The effect of lower salt exposure at haemodialysis on cardiac micro-injury, in home and self-care haemodialysis patients.
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
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
The SOLID Trial (ACTRN12611000975998) is currently underway. Its hypothesis is that reduced sodium exposure through the use of lower dialysate sodium concentration will reduce cardiovascular morbidity in haemodialysis patients, by reducing inter-dialytic hypertension and LV mass. The Mac-Solid Extension trial will evaluate whether any benefit of lower dialysate sodium in reducing inter-dialytic hypertension and LV mass might be offset by increased rates of intra-dialytic hypotension and myocardial micro-injury.
Eligibility
Inclusion Criteria6
- Incident or prevalent patients treated with maintenance home or self-care haemodialysis for end-stage kidney failure
- Aged 18 years or older
- Suitable for both low and standard dialysate [Na+] in the view of the treating physician
- The person is willing to participate and has signed the Participant Information and Consent Form
- Pre-dialysis plasma [Na+] > or = 135mM
- 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)
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
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.
Locations(1)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12614000070639