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Background. Our own data shows that 30% of patients in their first 90 days of treatment (tx) vs. 57% of patients greater than 90 days have an albumin of 3.8 g/dL or greater. Stage 5 CKD patients new to hemodialysis (HD) are often malnourished. Oral nutritional supplements (ONS) are often prescribed, but compliance remains a problem. To address compliance and compensate for amino acid losses that occur during HD, Kayser et al. (2002) followed 85 patients for 3 months without ONS, followed by 6 months of in-center ONS. There were significant rises in mean albumin (3.33 ± 0.32 to 3.65 ± 0.26 g/dL), prealbumin, and Subjective Global Assessment scores. To apply these findings to new HD patients, an in-center ONS program was implemented. Program. A team led by the corporate dietitian (RD) developed a policy that addressed implementation of in-center ONS. New HD patients in their first 120 days of tx with albumin of 3.5 or less and/or weight loss greater than 5% in 1 month may receive ONS with each HD treatment until albumin is equal to or greater than 3.8 g/dL, up to 40 doses/year. There are two ONS options per MD order: ProStat RC 30 ml or Nepro 8 oz liquid, each with 15, and 16.7 grams protein, respectively. All doses appear in the electronic medical record med orders to assure dose delivery and ease of tracking, and are delivered to the patient during HD by the nurse, technician, or RD. RDs, who received training via conference calls, trained clinical staff. MDs received information via the MD newsletter. Tracking outcomes. Each dose is documented with data if ONS was refused by the patient, less than 50%, or 50%-100% consumed. A monthly report provides staff with patient-specific ONS data with a count of ONS, consumption data, and albumin levels. Corporate level reports track ONS purchasing data, and clinics prescribing supplements and their volume. Finally, report design is in progress to track changes in albumin level, hospitalization, and mortality, according to amount of ONS consumed vs. patients with no ONS. Conclusion. We believe that this program design is a novel and practical way to apply research findings. The benefits are optimal use of staff time, efficient documentation, and outcomes tracking. New HD patient outcomes will also be improved. [ABSTRACT FROM AUTHOR]

Background: The annualized mortality rate of HD pts in the first 90 days of treatment is up to double the rate of patients past the first 90 days (24%-50%, Ikizler et al., 2007). We previously reported on the RightStart Program for new patients in their first 3 months, which showed improved hospitalization and mortality compared to the control group. The improved mortality was also seen long term at 1 year, which was 9 months after the intervention period was completed (Wingard et al., 2005, see table below). The SPIDER Program is the next phase of RightStart, with increased emphasis on more individualized patient education and empowerment, and innovative ways to improve outcomes, particularly for diabetes mellitus (DM) and nutrition. Approach: This case manager (CM) model provides for a CM to see all eligible new HD patients for a period of 4 months. Initial assessments specific to current HD and DM knowledge, reading level, and diabetes care are carried out. Based on this, an individualized teaching plan is developed to be carried out with the patient by the CM and multidisciplinary team (MDT). In addition, the CM tracks lab values, medical and psychosocial needs to facilitate prompt treatment by working through the MDT. On average, the CM covers 5-7 dialysis clinics, and sees patients in person 8-10 times during the 4 months with phone and family contact as needed. The individualized teaching plan employs strategies to match the patient's learning style and needs. A written patient handbook is provided to each patient and is used as a "textbook." However, other aids such as flip charts, flash cards, reading to patients, audiotapes, and videotapes are used. Implications. This program provides a process to individualize the teaching approach to overcome literacy, visual or language barriers. The CM provides continuity and coordination that prevents fragmentation of care, and staff time is efficiently focused on tasks essential for the MDT to carry out according to their expertise. The specific implementation strategies for SPIDER foot check programs and intradialytic nutritional supplements can be found in separately submitted ANNA abstracts. [ABSTRACT FROM AUTHOR]

