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Open Access Highly Accessed Study protocol

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

Joanna Leigh Dunlop12, Alain Charles Vandal3, Janak Rashme de Zoysa4, Ruvin Sampath Gabriel5, Imad Adbi Haloob6, Christopher John Hood2, Philip James Matheson7, David Owen Ross McGregor8, Kannaiyan Samuel Rabindranath9, David John Semple6 and Mark Roger Marshall12*

Author Affiliations

1 South Auckland Clinical School, Faculty of Medical and Health Sciences, University of Auckland, Private Bag 93311. Otahuhu, Auckland 1640, New Zealand

2 Department of Renal Medicine, Middlemore Hospital, Counties Manukau District Health Board, Private Bag 93311, Otahuhu, Auckland 1640, New Zealand

3 Faculty of Health and Environmental Sciences, Auckland University of Technology, North Shore Campus, Private Bag 92006, Auckland 1142, New Zealand

4 Renal Service, North Shore Hospital, Waitemata District Health Board, Private Bag 93503, Takapuna, Auckland 0740, New Zealand

5 Department of Cardiology, Middlemore Hospital, Counties Manukau District Health Board, Private Bag 93311, Otahuhu, Auckland 1640, New Zealand

6 Department of Renal Medicine, Auckland City Hospital, Auckland District Health Board, Private Bag 92024, Auckland 0740, New Zealand

7 Department of Nephrology, Wellington Hospital, Capital & Coast District Health Board, Private Bag 7902, Wellington South, New Zealand

8 Department of Nephrology, Christchurch Hospital, Canterbury District Health Board, Private Bag 4710, Christchurch, New Zealand

9 Department of Renal Medicine, Waikato Hospital, Waikato District Health Board, Private Bag 3200, Hamilton 3240, New Zealand

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BMC Nephrology 2013, 14:149  doi:10.1186/1471-2369-14-149

Published: 15 July 2013

Abstract

Background

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 hemodialysis patients from 6 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 <135 mM, and maintenance hemodiafiltration. 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 135 mM and 140 mM 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 of 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: ACTRN12611000975998

Keywords:
Home hemodialysis; Dialysis; Left ventricular mass; Sodium; Blood pressure; Fluid overload; Dialysate