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Trial registered on ANZCTR


Trial ID
ACTRN12611000975998
Ethics application status
Approved
Date submitted
10/09/2011
Date registered
13/09/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of lower salt exposure on the cardiac structure and function of patients on home haemodialysis
Scientific title
A randomised, controlled trial of low sodium dialysate versus conventional sodium dialysate to reduce left ventricular mass index in patients receiving home haemodialysis
Secondary ID [1] 263020 0
Health Research Council (HRC) of New Zealand 11-583
Secondary ID [2] 263021 0
New Zealand Health and Disability Multi-region Ethics Committee MEC/11/09/081
Universal Trial Number (UTN)
U1111-1124-4705
Trial acronym
The SOdium Lowering In Dialysate (SOLID) Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular outcomes in dialysis patients 270746 0
Condition category
Condition code
Cardiovascular 270924 270924 0 0
Other cardiovascular diseases
Renal and Urogenital 270943 270943 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Low dialysate [Na+] at 135mM up to (and including) 3.5 times per week at every haemodialysis treatment for 12 months
Intervention code [1] 269362 0
Treatment: Devices
Intervention code [2] 269377 0
Treatment: drugs
Intervention code [3] 269378 0
Prevention
Comparator / control treatment
Standard dialysate [Na+] at 140mM up to (and including) 3.5 times per week at every haemodialysis treatment for 12 months
Control group
Dose comparison

Outcomes
Primary outcome [1] 279591 0
Left ventricular mass index (left ventricular mass / body surface area), as measured using cardiac MRI
Timepoint [1] 279591 0
At baseline and 12 months after randomization
Secondary outcome [1] 287992 0
Left ventricular volumes, as measured using cardiac MRI
Timepoint [1] 287992 0
At baseline and 12 months after randomization
Secondary outcome [2] 287993 0
Left ventricular haemodynamics, as assessed by NT-pro-BNP and Urotensin II levels
Timepoint [2] 287993 0
At baseline, 3, 6, 9, and 12 months after randomization
Secondary outcome [3] 287994 0
Extracellular fluid volume, as measured using bioimpedance spectroscopy
Timepoint [3] 287994 0
At baseline, 3, 6, 9, and 12 months after randomization
Secondary outcome [4] 287995 0
Intra-dialytic BP measured as the median BP obtained during a midweek HD treatment
Timepoint [4] 287995 0
At baseline, 3, 6, 9, and 12 months after randomization
Secondary outcome [5] 287996 0
Inter-dialytic BP measured as ambulatory recordings during a "long break"
Timepoint [5] 287996 0
At baseline, 6, and 12 months after randomization
Secondary outcome [6] 287997 0
Inter-dialytic weight gain (pre-dialysis weight minus post-dialysis weight)
Timepoint [6] 287997 0
At baseline, 3, 6, 9, and 12 months after randomization
Secondary outcome [7] 287998 0
Thirst and xerostomia, as measured using the Dialysis Thirst Inventory and Short Xerostomia Inventory
Timepoint [7] 287998 0
At baseline, 3, 6, 9, and 12 months after randomization
Secondary outcome [8] 287999 0
Long-term cardiovascular mortality risk, as assessed by hsCRP levels
Timepoint [8] 287999 0
At baseline, 3, 6, 9, and 12 months after randomization
Secondary outcome [9] 288000 0
Arterial compliance, as assessed by pulse wave velocity
Timepoint [9] 288000 0
At baseline, 3, 6, 9, and 12 months after randomization
Secondary outcome [10] 288001 0
Pre- and post- dialysis plasma Na+ ionic activity, as measured using direct ionometry
Timepoint [10] 288001 0
At baseline, 3, 6, 9, and 12 months after randomization
Secondary outcome [11] 288002 0
Tolerance to dialysis as assessed by the frequency of intra-dialytic hypotension and requirement for fluid boluses
Timepoint [11] 288002 0
At baseline, 3, 6, 9, and 12 months after randomization
Secondary outcome [12] 288003 0
Health-related quality of life, as measured using the KDQOL and the EuroQol EQ-5D questionnaires
Timepoint [12] 288003 0
At baseline and 12 months after randomization
Secondary outcome [13] 307751 0
Myocardial microinjury, as assessed by pre-dialysis levels of high sensitivity Troponin T levels
Timepoint [13] 307751 0
At baseline, 3, 6, 9, and 12 months after randomization
Secondary outcome [14] 307752 0
Segmental left ventricular wall motion analysis using cardiac MRI according to a standard 17-segment score (each segment will be analysed individually and scored on the basis of motion and systolic thickening : normal or hyperdynamic - 1, hypokinetic – 2, akinetic -3, dyskinetic – 4, aneurysmal - 5. A segmental wall motion score index will be derived by dividing the sum of the wall motion scores by the number of segments visualised)
Timepoint [14] 307752 0
At baseline and 12 months
Secondary outcome [15] 307753 0
Pattern of abnormal left ventricular remodeling using cardiac MRI: concentric hypertrophy, eccentric hypertrophy, and concentric remodeling as defined by absence or presence of left ventricular hypertrophy PLUS the absence or presence of an elevated left ventricular mass/left ventricular end-diastolic volume (M-C) ratio, with a partition value for elevated M-C ratio of 2.0
Timepoint [15] 307753 0
At baseline and 12 months