Background: ESRD patients with diabetes are clearly at higher risk for foot problems. Studies show that peripheral vascular disease (PVD) and peripheral neuropathy (PN) are much more common in diabetes patients on dialysis than in patients without renal insufficiency. Since PVD and PN contribute to the development of foot problems, diabetes patients on dialysis are at an even-greater risk of developing non-healing foot ulcers leading to amputation and increased morbidity and mortality. To prevent these foot problems, daily foot care and inspection is recommended for all people with diabetes. However, compliance with home foot checks and obtaining therapeutic shoes is often low. Approach: To reduce foot complications, we implemented within the SPIDER program in-center interventions of routine foot checks, patient education and referrals for therapeutic shoes. Case Managers were trained to perform foot exams per a corporate policy/procedure, slide presentation, instructor demonstration and participant return demonstration. The comprehensive foot exam included skin assessment, checking pedal pulses, and sensory testing. Patient handouts were specifically designed for teaching daily foot inspection, lubrication, and safety. Electronic documentation and reporting systems were set up to track foot check completion and actions for follow-up. As a result, on average, 85% or more of foot checks were completed monthly in the dialysis clinics as compared to only sporadic or no foot checks being done. Foot problems were identified promptly and patients were referred to appropriate specialists. Patients that qualified for therapeutic shoes were evaluated and fit when applicable. Implications: The patient/staff awareness and satisfaction in finding foot problems through an efficient and manageable process has been significant. Increasing attention to the diabetic foot can benefit in the areas of prevention, early identification of problems, and prompt referrals that can ultimately prevent amputations and subsequently decrease mortality in this high-risk ESRD population. [ABSTRACT FROM AUTHOR]

Purpose: Mortality among first-year hemodialysis (HD) patients remains unacceptably high. To address this problem, we estimate the proportions of early HD deaths that are potentially preventable by modifying known risk factors., Methods: We included 15,891 HD patients (within 60 days of starting HD) from 21 countries in the Dialysis Outcomes and Practice Patterns Study (1996-2015), a prospective cohort study. Using Cox regression adjusted for potential confounders, we estimated the fraction of first-year deaths attributable to one or more of twelve modifiable risk factors (the population attributable fraction, AF) identified from the published literature by comparing predicted survival based on risk factors observed vs counterfactually set to reference levels., Results: The highest AFs were for catheter use (22%), albumin <3.5 g/dL (19%), and creatinine <6 mg/dL (12%). AFs were 5%-9% for no pre-HD nephrology care, no residual urine volume, systolic blood pressure <130 or ≥160 mm Hg, phosphorus <3.5 or ≥5.5 mg/dL, hemoglobin <10 or ≥12 g/dL, and white blood cell count >10,000/μL. AFs for ferritin, calcium, and PTH were <3%. Overall, 65% (95% CI: 59%-71%) of deaths were attributable to these 12 risk factors. Additionally, the AF for C-reactive protein >10 mg/L was 21% in facilities where it was routinely measured., Conclusion: A substantial proportion of first-year HD deaths could be prevented by successfully modifying a few risk factors. Highest priorities should be decreasing catheter use and limiting malnutrition/inflammation whenever possible., Competing Interests: Friedrich K Port has a consultancy contract with Arbor Research Collaborative for Health. Hal Morgenstern is consultant at Arbor Research Collaborative for Health. Takeshi Hasagawa has consulted for Kyowa Hakko Kirin, received research funding from JSPS KAKENHI (Grant Number 15K00877) and received speaker honoraria from Kyowa Hakko Kirin, Chugai Pharmaceutical, Torii Pharmaceutical, and Daiichi-Sankyo Pharmaceutical. Raymond Vanholder has received travel support and speaker’s honoraria from B. Braun and Nikisho. Michel Jadoul has served as a consultant for Astellas, MSD, Vifor Fresenius Medical Care Renal Pharma, received grant/research support from Amgen, Astra-Zeneca, Janssen-Cilag, MSD, Otsuka, Roche, been a speaker for AbbVie, Amgen, Menarini, MSD, Vifor Fresenius Medical Care Renal Pharma, received travel compensation from Amgen; all monies paid to institution including non-financial support from Sanofi-Genzyme, outside the submitted work. Elke Schaeffner reports speaker honorarium from Fresenius Medical Care, Fresenius Kabi, Siemens healthineers and grants from E.N.D.I foundation and DDnÄ, outside the submitted work. Angelo Karaboyas, Bruce M. Robinson, Ronald L Pisoni, Brian A. Bieber are employees of Arbor Research Collaborative for Health, which administers the DOPPS. Angelo Karaboyas reports grants from Akebia Therapeutics, Amgen, AstraZeneca, Bard Peripheral Vascular, Baxter Healthcare, Bayer Yakuhin, Chugai Pharmaceutical, Fresenius Medical Care Asia-Pacific, Japanese Society for Peritoneal Dialysis, JMS Co, Kidney Research UK, Kidney Foundation Japan, Kissei Pharmaceutical Co, Kyowa Kirin Co, MEDICE Arzneimittel Pütter GmbH & Co KG, Nikkiso, ONO Pharmaceutical Co, Sanofi-Aventis Deutschland GmbH, Terumo Corporation, Torii Pharmaceutical Co, Vifor-Fresenius Medical Care Renal Pharma Ltd, during the conduct of the study. The authors report no other conflicts of interest in this work., (© 2020 Karaboyas et al.)

