![]() The primary outcome was average IDWG (pre-HD weight minus post-HD weight from the previous session). Patients were not aware of dialysate sodium prescription. Gibbs–Donnan effect in HD occurs due to nondiffusable, negatively charged plasma proteins creating an electric field that attracts sodium, thus reducing the diffusion of sodium from plasma across the dialysis membrane. Donnan coefficient is a correction factor applied to get the dialysate sodium value, which will result in eunatremic dialysis. In the second phase of the study, patients were subjected again to 12 consecutive HD sessions, but the dialysate Na+ concentration was set to individualized value (mean of pre-HD Na+ concentration multiplied by Donnan coefficient of 0.95). The pre- and post-HD plasma sodium concentration was determined for each patient in four different midweek dialysis sessions and their mean was calculated. In the first phase, patients were submitted to 12 consecutive HD sessions with a standard dialysate sodium concentration fixed at 140 mEq/L, which is the standard concentration used in our dialysis facility. The study was performed in two different phases, with each subject used as his or her own control. The exclusion criteria were as follows: (1) expected life expectancy less than 6 months, (2) pre-HD sodium less than 130 meq/L or >140 meq/L at recruitment, (3) considered by the treating nephrologist to have concomitant illnesses or conditions that limit or contraindicate study procedures and follow-up, (4) documented infiltrative cardiomyopathies (amyloidosis, glycogen storage disease), hereditary cardiomyopathies (hypertrophic cardiomyopathy), or moderate to severe aortic valve disease (aortic stenosis, regurgitation), and (5) amputees. A sample size of 40 was calculated based on the reference study by De Paula et al., to detect a difference of 0.48 kg weight between the two phases with 80% power and 5% level of significance and assuming a dropout rate of 10%.Ĭonsented patients who were above 18 years of age and were on thrice-weekly maintenance HD for at least 6 weeks were enrolled in the study. The trial was a prospective intervention trial approved by the institutional review board of Christian Medical College, Vellore, and registered with Clinical Trial Registry of the Government of India (CTRI reg no. Our objective was to study whether individualization of dialysate sodium concentration will improve IDWG, BP, fluid overload, and HD-related symptoms. There are hardly any studies from India and Asia in this regard. Several studies have been done around the world regarding the utility of individualizing sodium prescription in HD patients, but the results have been inconsistent. Theoretically, it looks advantageous to use tailor-made sodium dialysate to avoid addition of excess sodium to the body during HD sessions. Long-standing fluid overload can lead to uncontrolled hypertension, left ventricular hypertrophy (LVH), and thus lead to cardiovascular morbidity and mortality. These patients might be actually having a lower sodium set point and if so, with each HD session, more sodium is being added to their body, contributing to increased thirst, interdialytic weight gain (IDWG) and blood pressure (BP). This can promote interdialytic fluid ingestion to restore an individual's sodium and osmolar set point. A higher dialysate sodium concentration more than the patient's plasma sodium level will cause sodium gain during dialysis and increase the total body sodium. It is known that dialysis patients have an individualized sodium and osmolarity value, which are known as sodium and osmolar set points, respectively, which are unique for each patient and is highly conserved. This dialysate sodium level is used in all patients irrespective of their blood sodium values. Currently, all patients undergoing maintenance HD in our center and many centers worldwide are dialysed with dialysate sodium of 140 meq/L. Sodium entry occurs in HD patients from dietary intake, from dialysis fluid during each HD session, or from saline infusions given during HD. Volume overload is a major problem in patients on hemodialysis (HD) and is mainly contributed by sodium overload. Sodium is the major extracellular cation in the body, and hence is the major determinant of extracellular fluid (ECF) content and serum osmolarity.
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