Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
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
Other
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
Recruitment postcode(s) [2] 0 0
2144 - Auburn
Recruitment postcode(s) [3] 0 0
- Bedford Park
Recruitment postcode(s) [4] 0 0
3165 - Bentleigh East
Recruitment postcode(s) [5] 0 0
- Birtinya
Recruitment postcode(s) [6] 0 0
4102 - Brisbane
Recruitment postcode(s) [7] 0 0
4163 - Brisbane
Recruitment postcode(s) [8] 0 0
- Bundaberg
Recruitment postcode(s) [9] 0 0
4551 - Caloundra
Recruitment postcode(s) [10] 0 0
- Camperdown
Recruitment postcode(s) [11] 0 0
- Canberra
Recruitment postcode(s) [12] 0 0
3199 - Frankston
Recruitment postcode(s) [13] 0 0
4570 - Gympie
Recruitment postcode(s) [14] 0 0
4305 - Ipswich
Recruitment postcode(s) [15] 0 0
- 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
Recruitment postcode(s) [21] 0 0
- Northfield
Recruitment postcode(s) [22] 0 0
- Pialba
Recruitment postcode(s) [23] 0 0
- St Leonards
Recruitment postcode(s) [24] 0 0
4575 - Sunshine Coast
Recruitment postcode(s) [25] 0 0
2076 - Sydney
Recruitment postcode(s) [26] 0 0
2139 - Sydney
Recruitment postcode(s) [27] 0 0
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
Country [1] 0 0
Canada
State/province [1] 0 0
Ontario
Country [2] 0 0
Canada
State/province [2] 0 0
Hamilton
Country [3] 0 0
Canada
State/province [3] 0 0
Kingston
Country [4] 0 0
Canada
State/province [4] 0 0
Toronto
Country [5] 0 0
Germany
State/province [5] 0 0
Albstadt
Country [6] 0 0
Germany
State/province [6] 0 0
Berlin
Country [7] 0 0
Germany
State/province [7] 0 0
Bochum
Country [8] 0 0
Germany
State/province [8] 0 0
Darmstadt
Country [9] 0 0
Germany
State/province [9] 0 0
Elsenfeld
Country [10] 0 0
Germany
State/province [10] 0 0
Hechingen
Country [11] 0 0
Germany
State/province [11] 0 0
Homburg
Country [12] 0 0
Germany
State/province [12] 0 0
Langen
Country [13] 0 0
Germany
State/province [13] 0 0
Lichtenfels
Country [14] 0 0
Germany
State/province [14] 0 0
Mainz
Country [15] 0 0
Germany
State/province [15] 0 0
Munich
Country [16] 0 0
Germany
State/province [16] 0 0
Schweinfurt
Country [17] 0 0
Germany
State/province [17] 0 0
Siegburg
Country [18] 0 0
Germany
State/province [18] 0 0
Unna
Country [19] 0 0
Germany
State/province [19] 0 0
Villingen-Schwenningen
Country [20] 0 0
Germany
State/province [20] 0 0
Öhringen
Country [21] 0 0
India
State/province [21] 0 0
Andhra Pradesh
Country [22] 0 0
India
State/province [22] 0 0
Andhra
Country [23] 0 0
India
State/province [23] 0 0
Bihar
Country [24] 0 0
India
State/province [24] 0 0
Chennai
Country [25] 0 0
India
State/province [25] 0 0
Haryana
Country [26] 0 0
India
State/province [26] 0 0
Indore
Country [27] 0 0
India
State/province [27] 0 0
Jharkand
Country [28] 0 0
India
State/province [28] 0 0
Jharkhand
Country [29] 0 0
India
State/province [29] 0 0
Karnataka
Country [30] 0 0
India
State/province [30] 0 0
Khammam
Country [31] 0 0
India
State/province [31] 0 0
Madhya Pradesh
Country [32] 0 0
India
State/province [32] 0 0
Maharashtra
Country [33] 0 0
India
State/province [33] 0 0
Mumbai
Country [34] 0 0
India
State/province [34] 0 0
Odisha
Country [35] 0 0
India
State/province [35] 0 0
Punjab
Country [36] 0 0
India
State/province [36] 0 0
Tamil Nadu
Country [37] 0 0
India
State/province [37] 0 0
Tamilnadu
Country [38] 0 0
India
State/province [38] 0 0
Telangana
Country [39] 0 0
India
State/province [39] 0 0
Uttar Pradesh
Country [40] 0 0
India
State/province [40] 0 0
Uttar Pradish
Country [41] 0 0
India
State/province [41] 0 0
West Bengal
Country [42] 0 0
Malaysia
State/province [42] 0 0
Ampang
Country [43] 0 0
Malaysia
State/province [43] 0 0