Rationale & Objective: Missed hemodialysis (HD) treatments not due to hospitalization have been associated with poor clinical outcomes and related in part to treatment nonadherence. Using data from the Dialysis Outcomes and Practice Patterns Study (DOPPS) phase 5 (2012-2015), we report findings from an international investigation of missed treatments among patients prescribed thrice-weekly HD., Study Design: Prospective observational study., Setting & Participants: 8,501 patients participating in DOPPS, on HD therapy for more than 120 days, from 20 countries. Longitudinal and cross-sectional analyses were performed based on the 4,493 patients from countries in which 4-month missed treatment risk was > 5%., Predictors: The main predictor of patient outcomes was 1 or more missed treatments in the 4 months before DOPPS phase 5 enrollment; predictors of missed treatments included country, patient characteristics, and clinical factors., Outcomes: Mortality, hospitalization, laboratory measures, patient-reported outcomes, and 4-month missed treatment risk., Analytical Approach: Outcomes were assessed using Cox proportional hazards, logistic, and linear regression, adjusting for case-mix and country., Results: The 4-month missed treatment risk varied more than 50-fold across all 20 DOPPS countries, ranging from < 1% in Italy and Japan to 24% in the United States. Missed treatments were more likely with younger age, less time on dialysis therapy, shorter HD treatment time, lower Kt/V, longer travel time to HD centers, and more symptoms of depression. Missed treatments were positively associated with all-cause mortality (HR, 1.68; 95% CI, 1.37-2.05), cardiovascular mortality, sudden death/cardiac arrest, hospitalization, serum phosphorus level > 5.5mg/dL, parathyroid hormone level > 300pg/mL, hemoglobin level < 10g/dL, higher kidney disease burden, and worse general and mental health., Limitations: Possible residual confounding; temporal ambiguity in the cross-sectional analyses., Conclusions: In the countries with a 4-month missed treatment risk > 5%, HD patients were more likely to die, be hospitalized, and have poorer patient-reported outcomes and laboratory measures when 1 or more missed treatments occurred in a 4-month period. The large variation in missed treatments across 20 nations suggests that their occurrence is potentially modifiable, especially in the United States and other countries in which missed treatment risk is high., (Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.)

Background and Objectives: Anemia management changed substantially among dialysis patients in the United States around the time of implementation of the new Centers for Medicare & Medicaid Services bundled payment system and erythropoiesis-stimulating agent (ESA) label change in 2011. Among these, average ferritin levels increased dramatically and have remained high since; this study sought to gain understanding of this sustained rise in ferritin levels., Design, Setting, Participants, & Measurements: Trends in mean ferritin, hemoglobin, IV iron dose, and ESA dose from 2009 to 2013 were examined in 9735 patients from 91 United States Dialysis Outcomes and Practice Patterns Study facilities. Linear mixed models were used to assess the extent to which intravenous (IV) iron and ESA dose accounted for patients' changes in ferritin over time., Results: Mean ESA dose and hemoglobin levels declined throughout the study. Mean IV iron dose increased from 210 mg/mo in 2009-2010 to a peak of 280 mg/mo in 2011, then declined back to 200 mg/mo and remained stable from 2012 to 2013. Mean ferritin increased from 601 ng/ml in the third quarter of 2009 to 887 ng/ml in the first quarter of 2012; models suggest that higher IV iron dosing was a primary determinant during 2011, but lower ESA doses contributed to the sustained high ferritin levels thereafter. In a subset of 17 facilities that decreased IV iron dose in 2011, mean ferritin rose by 120 ng/ml to 764 ng/ml, which appeared to be primarily due to ESA reduction. Together, changes in IV iron and ESA doses accounted for 46% of the increase in ferritin over the study period., Conclusions: In contrast to expectations, the rise in average IV iron dose did not persist beyond 2011. The sustained rise in ferritin levels in United States dialysis patients after policy changes in 2011, to average levels well in excess of 800 ng/ml, appeared to be partly due to reductions in ESA dosing and not solely IV iron dosing practices. The effect of these changes in ferritin on health outcomes requires further investigation., (Copyright © 2015 by the American Society of Nephrology.)

