Abstract
BackgroundEvidence indicates favorable effects of dialysate (DNa+) to serum sodium concentration (SNa+) alignment, however, results from larger sample populations are needed. For this reason, we conducted a retrospective propensity score-matched cohort study from a quality improvement project to investigate the effects of alignment on population of maintenance hemodialysis patients.MethodsAt 4 participating hemodialysis (HD) clinics, patients with SNa+ lower than the standard DNa+ of 137 mEq/L who received HD with DNa+ aligned to the average of the last 4 SNa+ measurements were evaluated (clinicaltrials.gov #NCT01825590). In this retrospective data analysis, an intention-to-treat (primary) and an as-treated “intervention” (secondary) cohort were created. “Aligned” patients from both cohorts (N = 163 for the primary and N = 137 for the secondary) were then propensity-score matched in a 1:1 fashion to “unaligned” patients from the Renal Research Institute database. The propensity score was generated based on age, gender, white race, Hispanic ethnicity, absence or presence of diabetes, hemodialysis vintage, interdialytic weight gain (IDWG; as a percentage of postdialysis body weight), catheter as primary dialysis access, predialysis systolic blood pressure, serum sodium concentration, hospitalization count during baseline. T-Test was employed for group comparisons of changes to the primary (volume-related and hemodynamic parameters) and tertiary outcomes. All-cause and fluid overload-related hospitalization admission rates were compared using Wilcoxon Rank Sum test and Cox regression analysis for repeated events.ResultsIn the primary analysis, aligned and unaligned subjects showed comparable demographics at baseline. Treatment effects were significant for IDWG [−0.12 (95% CI −0.24 to 0) L] and showed decreasing non-significant trends for pre-dialysis hemodynamic parameters. Count comparison and Cox regression analysis showed no clear advantage of alignment in terms of all-cause and fluid overload-related hospitalization.ConclusionsResults from the largest sodium alignment program to date suggest positive treatment effects on volume-related and hemodynamic parameters, but no clear effect on risk of hospitalization. Well-matched control patients minimized confounding effects. Small effects and lack of significant differences may be explained by a low baseline DNa+ limiting the interventional change.
Highlights
Evidence indicates favorable effects of dialysate (DNa+) to serum sodium concentration (SNa+) alignment, results from larger sample populations are needed
We found a consistently lowering treatment effect from sodium alignment on interdialytic weight gain (IDWG), confirming that a reduction in sodium loading, by only slightly altering the DNa+ prescription, may result in a decreased urge to drink (Table 3)
The lack of effect on all-cause and fluid overload-related hospitalizations and the small effects on other parameters may be explained by a low baseline DNa+, limiting the interventional change of gradient
Summary
Evidence indicates favorable effects of dialysate (DNa+) to serum sodium concentration (SNa+) alignment, results from larger sample populations are needed For this reason, we conducted a retrospective propensity score-matched cohort study from a quality improvement project to investigate the effects of alignment on population of maintenance hemodialysis patients. Methods: At 4 participating hemodialysis (HD) clinics, patients with SNa+ lower than the standard DNa+ of 137 mEq/L who received HD with DNa+ aligned to the average of the last 4 SNa+ measurements were evaluated (clinicaltrials.gov #NCT01825590) In this retrospective data analysis, an intention-to-treat (primary) and an as-treated “intervention” (secondary) cohort were created. At variance to reported improvements on the risk of hospitalization conferred by lowering DNa+ in a nationwide quality improvement project at Fresenius Medical Care [12], and results from previously published literature, a recent analysis by the Dialysis Outcomes and Practice Patterns Study (DOPPS) reported a reduced risk for all-cause and fluid-overload related hospitalizations (using adjusted Cox regression models with time to first hospitalization as the outcome) with the use of high DNa+ in those with low SNa+ [5]
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