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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614000070639

Acronym

Mac-SOLID Extension Study

Enrollment

118

Registered

2014-01-21

Start date

2012-03-26

Completion date

2014-07-01

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

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.

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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

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