Most patients with end-stage renal disease depend on intermittent hemodialysis to maintain levels of serum potassium and other electrolytes within a normal range. However, one of the challenges has been the safety of using a low-potassium dialysate to achieve that goal, given the concern about the effects that rapid and/or large changes in serum potassium concentrations may have on cardiac electrophysiology and arrhythmia. Additionally, in this patient population, there is a high prevalence of structural cardiac changes and ischemic heart disease, making them even more susceptible to acute arrhythmogenic triggers. This concern is highlighted by the knowledge that about two-thirds of all cardiac deaths in dialysis are due to sudden cardiac death and that sudden cardiac death accounts for 25% of the overall death for end-stage renal disease. Developing new approaches and practice standards for potassium removal during dialysis, as well as understanding other modifiable triggers of sudden cardiac death, such as other electrolyte components of the dialysate (magnesium and calcium), rapid ultrafiltration rates, and safety of a number of medications (ie, drugs that prolong the QT interval or use of digoxin), are critical in order to decrease the unacceptably high cardiac mortality experienced by hemodialysis-dependent patients., (Published by Elsevier Inc.)

Background: Patterns of early outcomes in peritoneal dialysis (PD) are not well studied and dialysis providers need to establish a baseline of key outcomes for continuous quality improvement initiatives., Study Design: Retrospective cohort study., Setting & Participants: Incident PD patients from Fresenius Medical Care, North America from January 1 through December 31, 2009., Factors: Case-mix, comorbid illness, and baseline laboratory values., Outcomes: Death, hospitalization, peritonitis, and switch to hemodialysis (HD) within the first year on PD therapy., Measurements: Event rates and outcome predictors., Results: Of 1,677 incident PD patients, 1,313 started on PD therapy and 367 switched from HD therapy within the first 90 days. Normalized first-year event rates for mortality, switch to HD therapy, peritonitis, and hospitalization were 10, 27, 42, and 128 per 100 patient-years, respectively. 336 of 463 (72.6%) first peritonitis episodes and 637 of 939 (67.8%) first hospitalizations occurred within the first 6 months of PD treatment. Black race, higher body mass index, non-Hispanic ethnicity, peripheral vascular disease, and low weekly Kt/V associated with peritonitis risk. Dialysis vintage, female sex, diabetes, congestive heart failure, peripheral vascular disease, and history of limb amputation along with lower laboratory values for albumin, hemoglobin, and phosphorus and weekly Kt/V associated with hospitalization. Switchers to HD therapy (n=350) used central venous catheters 81.4% of the time as initial access (still 78.3% at 90 days later) because of lack of permanent access., Limitations: Residual confounding from unmeasured variables and exclusion of patients with a training day but who never started home PD therapy., Conclusions: Despite low first-year mortality, incident PD patients had high morbidity, particularly within the first 3-6 months. Increased focus to identify patients at greatest risk for peritonitis and hospitalization, as well as evaluation of care processes and implementation of preventive strategies, is required. Access planning for transition to HD therapy needs more attention, even during the first PD year., (Copyright © 2014 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.)

We reviewed a number of prospective randomized and multiple retrospective cohort studies of different dialysis prescriptions: longer dialysis time, at a frequency of at least three times a week, or a frequency of daily hemodialysis with a shorter dialysis time. Interestingly, the retrospective analyses have generally found significant survival benefits in the intensive dialysis groups, whereas more modest effects were observed in the prospective randomized controlled trials. The reason for this discrepancy may be related to the retrospective nature of the studies and possible selection bias; for example, the patients who were prescribed more frequent dialysis may have had more difficulties with volume control or high blood pressure. In contrast, the randomized controlled trials of increased dialysis frequency, which have shown indirect and modest benefits in complex coprimary end points, have small sample sizes and are plagued with difficulties in recruitment and compliance with the randomly allocated more frequent dialysis. This review, which attempts to balance the potential benefits of more frequent dialysis with the burden on the patient's lifestyle, an increased risk of access malfunction, as well as societal costs of such intensive dialysis prescriptions, concludes in favor of the conventional three times per week dialysis (at a minimum) but at longer dialysis times than is currently prescribed based on the Kt/Vurea metric alone.