Eligibility
Key inclusion criteria
1. Incident or prevalent patients treated with maintenance home haemodialysis or self care facility 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
Gender
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
Prevention
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?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Efficacy

Recruitment
Recruitment status
Recruiting
Anticipated date of first participant enrolment
1/02/2012
Actual date of first participant enrolment
26/03/2012
Anticipated date last participant enrolled
31/07/2014
Actual date last participant enrolled
Anticipated date of last data collection
Actual date of last data collection
Target sample size
118
Actual sample size
Recruitment outside Australia
Country [1] 3835 0
New Zealand
State/province [1] 3835 0

Funding & Sponsors
Funding source category [1] 269822 0
Government body
Name [1] 269822 0
Health Research Council (HRC) of New Zealand
Address [1] 269822 0
PO Box 5541, Wellesley Street, Auckland 1141
Country [1] 269822 0
New Zealand
Funding source category [2] 269823 0
Charities/Societies/Foundations
Name [2] 269823 0
The Maurice and Phyllis Paykel Trust
Address [2] 269823 0
PO Box 37760, Parnell, Auckland 1151
Country [2] 269823 0
New Zealand
Funding source category [3] 289070 0
Charities/Societies/Foundations
Name [3] 289070 0
Royal Australasian College of Physicians
Address [3] 289070 0
145 Macquarie St, Sydney NSW 2000, Australia
Country [3] 289070 0
Australia
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] 268855 0
None
Name [1] 268855 0
Address [1] 268855 0
Country [1] 268855 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271789 0
New Zealand Health and Disabililty Multi-region Ethics Committee
Ethics committee address [1] 271789 0
PO Box 5013, Lambton Quay, Wellington 6145
Ethics committee country [1] 271789 0
New Zealand
Date submitted for ethics approval [1] 271789 0
02/09/2011
Approval date [1] 271789 0
Ethics approval number [1] 271789 0
MEC/11/09/081

Summary
Brief summary
Home haemodialysis is a common and relatively inexpensive form of dialysis in New Zealand that generally provides good quality of life. However, survival is still poor compared to the general population and 67% of patients die from cardiovascular disease. The SOLID Trial evaluates a cost-free intervention that would potentially improve these patients’ cardiovascular outcomes. The intervention involves reducing salt administration during routine dialysis. Earlier research in South Auckland showed that this simple measure reduces blood pressure. The SOLID Trial tests whether this measure also improves cardiac structure and function, since this would in turn reduce the risk of sudden cardiac death. If the intervention works, it would become the standard practice both locally and globally, and improve survival for all dialysis patients but especially those undergoing home HD. Remarkably, the intervention may be one of the few in medicine to provide health benefits at no added cost.
Trial website
http://www.solid.org.nz
Trial related presentations / publications
Public notes
Attachments [1] 28 28 0 0
http://www.anzctr.org.au/AnzctrAttachments/343461-1471-2369-14-149.pdf

Contacts
Principal investigator
Name 33139 0
A/Prof Mark R Marshall
Address 33139 0
Counties Manukau District Health Board, Private Bag 93311, Auckland 1640, New Zealand
Country 33139 0
New Zealand
Phone 33139 0
+64 21 461766
Fax 33139 0
Email 33139 0
mrmarsh@woosh.co.nz
Contact person for public queries
Name 16386 0
Mrs Brenda Luey
Address 16386 0
Centre for Clinical Research and effective practice
Middlemore Hospital
Private Bag 93311, Auckland 1640
Country 16386 0
New Zealand
Phone 16386 0
+64 (21) 824982
Fax 16386 0
+64 (9) 2503878
Email 16386 0
Jenny.Han@ccrep.org.nz
Contact person for scientific queries
Name 7314 0
A/Prof Mark R Marshall
Address 7314 0
Department of Renal Medicine
Counties Manukau District Health Board
Private Bag 93311, Auckland 1640
Country 7314 0
New Zealand
Phone 7314 0
+64 (21) 461766
Fax 7314 0
Email 7314 0
solid.leadinvestigator@gmail.com