Abstract
BackgroundThe Sodium Lowering in Dialysate (SoLID) trial is an ongoing a multi-center, prospective, randomised, single-blind (assessor), controlled, parallel assignment clinical trial, enrolling 96 home and self-care hemodialysis (HD) patients from 7 centers in New Zealand. The trial will evaluate the hypothesis that lower dialysate [Na+] during HD results in lower left ventricular (LV) mass. Since it’s inception, observational evidence has suggested increased mortality risk with lower dialysate [Na+], possibly due to exacerbation of intra-dialytic hypotension and subsequent myocardial micro-injury. The Myocardial Micro-injury and Cardiac Remodeling Extension Study in the Sodium Lowering In Dialysate Trial (Mac-SoLID study) aims to determine whether lower dialysate [Na+] results in (i) increased levels of high-sensitivity Troponin T (hsTnT), a well-established marker of intra-dialytic myocardial micro-injury in HD populations, and (ii) increased fixed LV segmental wall motion abnormalities, a marker of recurrent myocardial stunning and micro-injury, and (iii) detrimental changes in LV geometry due to maladaptive homeostatic mechanisms.Methods/designThe SoLID trial and the Mac-SoLID study are funded by the Health Research Council of New Zealand. Key exclusion criteria: patients who dialyse > 3.5 times per week, pre-dialysis serum sodium <135 mM, and maintenance haemodiafiltration. In addition, some medical conditions, treatments or participation in other dialysis trials that contraindicate the study intervention or confound its effects, will be exclusion criteria. The intervention and control groups will receive dialysate sodium 135 mM and 140 mM respectively, for 12 months. The primary outcome measure for the Mac-SOLID study is repeated measures of [hsTnT] at 0, 3, 6, 9, and 12 months. The secondary outcomes will be assessed using cardiac magnetic resonance imaging (MRI), and comprise LV segmental wall motion abnormality scores, LV mass to volume ratio and patterns of LV remodeling at 0 and 12 months.DiscussionThe Mac-SoLID study enhances and complements the SoLID trial. It tests whether potential gains in cardiovascular health (reduced LV mass) which low dialysate [Na+] is expected to deliver, are counteracted by deterioration in cardiovascular health through alternative mechanisms, namely repeated LV stunning and micro-injury.Trial registrationAustralian and New Zealand Clinical Trials Registry number: ACTRN12611000975998.
Highlights
The Sodium Lowering in Dialysate (SoLID) trial is an ongoing a multi-center, prospective, randomised, single-blind, controlled, parallel assignment clinical trial, enrolling 96 home and self-care hemodialysis (HD) patients from 7 centers in New Zealand
The Mac-SoLID study enhances and complements the SoLID trial. It tests whether potential gains in cardiovascular health which low dialysate [Na+] is expected to deliver, are counteracted by deterioration in cardiovascular health through alternative mechanisms, namely repeated left ventricular (LV) stunning and micro-injury
The Sodium Lowering in Dialysate (SoLID) trial [1,2] is an ongoing clinical trial to evaluate the hypothesis that reducing sodium exposure in hemodialysis (HD) patients will result in lower cardiovascular (CV) risk
Summary
The SoLID trial is the first randomized controlled trial to investigate the effect of lower dialysate [Na+] upon LV structure and function, and is close to completion. The SoLID trial will provide data on important patient-centered outcomes, such as the effect of lower dialysate [Na+] on thirst, xerostomia, HRQoL and intra-dialytic hypotension. The information forthcoming from the Mac-SoLID trial may help us to better pinpoint those patients who fit the “frail” phenotype and are inherently unsuitable for dialysis treatment with lower dialysate [Na+]. Authors’ contributions MRM conceived and developed the trial, and participated in the statistical plan and helped to draft the manuscript. ACV participated in the trial design, developed the statistical plan, and helped to draft the manuscript. RSG, IAH, and DORM participated in design and development of the trial, and helped to draft the manuscript. JRdZ and PJM participated in the trial design and coordination, and helped to draft the manuscript.
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