African Americans require higher doses of erythropoiesis-stimulating agents (ESAs) during dialysis to manage anemia, but the influence of sickle cell trait and other hemoglobinopathy traits on anemia in dialysis patients has not been adequately evaluated. We performed a cross-sectional study of a large cohort of adult African-American hemodialysis patients in the United States to determine the prevalence of hemoglobinopathy traits and quantify their influence on ESA dosing. Laboratory and clinical data were obtained over 6 months in 2011. Among 5319 African-American patients, 542 (10.2%) patients had sickle cell trait, and 129 (2.4%) patients had hemoglobin C trait; no other hemoglobinopathy traits were present. Sickle cell trait was more common in this cohort than the general African-American population (10.2% versus 6.5%-8.7%, respectively, P<0.05). Among 5002 patients (10.3% sickle cell trait and 2.4% hemoglobin C trait) receiving ESAs, demographic and clinical variables were similar across groups, with achieved hemoglobin levels being nearly identical. Patients with hemoglobinopathy traits received higher median doses of ESA than patients with normal hemoglobin (4737.4 versus 4364.1 units/treatment, respectively, P=0.02). In multivariable analyses, hemoglobinopathy traits associated with 13.2% more ESA per treatment (P=0.001). Within subgroups, sickle cell trait patients received 13.2% (P=0.003) higher dose and hemoglobin C trait patients exhibited a similar difference (12.9%, P=0.12). Sensitivity analyses using weight-based dosing definitions and separate logistic regression models showed comparable associations. Our findings suggest that the presence of sickle cell trait and hemoglobin C trait may explain, at least in part, prior observations of greater ESA doses administered to African-American dialysis patients relative to Caucasian patients.

Increased markers of oxidative stress and acute-phase inflammation are prevalent in patients undergoing maintenance hemodialysis therapy (MHD), and are associated with increased mortality and hospitalization rates and decreased erythropoietin responsiveness. No adequately powered studies have examined the efficacy of antioxidant therapies on markers of inflammation and oxidative stress. We tested the hypothesis that oral antioxidant therapy over 6 months would decrease selected biomarkers of acute-phase inflammation and oxidative stress and improve erythropoietic response in prevalent MHD patients. In total, 353 patients were enrolled in a prospective, placebo-controlled, double-blind clinical trial and randomly assigned to receive a combination of mixed tocopherols (666 IU/d) plus α-lipoic acid (ALA; 600 mg/d) or matching placebos for 6 months (NCT00237718); 238 patients completed the study. High-sensitivity C-reactive protein (hsCRP) and IL-6 concentration were measured as biomarkers of systemic inflammation, and F2 isoprostanes and isofurans were measured as biomarkers of oxidative stress. The groups did not significantly differ at baseline. At 3 and 6 months, the treatment had no significant effect on plasma hsCRP, IL-6, F2 isoprostane, or isofuran concentrations and did not improve the erythropoietic response. No major adverse events were related to the study drug, and both groups had similar mortality and hospitalization rates during the study. In conclusion, the administration of mixed tocopherols and ALA was generally safe and well tolerated, but did not influence biomarkers of inflammation and oxidative stress or the erythropoietic response.

Purpose of Review: This review examines recent advances in understanding of how clinical outcomes for hemodialysis patients may be improved by achieving longer or more frequent treatment times, lower ultrafiltration rates (UFRs), improving nutritional status, and individualizing dialysate composition. This review also discusses the controversy related to timing of dialysis initiation., Recent Findings: Many observational studies and several randomized controlled trials indicate longer dialysis treatment times, particularly nocturnal dialysis, and/or more frequent dialysis improve morbidity and mortality. Recent evidence also suggests that lower UFR and more consistent achievement of 'dry weight' may help minimize the damage from myocardial stunning and chronic volume overload that occurs in the majority of patients who receive conventional hemodialysis during the day with a standard schedule of 3-5 h, 3 times a week. Other aspects of the dialysis procedure such as appropriate estimated glomerular filtration rate for dialysis initiation and individualizing dialysate composition may also minimize cardiovascular risk. Finally, several studies have highlighted the benefits of oral nutritional supplementation (ONS) during dialysis., Summary: Greater treatment times per week with slower UFR, consistent attainment of 'dry weight', individualized dialysate prescriptions, and administration of ONS to malnourished patients are likely to reduce hospitalizations and improve survival in this high-risk population of end-stage renal disease patients.

Morbidity, hospitalizations, and costs for the treatment of individuals with end-stage renal disease are simply not improving at a rate that is acceptable to many physicians and dialysis providers in the United States. Various conferences and papers have suggested what processes need to become part of the dialysis prescription to accelerate change. Controlling cardiovascular disease is a part of that change, and controlling extra-cellular volume (ECV) is necessary to accomplish this. Three dialysis providers joined in a quality initiative to objectively assess the ultrafiltration process and measure "normalized" ECV, with the outcome objective to decrease ECV-related hospitalizations. The results show a decrease in ECV-related hospitalizations by 50%. The model of dialysis prescription needs to now change to Kt/V + objective ECV control.

