Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000070639
Ethics application status
Approved
Date submitted
10/12/2013
Date registered
21/01/2014
Date last updated
21/01/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of lower salt exposure at haemodialysis on cardiac micro-injury, in home and self-care haemodialysis patients.
Scientific title
A randomised controlled trial of low versus normal dialysate sodium, to assess the effect on myocardial micro-injury in patients on home and self-care haemodialysis
Secondary ID [1] 283690 0
Health Research Council of New Zealand 13-442
Universal Trial Number (UTN)
Trial acronym
Mac-SOLID Extension Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular outcomes 290652 0
End-Stage Kidney Disease 290653 0
Condition category
Condition code
Renal and Urogenital 291032 291032 0 0
Kidney disease
Cardiovascular 291033 291033 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Low dialysate [Na+] at 135mM up to (and including) 7 times per fortnight (average 3.5 times per week) at every haemodialysis treatment for 12 months.
Dialysate Na+ will be set in service mode and locked to 135mM on patient's machine, so as machine defaults to 135mM every time it is turned on for the 12 month study period.
Intervention code [1] 288389 0
Treatment: Other
Comparator / control treatment
Standard dialysate [Na+] at 140mM up to (and including) 7 times per fortnight (average 3.5 times per week) at every haemodialysis treatment for 12 months.
Dialysate Na+ will be set in service mode and locked to 140mM on patient's machine, so as machine defaults to 140mM every time it is turned on for the 12 month study period.
Control group
Dose comparison

Outcomes
Primary outcome [1] 291018 0
The primary outcome measure is High-Sensitivity Troponin (hsTnT).
hsTnT assay will be performed on frozen serum samples which are being drawn immeadiately prior to haemodialysis after a long break.
Timepoint [1] 291018 0
0,3,6,9,12 months.
Secondary outcome [1] 305851 0
Segmental Wall Motion Index (SWMI) measured on cardiac MRIs performed prior to haemodialysis treatments and after a long break.
Timepoint [1] 305851 0
0 and 12 months

Eligibility
Key inclusion criteria
1. Incident or prevalent patients treated with maintenance home or self-care haemodialysis for end-stage kidney failure
2. Aged 18 years or older
3. Suitable for both low and standard dialysate [Na+] in the view of the treating physician
4. The person is willing to participate and has signed the Participant Information and Consent Form
5. Pre-dialysis plasma [Na+] > or = 135mM
6. The treating nephrologist agrees to the person’s participation in the SOLID trial
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Haemodialysis treatments at a frequency of greater than 3.5 times per week
2. Treatment with maintenance haemodiafiltration
3. Life expectancy of less than 12 months
4. Scheduled for live donor kidney transplantation within 12 months of entry to the study
5. Considered by the treating nephrologist to have concomitant illnesses or conditions that limit or contraindicate study procedures and followup (e.g. frequent intra-dialytic hypotension requiring fluid resuscitation)
6. Considered by the treating nephrologist to have a high chance of non-adherence to study treatments and non-attendance for procedures and follow-up
7. Current enrolment in clinical studies involving antihypertensive medications, changes in HD operating parameters, or any other intervention that is likely to confound the outcome of this trial
8. Documented obvious infiltrative cardiomyopathies (amyloid, glycogen storage disease), hereditary cardiomyopathies (hypertrophic cardiomyopathy), or moderate to severe aortic valve disease (aortic stenosis, regurgitation)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomization by computer software, stratified by (a) treating centre, and (b) conventional (=18 hours/week) versus extended-hour (>18 hours/week) HD.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis
For the primary(non-inferiority) outcome, analyses will use both intention to treat and per-protocol approaches.
For the secondary(superiority) outcome, the primary analyses will use an intention-to-treat approach.

For sample size considerations, we used published literature employing the 4th generation Roche hsTnT assay (Elecsys). Baseline levels of hsTnT were obtained from a NZ study of HD patients using the same assay. Published literature has robustly established that important and detectable myocardial micro-injury is associated with a 2 to 4 fold increase in the pre-dialysis [hsTnT] of HD patients. To assess non-inferiority of the dialysate sodium arms we computed the two sided 95% confidence interval of the difference between them. Using this method, low dialysate sodium concentration is not inferior to standard dialysate sodium concentration at a 2.5% level if the upper boundary is bleow the pre-specified margin of non-inferiority. Modelling a doubling of [hsTnT] from 118ng/L to 236ng/L, 96 participants in each group and a within-group standard deviation of 291ng/L would have a 80% power to reject the null hypothesis that low dialysate sodium concentration is inferior to standard dialysate sodium concentration. Modelling a quadrupaling of [hsTnt], 22 patients in each group would be needed. Adjustment for baseline values of the [hsTnT] would be expected to increase power by giving narrow confidence intervals.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/02/2012
Actual
26/03/2012
Date of last participant enrolment
Anticipated
1/07/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
118
Accrual to date
Final
Recruitment outside Australia
Country [1] 5663 0
New Zealand
State/province [1] 5663 0

Funding & Sponsors
Funding source category [1] 288376 0
Government body
Name [1] 288376 0
Health Research Council (HRC) of New Zealand
Country [1] 288376 0
New Zealand
Primary sponsor type
Charities/Societies/Foundations
Name
The Centre for Clinical Research and effective practice (CCRep), registered with the New Zealand Charities Commission (ref# CC21537)
Address
Middlemore Hospital, Private Bag 93311, Otahuhu, Auckland 1640
Country
New Zealand
Secondary sponsor category [1] 287079 0
None
Name [1] 287079 0
Address [1] 287079 0
Country [1] 287079 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290256 0
New Zealand Health and Disabililty Multi-region Ethics Committee
Ethics committee address [1] 290256 0
Ethics committee country [1] 290256 0
New Zealand
Date submitted for ethics approval [1] 290256 0
Approval date [1] 290256 0
Ethics approval number [1] 290256 0
MEC/11/09/081 271789 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 44722 0
A/Prof Mark Marshall
Address 44722 0
Department of Renal Medicine Counties Manukau District Health Board Private Bag 93311, Auckland 1640
Country 44722 0
New Zealand
Phone 44722 0
+649276000
Fax 44722 0
Email 44722 0
[email protected]
Contact person for public queries
Name 44723 0
Joanna Dunlop
Address 44723 0
Department of Renal Medicine Counties Manukau District Health Board Private Bag 93311, Auckland 1640
Country 44723 0
New Zealand
Phone 44723 0
+649276000
Fax 44723 0
Email 44723 0
[email protected]
Contact person for scientific queries
Name 44724 0
Mark Marshall
Address 44724 0
Department of Renal Medicine Counties Manukau District Health Board Private Bag 93311, Auckland 1640
Country 44724 0
New Zealand
Phone 44724 0
+649276000
Fax 44724 0
Email 44724 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.