Batu Pahat
Country [44] 0 0
Malaysia
State/province [44] 0 0
Beaufort
Country [45] 0 0
Malaysia
State/province [45] 0 0
George Town
Country [46] 0 0
Malaysia
State/province [46] 0 0
Ipoh
Country [47] 0 0
Malaysia
State/province [47] 0 0
Johor Bahru
Country [48] 0 0
Malaysia
State/province [48] 0 0
Kajang
Country [49] 0 0
Malaysia
State/province [49] 0 0
Kangar
Country [50] 0 0
Malaysia
State/province [50] 0 0
Klang
Country [51] 0 0
Malaysia
State/province [51] 0 0
Kota Bharu
Country [52] 0 0
Malaysia
State/province [52] 0 0
Kota Kinabalu
Country [53] 0 0
Malaysia
State/province [53] 0 0
Kuala Kangsar
Country [54] 0 0
Malaysia
State/province [54] 0 0
Kuala Lipis
Country [55] 0 0
Malaysia
State/province [55] 0 0
Kuala Lumpur
Country [56] 0 0
Malaysia
State/province [56] 0 0
Kuantan
Country [57] 0 0
Malaysia
State/province [57] 0 0
Kudat
Country [58] 0 0
Malaysia
State/province [58] 0 0
Kulim
Country [59] 0 0
Malaysia
State/province [59] 0 0
Labuan
Country [60] 0 0
Malaysia
State/province [60] 0 0
Langgar
Country [61] 0 0
Malaysia
State/province [61] 0 0
Lenggong
Country [62] 0 0
Malaysia
State/province [62] 0 0
Malaka
Country [63] 0 0
Malaysia
State/province [63] 0 0
Muar
Country [64] 0 0
Malaysia
State/province [64] 0 0
Permatang Pauh
Country [65] 0 0
Malaysia
State/province [65] 0 0
Petaling Jaya
Country [66] 0 0
Malaysia
State/province [66] 0 0
Shah Alam
Country [67] 0 0
Malaysia
State/province [67] 0 0
Sungai Petani
Country [68] 0 0
Malaysia
State/province [68] 0 0
Sungai Siput
Country [69] 0 0
Malaysia
State/province [69] 0 0
Tambunan
Country [70] 0 0
Malaysia
State/province [70] 0 0
Temerluh
Country [71] 0 0
United Kingdom
State/province [71] 0 0
Altrincham
Country [72] 0 0
United Kingdom
State/province [72] 0 0
Ashton-under-Lyne
Country [73] 0 0
United Kingdom
State/province [73] 0 0
Barnet
Country [74] 0 0
United Kingdom
State/province [74] 0 0
Barnsley
Country [75] 0 0
United Kingdom
State/province [75] 0 0
Bath
Country [76] 0 0
United Kingdom
State/province [76] 0 0
Bedford
Country [77] 0 0
United Kingdom
State/province [77] 0 0
Bexhill-on-Sea
Country [78] 0 0
United Kingdom
State/province [78] 0 0
Blackley
Country [79] 0 0
United Kingdom
State/province [79] 0 0
Bolton
Country [80] 0 0
United Kingdom
State/province [80] 0 0
Bradford
Country [81] 0 0
United Kingdom
State/province [81] 0 0
Bridgwater
Country [82] 0 0
United Kingdom
State/province [82] 0 0
Brighton
Country [83] 0 0
United Kingdom
State/province [83] 0 0
Bristol
Country [84] 0 0
United Kingdom
State/province [84] 0 0
Bromley
Country [85] 0 0
United Kingdom
State/province [85] 0 0
Broomfield
Country [86] 0 0
United Kingdom
State/province [86] 0 0
Cannock
Country [87] 0 0
United Kingdom
State/province [87] 0 0
Chesterfield
Country [88] 0 0
United Kingdom
State/province [88] 0 0
Clacton-on-Sea
Country [89] 0 0
United Kingdom
State/province [89] 0 0
Colchester
Country [90] 0 0
United Kingdom
State/province [90] 0 0
Coventry
Country [91] 0 0
United Kingdom
State/province [91] 0 0
Crawley
Country [92] 0 0
United Kingdom
State/province [92] 0 0
Crewe
Country [93] 0 0
United Kingdom
State/province [93] 0 0
Cromer
Country [94] 0 0
United Kingdom
State/province [94] 0 0
Darlington
Country [95] 0 0
United Kingdom
State/province [95] 0 0
Dartford
Country [96] 0 0
United Kingdom
State/province [96] 0 0
Dover
Country [97] 0 0
United Kingdom
State/province [97] 0 0
Edgware
Country [98] 0 0
United Kingdom
State/province [98] 0 0
Epsom
Country [99] 0 0
United Kingdom
State/province [99] 0 0
Exeter
Country [100] 0 0
United Kingdom
State/province [100] 0 0
Farnborough
Country [101] 0 0
United Kingdom
State/province [101] 0 0
Gloucester
Country [102] 0 0
United Kingdom