Background: Hemodialysis (HD) access is considered a critical and actionable determinant of morbidity, with a growing literature suggesting that initial HD access type is an important marker of long-term outcomes. Accordingly, we examined HD access during the incident dialysis period, focusing on infection risk and successful fistula creation during the first dialysis year., Study Design: Longitudinal cohort., Setting & Participants: All US adults admitted to Fresenius Medical Care North America facilities within 15 days of first maintenance dialysis session between January 1 and December 31, 2007., Predictor: Vascular access type at HD therapy initiation., Outcomes: Vascular access type at 90 days and at the end of the first year on HD therapy, bloodstream infection within the first year by access type, and catheter complication rate., Results: Of 25,003 incident dialysis patients studied, 19,622 (78.5%) initiated dialysis with a catheter; 4,151 (16.6%), with a fistula; and 1,230 (4.9%), with a graft. At 90 days, 14,105 (69.7%) had a catheter, 4,432 (21.9%) had a fistula, and 1,705 (8.4%) had a graft. Functioning fistulas and grafts at dialysis therapy initiation had first-year failure rates of 10% and 15%, respectively. Grafts were seldom replaced by fistulas (3%), whereas 7,064 (47.6%) of all patients who initiated with a catheter alone still had only a catheter at 1 year. Overall, 3,327 (13.3%) patients had at least one positive blood culture during follow-up, with the risk being similar between the fistula and graft groups, but approximately 3-fold higher in patients with a catheter (P<0.001 for either comparison). Nearly 1 in 3 catheters (32.5%) will require tissue plasminogen activator use by a median of 41 days, with 59% requiring more than one tissue plasminogen activator administration., Limitations: Potential underestimation of bacteremia because follow-up blood culture results did not include samples sent to local laboratories., Conclusions: In a large and representative population of incident US dialysis patients, catheter use remains very high during the first year of HD care and is associated with high mechanical complication and bloodstream infection rates., (Copyright © 2012 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.)

Background: Insufficient clinical data exist to determine whether provision of oral nutritional supplements during dialysis can improve survival in hypoalbuminemic maintenance hemodialysis patients., Study Design: Retrospective matched-cohort study., Setting & Participants: All oral nutritional supplement program-eligible in-center maintenance hemodialysis patients with albumin level ≤3.5 g/dL in quarter 4 of 2009 without oral nutritional supplements in the prior 90 days at Fresenius Medical Care, North America facilities., Quality Improvement Plan: Monitored intradialytic oral nutritional supplements were provided to eligible maintenance hemodialysis patients upon physician order, to continue for a year or until serum albumin level was ≥4.0 g/dL., Outcome: Mortality (including deaths and withdrawals), followed up until December 31, 2010., Measurements: Both an intention-to-treat (ITT) and an as-treated analysis was performed using a 1:1 geographic region and propensity score-matched study population (using case-mix, laboratory test, access type, 30-day prior hospitalization, and incident patient status) comparing patients treated with intradialytic oral nutritional supplements with usual-care patients. Cox models were constructed, unadjusted and adjusted for facility standardized mortality ratio and case-mix and laboratory variables., Results: The ITT and as-treated analyses both showed lower mortality in the oral nutritional supplement group. The conservative ITT models with 5,227 matched pairs had 40% of controls subsequently receiving oral nutritional supplements after January 1, 2010 (because many physicians delayed participation), with comparative death rates of 30.1% versus 30.4%. The corresponding as-treated (excluding crossovers) death rates for 4,289 matched pairs were 30.9% versus 37.3%. The unadjusted ITT mortality HR for oral nutritional supplement use was 0.95 (95% CI, 0.88-1.01), and the adjusted HR was 0.91 (95% CI, 0.85-0.98); the corresponding as-treated HRs were 0.71 (95% CI, 0.66-0.76) and 0.66 (95% CI, 0.61-0.71) before and after adjustment, respectively., Limitations: Limited capture of oral nutritional supplement intake outside the facility and potential residual confounding from unmeasured variables, such as dietary intake., Conclusions: Maintenance hemodialysis patients with albumin levels ≤3.5 g/dL who received monitored intradialytic oral nutritional supplements showed survival significantly better than similar matched patient controls, with the as-treated analysis highlighting the potentially large effect of this strategy in clinical practice., (Copyright © 2012 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.)

