Mark R Marshall1,2,3, Alain C Vandal4, Janak R de Zoysa5,6, Ruvin S Gabriel7, Imad A Haloob8, Christopher J Hood9, John H Irvine10, Philip J Matheson11, David O R McGregor10, Kannaiyan S Rabindranath12, John B W Schollum13, David J Semple14, Zhengxiu Xie15, Tian Min Ma1, Rose Sisk16, Joanna L Dunlop9. 1. Department of Renal Medicine, Middlemore Hospital, Counties Manukau District Health Board, Auckland, New Zealand; markrogermarshall@icloud.com. 2. School of Medicine, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand. 3. Medical Affairs, Baxter Healthcare (Asia) Pte Ltd., Singapore. 4. Department of Statistics, Faculty of Science, University of Auckland, Auckland, New Zealand. 5. Department of Renal Medicine, North Shore Hospital, Waitemata District Health Board, Auckland, New Zealand. 6. Waitemata Clinical School, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand. 7. Department of Cardiology, Middlemore Hospital, Counties Manukau District Health Board, Auckland, New Zealand. 8. Department of Renal Medicine, Bathurst Base Hospital, New South Wales, Bathurst, Australia. 9. Department of Renal Medicine, Middlemore Hospital, Counties Manukau District Health Board, Auckland, New Zealand. 10. Department of Nephrology, Christchurch Hospital, Canterbury District Health Board, Christchurch, New Zealand. 11. Department of Nephrology, Wellington Hospital, Capital & Coast District Health Board, Wellington, New Zealand. 12. Department of Nephrology, Waikato Hospital, Waikato District Health Board, Hamilton, New Zealand. 13. Nephrology Service, Dunedin Hospital, Southern District Health Board, Dunedin, New Zealand. 14. Department of Renal Medicine, Auckland City Hospital, Auckland District Health Board, Auckland, New Zealand. 15. Middlemore Clinical Trials, Auckland, New Zealand; and. 16. Division of Informatics, Imaging & Data Sciences, School of Health Sciences, University of Manchester, Manchester, United Kingdom.
Abstract
BACKGROUND: Fluid overload in patients undergoing hemodialysis contributes to cardiovascular morbidity and mortality. There is a global trend to lower dialysate sodium with the goal of reducing fluid overload. METHODS: To investigate whether lower dialysate sodium during hemodialysis reduces left ventricular mass, we conducted a randomized trial in which patients received either low-sodium dialysate (135 mM) or conventional dialysate (140 mM) for 12 months. We included participants who were aged >18 years old, had a predialysis serum sodium ≥135 mM, and were receiving hemodialysis at home or a self-care satellite facility. Exclusion criteria included hemodialysis frequency >3.5 times per week and use of sodium profiling or hemodiafiltration. The main outcome was left ventricular mass index by cardiac magnetic resonance imaging. RESULTS: The 99 participants had a median age of 51 years old; 67 were men, 31 had diabetes mellitus, and 59 had left ventricular hypertrophy. Over 12 months of follow-up, relative to control, a dialysate sodium concentration of 135 mmol/L did not change the left ventricular mass index, despite significant reductions at 6 and 12 months in interdialytic weight gain, in extracellular fluid volume, and in plasma B-type natriuretic peptide concentration (ratio of intervention to control). The intervention increased intradialytic hypotension (odds ratio [OR], 7.5; 95% confidence interval [95% CI], 1.1 to 49.8 at 6 months and OR, 3.6; 95% CI, 0.5 to 28.8 at 12 months). Five participants in the intervention arm could not complete the trial because of hypotension. We found no effect on health-related quality of life measures, perceived thirst or xerostomia, or dietary sodium intake. CONCLUSIONS:Dialysate sodium of 135 mmol/L did not reduce left ventricular mass relative to control, despite improving fluid status. CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER: The Australian New Zealand Clinical Trials Registry, ACTRN12611000975998.
RCT Entities:
BACKGROUND: Fluid overload in patients undergoing hemodialysis contributes to cardiovascular morbidity and mortality. There is a global trend to lower dialysate sodium with the goal of reducing fluid overload. METHODS: To investigate whether lower dialysate sodium during hemodialysis reduces left ventricular mass, we conducted a randomized trial in which patients received either low-sodium dialysate (135 mM) or conventional dialysate (140 mM) for 12 months. We included participants who were aged >18 years old, had a predialysis serum sodium ≥135 mM, and were receiving hemodialysis at home or a self-care satellite facility. Exclusion criteria included hemodialysis frequency >3.5 times per week and use of sodium profiling or hemodiafiltration. The main outcome was left ventricular mass index by cardiac magnetic resonance imaging. RESULTS: The 99 participants had a median age of 51 years old; 67 were men, 31 had diabetes mellitus, and 59 had left ventricular hypertrophy. Over 12 months of follow-up, relative to control, a dialysate sodium concentration of 135 mmol/L did not change the left ventricular mass index, despite significant reductions at 6 and 12 months in interdialytic weight gain, in extracellular fluid volume, and in plasma B-type natriuretic peptide concentration (ratio of intervention to control). The intervention increased intradialytic hypotension (odds ratio [OR], 7.5; 95% confidence interval [95% CI], 1.1 to 49.8 at 6 months and OR, 3.6; 95% CI, 0.5 to 28.8 at 12 months). Five participants in the intervention arm could not complete the trial because of hypotension. We found no effect on health-related quality of life measures, perceived thirst or xerostomia, or dietary sodium intake. CONCLUSIONS: Dialysate sodium of 135 mmol/L did not reduce left ventricular mass relative to control, despite improving fluid status. CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER: The Australian New Zealand Clinical Trials Registry, ACTRN12611000975998.
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