Rationale and design of the Sodium Lowering In Dialysate (SoLID) trial: A randomised controlled trial of low versus standard dialysate sodium concentration during hemodialysis for regression of left ventricular mass

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aut.relation.journalBMC Nephrologyen_NZ
aut.relation.startpage149
aut.relation.volume14en_NZ
aut.researcherVandal, Alain
dc.contributor.authorDunlop, JLen_NZ
dc.contributor.authorVandal, ACen_NZ
dc.contributor.authordeZoysa, JRen_NZ
dc.contributor.authorGabriel, RSen_NZ
dc.contributor.authorHaloob, IAen_NZ
dc.contributor.authorHood, CJen_NZ
dc.contributor.authorMatheson, PJen_NZ
dc.contributor.authorMcGregor, DORen_NZ
dc.contributor.authorRabindranath, KSen_NZ
dc.contributor.authorSemple, DJen_NZ
dc.contributor.authorMarshall, MRen_NZ
dc.date.accessioned2018-09-10T22:37:23Z
dc.date.available2018-09-10T22:37:23Z
dc.date.copyright2013en_NZ
dc.date.issued2013en_NZ
dc.description.abstractBackground The current literature recognises that left ventricular hypertrophy makes a key contribution to the high rate of premature cardiovascular mortality in dialysis patients. Determining how we might intervene to ameliorate left ventricular hypertrophy in dialysis populations has become a research priority. Reducing sodium exposure through lower dialysate sodium may be a promising intervention in this regard. However there is clinical equipoise around this intervention because the benefit has not yet been demonstrated in a robust prospective clinical trial, and several observational studies have suggested sodium lowering interventions may be deleterious in some dialysis patients. Methods/Design The Sodium Lowering in Dialysate (SoLID) study is funded by the Health Research Council of New Zealand. It is a multi-centre, prospective, randomised, single-blind (outcomes assessor), controlled parallel assignment 3-year clinical trial. The SoLID study is designed to study what impact low dialysate sodium has upon cardiovascular risk in dialysis patients. The study intends to enrol 118 home haemodialysis patients from 5 sites in New Zealand over 24 months and follow up each participant over 12 months. Key exclusion criteria are: patients who dialyse more frequently than 3.5 times per week, pre-dialysis serum sodium of <135mM, and maintenance haemodiafiltration. In addition, some medical conditions, treatments or participation in other dialysis trials, which contraindicate the SoLID study intervention or confound its effects, will be exclusion criteria. The intervention and control groups will be dialysed using dialysate sodium 135mM and 140mM respectively, for 12 months. The primary outcome measure is left ventricular mass index, as measured by cardiac magnetic resonance imaging, after 12 months of intervention. Eleven or more secondary outcomes will be studied in an attempt to better understand the physiologic and clinical mechanisms by which lower dialysate sodium alters the primary end point. Discussion The SoLID study is designed to clarify the effect low dialysate sodium upon the cardiovascular outcomes of dialysis patients. The study results will provide much needed information about the efficacy of a cost effective, economically sustainable solution to a condition which is curtailing the lives of so many dialysis patients. Trial Registration Australian and New Zealand Clinical Trials Registry number: ACTRN12611000975998en_NZ
dc.identifier.citationBMC Nephrology, 14(1), 149.
dc.identifier.doi10.1186/1471-2369-14-149
dc.identifier.urihttps://hdl.handle.net/10292/11799
dc.publisherBioMed Central Ltd
dc.relation.urihttps://bmcnephrol.biomedcentral.com/articles/10.1186/1471-2369-14-149
dc.rights© Dunlop et al.; licensee BioMed Central Ltd. 2013 This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
dc.rights.accessrightsOpenAccessen_NZ
dc.subjectHome hemodialysisen_NZ
dc.subjectDialysisen_NZ
dc.subjectLeft ventricular massen_NZ
dc.subjectSodiumen_NZ
dc.subjectBlood pressureen_NZ
dc.subjectFluid overloaden_NZ
dc.subjectDialysateen_NZ
dc.titleRationale and design of the Sodium Lowering In Dialysate (SoLID) trial: A randomised controlled trial of low versus standard dialysate sodium concentration during hemodialysis for regression of left ventricular massen_NZ
dc.typeJournal Article
pubs.elements-id153548
pubs.organisational-data/AUT
pubs.organisational-data/AUT/Health & Environmental Science
pubs.organisational-data/AUT/PBRF
pubs.organisational-data/AUT/PBRF/PBRF Health and Environmental Sciences
pubs.organisational-data/AUT/PBRF/PBRF Health and Environmental Sciences/HY Public Health & Psychosocial Studies 2018 PBRF
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