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The effect of lower salt exposure on the cardiac structure and function of patients on home haemodialysis

A randomised, controlled trial of low sodium dialysate versus conventional sodium dialysate to reduce left ventricular mass index in patients receiving home haemodialysis

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12611000975998
Acronym
The SOdium Lowering In Dialysate (SOLID) Trial
Enrollment
118
Registered
2011-09-13
Start date
2012-03-26
Completion date
2014-07-31
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

Low dialysate [Na+] at 135mM up to (and including) 3.5 times per week at every haemodialysis treatment for 12 months

Sponsors

The Centre for Clinical Research and effective practice (CCRep), registered with the New Zealand Charities Commission (ref# CC21537)
Lead SponsorCharities/Societies/Foundations

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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

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)

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 23, 2026