Staphylococcus bacteremia is a common and life-threatening medical emergency, but it is treatable with appropriate antibiotic therapy. To identify opportunities that may reduce morbidity and mortality associated with S. aureus, we analyzed data from 293,094 chronic hemodialysis outpatients to characterize practices of antibiotic selection. In the study population, the overall rate of bacteremia was 15.4 per 100 outpatient-years; the incidence rate for methicillin-sensitive (MSSA) was 2.1 per 100 outpatient-years, and the incidence rate for methicillin-resistant (MRSA) S. aureus was 1.9 per 100 outpatient-years. One week after the collection of the index blood culture, 56.1% of outpatients with MSSA bacteremia were receiving vancomycin, and 16.7% of outpatients with MSSA were receiving cefazolin. Among MSSA-bacteremic patients who did not die or get hospitalized 1 week after blood culture collection, use of cefazolin was associated with a 38% lower risk for hospitalization or death compared with vancomycin (adjusted HR=0.62, 95% CI=0.46-0.84). In conclusion, vancomycin is commonly used to treat MSSA bacteremia in outpatients receiving chronic dialysis, but there may be more risk of treatment failure than observed among those individuals who receive a β-lactam antibiotic such as cefazolin.

A previous commentary pointed out that the renal community has led American healthcare in the development and continuous improvement of quality outcomes. However, survival, hospitalization, and quality of life for US dialysis patients is still not optimal. This follow-up commentary examines the obstacles, gaps, and metrics that characterize this unfortunate state of affairs. It posits that current paradigms are essential contributors to quality outcomes but are no longer sufficient to improve quality. New strategies are needed that arise from a preponderance of evidence, in addition to beyond a reasonable doubt standard. This work offers an action plan that consists of new pathways of care that will lead to improved survival, fewer hospitalizations and rehospitalizations, and better quality of life for patients undergoing dialysis therapy. Nephrologists in collaboration with large and small dialysis organizations and other stakeholders, including the Centers for Medicare and Medicaid Services, can implement these proposed new pathways of care and closely monitor their effectiveness. We suggest that our patients deserve nothing less and must receive even more.

Whether the duration of hemodialysis treatments improves outcomes remains controversial. Here, we evaluated survival and clinical changes associated with converting from conventional hemodialysis (mean=3.75 h/treatment) to in-center nocturnal hemodialysis (mean=7.85 h/treatment). All 959 consecutive patients who initiated nocturnal hemodialysis for the first time in 77 Fresenius Medical Care facilities during 2006 and 2007 were eligible. We used Cox models to compare risk for mortality during 2 years of follow-up in a 1:3 propensity score-matched cohort of 746 nocturnal and 2062 control patients on conventional hemodialysis. Two-year mortality was 19% among nocturnal hemodialysis patients compared with 27% among conventional patients. Nocturnal hemodialysis associated with a 25% reduction in the risk for death after adjustment for age, body mass index, and dialysis vintage (hazard ratio=0.75, 95% confidence interval=0.61-0.91, P=0.004). With respect to clinical features, interdialytic weight gain, albumin, hemoglobin, dialysis dose, and calcium increased on nocturnal therapy, whereas postdialysis weight, predialysis systolic blood pressure, ultrafiltration rate, phosphorus, and white blood cell count declined (all P<0.001). In summary, notwithstanding the possibility of residual selection bias, conversion to treatment with nocturnal hemodialysis associates with favorable clinical features, laboratory biomarkers, and improved survival compared with propensity score-matched controls. The potential impact of extended treatment time on clinical outcomes while maintaining a three times per week hemodialysis schedule requires evaluation in future clinical trials.

The rate of rehospitalization is at a critical level. Twenty percent of all Medicare patients are rehospitalized within 30 days of discharge, and this rate is even higher (36%) for end-stage renal disease patients. Dialysis-dependent patients are commonly discharged from the hospital with a decline in various health measures (such as hemoglobin, albumin, and estimated dry weight) when compared to pre-hospital values, making the common response to resume previous orders" in the outpatient setting inadequate. Both quality of care and financial penalties by the Centers for Medicare & Medicaid Services have set the stage for partnerships between dialysis providers and hospitals to develop strategies to reduce readmissions for ESRD patients, and provide for the "RightReturn" to the outpatient setting with resumption of their daily lives at home in optimal health.

