Hospital - Sunshine Coast
Recruitment hospital [25] 0 0
Sydney Adventist Hospital - Sydney
Recruitment hospital [26] 0 0
Concord Repatriation and General Hospital - Sydney
Recruitment hospital [27] 0 0
Blacktown Regional Dialysis Centre - Sydney
Recruitment hospital [28] 0 0
Mt Druitt Community Dialysis Centre - Sydney
Recruitment hospital [29] 0 0
Nepean Hospital - Sydney
Recruitment hospital [30] 0 0
Westmead Hospital - Sydney
Recruitment hospital [31] 0 0
The Queen Elizabeth Hospital - Woodville South
Recruitment postcode(s) [1] 0 0
- Adelaide
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2144 - Auburn
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- Bedford Park
Recruitment postcode(s) [4] 0 0
3165 - Bentleigh East
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- Birtinya
Recruitment postcode(s) [6] 0 0
4102 - Brisbane
Recruitment postcode(s) [7] 0 0
4163 - Brisbane
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- Bundaberg
Recruitment postcode(s) [9] 0 0
4551 - Caloundra
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- Camperdown
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- Canberra
Recruitment postcode(s) [12] 0 0
3199 - Frankston
Recruitment postcode(s) [13] 0 0
4570 - Gympie
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4305 - Ipswich
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- Mackay
Recruitment postcode(s) [16] 0 0
4131 - Meadowbrook
Recruitment postcode(s) [17] 0 0
3175 - Melbourne
Recruitment postcode(s) [18] 0 0
3806 - Melbourne
Recruitment postcode(s) [19] 0 0
3977 - Melbourne
Recruitment postcode(s) [20] 0 0
4560 - Nambour
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- Northfield
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- Pialba
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- St Leonards
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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
Recruitment postcode(s) [28] 0 0
2770 - Sydney
Recruitment postcode(s) [29] 0 0
- Sydney
Recruitment postcode(s) [30] 0 0
- Woodville South
Recruitment outside Australia
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Canada
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Ontario
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Canada
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Hamilton
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Canada
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Kingston
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Canada
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Toronto
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Germany
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Albstadt
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Berlin
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Bochum
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Darmstadt
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Elsenfeld
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Hechingen
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Homburg
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Langen
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Lichtenfels
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Mainz
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Munich
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Schweinfurt
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Germany
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Siegburg
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Germany
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Unna
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Germany
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Villingen-Schwenningen
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Germany
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Öhringen
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India
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Andhra Pradesh
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Andhra
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Bihar
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Chennai
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Haryana
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Indore
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Jharkand
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Karnataka
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Khammam
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York

Funding & Sponsors
Primary sponsor type
Other
Name
University of Sydney
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Australasian Kidney Trials Network
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Australia & New Zealand Dialysis & Transplant Registry
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
The George Institute for Global Health, India
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
The George Institute for Global Health, China
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Peking University People's Hospital
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
Institute for Clinical Evaluative Sciences
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Other
Name [7] 0 0
St. Michaels Hospital
Address [7] 0 0
Country [7] 0 0
Other collaborator category [8] 0 0
Other
Name [8] 0 0
University Hospital Wuerzburg, Medizinische Klinik EINS
Address [8] 0 0
Country [8] 0 0
Other collaborator category [9] 0 0
Other
Name [9] 0 0
Malaysian Society of Nephrology
Address [9] 0 0
Country [9] 0 0
Other collaborator category [10] 0 0
Other
Name [10] 0 0
Malaysian Renal Registry
Address [10] 0 0
Country [10] 0 0
Other collaborator category [11] 0 0
Other
Name [11] 0 0
Comprehensive Clinical Trials Unit, University College London
Address [11] 0 0
Country [11] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02823821
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Meg Jardine
Address 0 0
The University of Sydney, NHMRC Clinical Trials Centre
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Grace Balicki
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
grace.balicki@sydney.edu.au
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02823821