State/province [102] 0 0
Great Yarmouth
Country [103] 0 0
United Kingdom
State/province [103] 0 0
Grimsby
Country [104] 0 0
United Kingdom
State/province [104] 0 0
Harlow
Country [105] 0 0
United Kingdom
State/province [105] 0 0
Hayes
Country [106] 0 0
United Kingdom
State/province [106] 0 0
Honiton
Country [107] 0 0
United Kingdom
State/province [107] 0 0
Houghton Regis
Country [108] 0 0
United Kingdom
State/province [108] 0 0
Hull
Country [109] 0 0
United Kingdom
State/province [109] 0 0
Isleworth
Country [110] 0 0
United Kingdom
State/province [110] 0 0
Kingston
Country [111] 0 0
United Kingdom
State/province [111] 0 0
London
Country [112] 0 0
United Kingdom
State/province [112] 0 0
Ludlow
Country [113] 0 0
United Kingdom
State/province [113] 0 0
Macclesfield
Country [114] 0 0
United Kingdom
State/province [114] 0 0
Manchester
Country [115] 0 0
United Kingdom
State/province [115] 0 0
Margate
Country [116] 0 0
United Kingdom
State/province [116] 0 0
Middlesbrough
Country [117] 0 0
United Kingdom
State/province [117] 0 0
North Yorkshire
Country [118] 0 0
United Kingdom
State/province [118] 0 0
Northallerton
Country [119] 0 0
United Kingdom
State/province [119] 0 0
Nuneaton
Country [120] 0 0
United Kingdom
State/province [120] 0 0
Oldham
Country [121] 0 0
United Kingdom
State/province [121] 0 0
Plaistow
Country [122] 0 0
United Kingdom
State/province [122] 0 0
Polegate
Country [123] 0 0
United Kingdom
State/province [123] 0 0
Rochdale
Country [124] 0 0
United Kingdom
State/province [124] 0 0
Romford
Country [125] 0 0
United Kingdom
State/province [125] 0 0
Rotherham
Country [126] 0 0
United Kingdom
State/province [126] 0 0
Rugby
Country [127] 0 0
United Kingdom
State/province [127] 0 0
Salford
Country [128] 0 0
United Kingdom
State/province [128] 0 0
Scarborough
Country [129] 0 0
United Kingdom
State/province [129] 0 0
Scunthorpe
Country [130] 0 0
United Kingdom
State/province [130] 0 0
Sheffield
Country [131] 0 0
United Kingdom
State/province [131] 0 0
Shrewsbury
Country [132] 0 0
United Kingdom
State/province [132] 0 0
Smethwick
Country [133] 0 0
United Kingdom
State/province [133] 0 0
St Albans
Country [134] 0 0
United Kingdom
State/province [134] 0 0
Stafford
Country [135] 0 0
United Kingdom
State/province [135] 0 0
Stevenage
Country [136] 0 0
United Kingdom
State/province [136] 0 0
Stockport
Country [137] 0 0
United Kingdom
State/province [137] 0 0
Stockton-on-Tees
Country [138] 0 0
United Kingdom
State/province [138] 0 0
Stoke-on-Trent
Country [139] 0 0
United Kingdom
State/province [139] 0 0
Stratford-upon-Avon
Country [140] 0 0
United Kingdom
State/province [140] 0 0
Sutton
Country [141] 0 0
United Kingdom
State/province [141] 0 0
Taunton
Country [142] 0 0
United Kingdom
State/province [142] 0 0
Telford
Country [143] 0 0
United Kingdom
State/province [143] 0 0
Thornton Heath
Country [144] 0 0
United Kingdom
State/province [144] 0 0
Torquay
Country [145] 0 0
United Kingdom
State/province [145] 0 0
Tottenham
Country [146] 0 0
United Kingdom
State/province [146] 0 0
Wigan
Country [147] 0 0
United Kingdom
State/province [147] 0 0
Willesborough
Country [148] 0 0
United Kingdom
State/province [148] 0 0
Wolverhampton
Country [149] 0 0
United Kingdom
State/province [149] 0 0
Woolwich
Country [150] 0 0
United Kingdom
State/province [150] 0 0
Worthing
Country [151] 0 0
United Kingdom
State/province [151] 0 0
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/study/NCT02823821
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.
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
[email protected]
Contact person for scientific queries



Summary Results

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