Effects of dialysate to serum sodium (Na+) alignment in chronic hemodialysis (HD) patients: retrospective cohort study from a quality improvement project.

BACKGROUND: Evidence 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. 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. "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. RESULTS: In 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. CONCLUSIONS: Results 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.

Performance of the Surprise Question Compared to Prediction Models in Hemodialysis Patients: A Prospective Study.

BACKGROUND: The surprise question (SQ) ("Would you be surprised if this patient were still alive in 6 or 12 months?") is used as a mortality prognostication tool in hemodialysis (HD) patients. We compared the performance of the SQ with that of prediction models (PMs) for 6- and 12-month mortality prediction. METHODS: Demographic, clinical, laboratory, and dialysis treatment indicators were used to model 6- and 12-month mortality probability in a HD patients training cohort (n = 6,633) using generalized linear models (GLMs). A total of 10 nephrologists from 5 HD clinics responded to the SQ in 215 patients followed prospectively for 12 months. The performance of PM was evaluated in the validation (n = 6,634) and SQ cohorts (n = 215) using the areas under receiver operating characteristics curves. We compared sensitivities and specificities of PM and SQ. RESULTS: The PM and SQ cohorts comprised 13,267 (mean age 61 years, 55% men, 54% whites) and 215 (mean age 62 years, 59% men, 50% whites) patients, respectively. During the 12-month follow-up, 1,313 patients died in the prediction model cohort and 22 in the SQ cohort. For 6-month mortality prediction, the GLM had areas under the curve of 0.77 in the validation cohort and 0.77 in the SQ cohort. As for 12-month mortality, areas under the curve were 0.77 and 0.80 in the validation and SQ cohorts, respectively. The 6- and 12-month PMs had sensitivities of 0.62 (95% CI 0.35-0.88) and 0.75 (95% CI 0.56-0.94), respectively. The 6- and 12-month SQ sensitivities were 0.23 (95% CI 0.002-0.46) and 0.35 (95% CI 0.14-0.56), respectively. CONCLUSION: PMs exhibit superior sensitivity compared to the SQ for mortality prognostication in HD patients.

A year-long quality improvement project on fluid management using blood volume monitoring during hemodialysis.

BACKGROUND: Inadequate removal of extracellular volume markedly increases blood pressure and contributes to high morbidity and mortality in hemodialysis patients. Advances in fluid management are needed to improve clinical outcomes. The aim of this quality improvement project was to examine the advantages of using a hematocrit-based, blood volume monitor (Crit-Line * ) for 12 months, as part of a clinic-wide, fluid management program in one dialysis facility. METHODS: Forty-five individuals were receiving hemodialysis at one facility at project initiation and are included in this analysis. Monthly averaged clinical parameters (dialysis treatment information, blood pressures, blood volume, and laboratory data) were compared from Months 1-12. Analyses were conducted overall and according to the presence/absence of hypertension at Month 1 (Baseline). Antihypertensive medication changes were assessed for patients with hypertension at Month 1. RESULTS: Average hemodialysis treatment time (+10.6 minutes, p = 0.002), eKt/V (+0.25, p < 0.001) and online clearance (+0.21, p < 0.0001) increased significantly in Month 12 versus Month 1. Average albumin levels and normalized protein catabolic rate increased from Month 1 to 12. Post-dialysis systolic blood pressure (SBP) decreased by Month 12 (p = 0.003). In hypertensive patients (SBP ≥ 140 mmHg in Month 1), there were significant differences in pre- and post-dialysis SBP between Month 1 and Month 12 (pre-hemodialysis: p = 0.02; post-hemodialysis: p = 0.0003), and antihypertensive medication use decreased in 29% of patients, while only 11% increased use. Treatment time in hypertensive patients increased by 15.4 minutes (p = 0.0005). LIMITATIONS: This was a single, clinic-wide, quality improvement project with no control group. All data analyzed were from existing clinical records, so only routinely measured clinical variables were available and missing data were possible. CONCLUSIONS: During this year-long fluid management quality improvement project, decreases in post-dialysis SBP and increases in adequacy and treatment time were observed. Patients with hypertension at Month 1 experienced reductions in pre-dialysis SBP and antihypertensive medications.

Methods and challenges for the practical application of Crit-Line™ monitor utilization in patients on hemodialysis.

The Crit-Line™ monitor measures relative changes in intravascular blood volume during hemodialysis. The device is also used to monitor hematocrit and oxygen saturation. Using this device to decrease fluid volume has yielded inconsistent results on outcome measures such as hospitalization rates, erythropoietin utilization, and blood pressure reduction. Through a year-long deployment of the Crit-Line™ monitor, the Renal Research Institute (RRI) has shown that outcomes can be improved even in a busy dialysis clinic with attention to the details of how the device is utilized. In this paper, we are proposing areas of focus and methods that if properly implemented should yield improved clinical outcomes. Strong physician approval and enthusiasm coupled with clinical staff support have been shown to be vital to the success of this device in improving clinical outcomes. Even in this setting, inadequately and improperly trained staff have been identified as almost insurmountable impediments to adequate Crit-Line™ use. Our studies have shown that in facilities where staff turnover is high, procedures must be implemented to engage and train new staff immediately upon their arrival on the dialysis floor. Other issues that may lead to improper use of the Crit-Line™ monitor include incorrect target weight assessments, failure of staff to properly monitor patients during the treatment, and the over dependency of saline administration for cramps.

Seasonal variations in mortality, clinical, and laboratory parameters in hemodialysis patients: a 5-year cohort study.

BACKGROUND AND OBJECTIVES: Mortality varies seasonally in the general population, but it is unknown whether this phenomenon is also present in hemodialysis patients with known higher background mortality and emphasis on cardiovascular causes of death. This study aimed to assess seasonal variations in mortality, in relation to clinical and laboratory variables in a large cohort of chronic hemodialysis patients over a 5-year period. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: This study included 15,056 patients of 51 Renal Research Institute clinics from six states of varying climates in the United States. Seasonal differences were assessed by chi-squared tests and univariate and multivariate cosinor analyses. RESULTS: Mortality, both all-cause and cardiovascular, was significantly higher during winter compared with other seasons (14.2 deaths per 100 patient-years in winter, 13.1 in spring, 12.3 in autumn, and 11.9 in summer). The increase in mortality in winter was more pronounced in younger patients, as well as in whites and in men. Seasonal variations were similar across climatologically different regions. Seasonal variations were also observed in neutrophil/lymphocyte ratio and serum calcium, potassium, and platelet values. Differences in mortality disappeared when adjusted for seasonally variable clinical parameters. CONCLUSIONS: In a large cohort of dialysis patients, significant seasonal variations in overall and cardiovascular mortality were observed, which were consistent over different climatic regions. Other physiologic and laboratory parameters were also seasonally different. Results showed that mortality differences were related to seasonality of physiologic and laboratory parameters. Seasonal variations should be taken into account when designing and interpreting longitudinal studies in dialysis patients.

The practical problem of improving quality in multicenter dialysis facilities.

Multifacility dialysis groups are frequently interested in improving overall quality and find that there are major differences between individual units. Upper management must consider what strategy is needed for the whole company and what strategy must be formulated by individual facilities. To make substantive changes, management must decide to adopt a new culture of true teamwork, drive out fear, and emphasize leadership and education both at the management level and in the individual unit. Both at the corporate and unit levels, leaders must be chosen who are able to recognize people who have the ability, the educational background, the enthusiasm, and the time to direct change. Empowering the individual units and individual employees to make changes and be enthusiastic about improvement is the key to success.