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
The Centre for Clinical Research and effective practice (CCRep), registered with the New Zealand Charities Commission (ref# CC21537)
118 participants
Mar 26, 2012
Interventional
Conditions
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.
Eligibility
Inclusion Criteria1
- 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 Criteria8
- Haemodialysis treatments at a frequency of greater than 3.5 times per week
- Treatment with maintenance haemodiafiltration
- Life expectancy of less than 12 months
- Scheduled for live donor kidney transplantation within 12 months of entry to the study
- 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)
- Considered by the treating nephrologist to have a high chance of non-adherence to study treatments and non-attendance for procedures and follow-up
- 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
- Documented obvious infiltrative cardiomyopathies (amyloid, glycogen storage disease), hereditary cardiomyopathies (hypertrophic cardiomyopathy), or moderate to severe aortic valve disease (aortic stenosis, regurgitation)
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Interventions
Low dialysate [Na+] at 135mM up to (and including) 3.5 times per week at every haemodialysis treatment for 12 months
Locations(1)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12611000975998