Background and Objectives: Approximately one million Americans initiated chronic dialysis over the past decade; the first-year mortality rate reported by the U.S. Renal Data System was 19.6% in 2007. This estimate has historically excluded the first 90 days of chronic dialysis., Design, Setting, Participants, & Measurements: To characterize the mortality and hospitalization risks for patients starting chronic renal replacement therapy, we followed all patients initiating dialysis in 1733 facilities throughout the United States (n = 303,289). Mortality and hospitalizations within the first 90 days were compared with outcomes after this period, and the results were analyzed. Standard time-series analyses were used to depict the weekly risk estimates for each outcome., Results: Between 1997 and 2009, >300,000 patients initiated chronic dialysis and were followed for >35 million dialysis treatments; the highest risk for morbidity and mortality occurred in the first 2 weeks of treatment. The initial 2-week risk of death for a typical dialysis patient was 2.72-fold higher, and the risk of hospitalization was 1.95-fold higher when compared to a patient who survived the first year of chronic dialysis (week 53 after initiation). Similarly, over the first 90 days, the risk of mortality and hospitalization remained elevated. Thereafter, between days 91 and 365, these risks decreased considerably by more than half. Surviving these first weeks of dialysis was most associated with the type of vascular access. Initiating dialysis with a fistula was associated with a decreased early death risk by 61%, whereas peritoneal dialysis decreased the risk by 87%., Conclusions: The first 2 weeks of chronic dialysis are associated with heightened mortality and hospitalization risks, which remain elevated over the ensuing 90 days.

Background and Objectives: Referring hemodialysis patients for elective access angiography and percutaneous transluminal angioplasty (PTA) is commonly done to prevent access failure, yet the effectiveness of this procedure remains unclear. DESIGN, SETTING, PARTICIPANTS, & MEASURES: An observational matched cohort analysis among 40,132 Medicare beneficiaries receiving hemodialysis with a fistula or graft was performed. Cox regression was used to determine whether access intervention was associated with improved 1-year access survival., Results: Nonsurgical access intervention was found to be frequent at a rate of 20.9 procedures per 100 access years. In the 1-year period after intervention using angiography and PTA, the overall access failure rate was 53.7 per 100 access years in the intervention group and 49.6 in the nonintervention group (HR = 1.02; 95% CI, 0.96 to 1.08). Similar findings were also seen when the analysis was repeated in only fistulas (HR = 1.06; 95% CI, 0.98 to 1.15) and grafts (HR = 0.95; 95% CI, 0.86 to 1.05). In patients with a low intra-access flow rate (HR = 0.86; 95% CI, 0.75 to 0.99) or a new access (HR = 0.79; 95% CI, 0.71 to 0.89), angiography and PTA significantly increased access survival when compared with nonintervention (P for interaction was <0.0001). Angiography-PTA-related upper-extremity hematoma, vessel injury, or embolism-thrombosis occurred in 1.1% of all patients., Conclusions: Access characteristics significantly modify the survival benefits of angiography and PTA intervention where the benefits of these interventions are most seen in newer accesses or accesses with insufficient flow.

Background: Patients' education about transplant, hemodialysis (HD), peritoneal dialysis (PD), and conservative care often is provided by nephrologists as needed and occurs as time allows., Study Design: Quality improvement report., Setting & Participants: Attendees of a national treatment options program (TOPs) who initiated long-term dialysis therapy (median, 3.4 months) at Fresenius Medical Care, North America facilities throughout 2008 were compared with period-prevalent incident patients receiving usual care., Quality Improvement Plan: Standardized predialysis treatment options education., Outcomes: Rates of opting for PD modality, arteriovenous HD access at initiation, and early (90-day) mortality risk., Measurements: Logistic regression (for choice of PD and HD access type) and Cox models (for early mortality) were constructed, including a 1:1 matched cohort. A post hoc sensitivity analysis also compared a propensity score-matched cohort., Results: 3,165 TOPs attendees (10.5% of 30,217 incident patients admitted between January 1 and December 31, 2008), were younger, more likely to be white, and had slightly larger body surface area. The unadjusted OR for TOPs attendees for selecting PD therapy was 8.45 (95% CI, 7.63-9.37) with a case-mix plus laboratory-adjusted OR of 5.13 (95% CI, 3.58-7.35). For patients who opted for in-center HD therapy, the OR was 2.14 (95% CI, 1.96-2.33) and adjusted OR was 2.06 (95% CI, 1.88-2.26) for starting with a fistula or graft. The unadjusted early mortality HR was 0.51 (95% CI, 0.43-0.60) and case-mix plus laboratory-adjusted adjusted HR was 0.61 (95% CI, 0.50-0.74) for TOPs attendees (all outcomes, P < 0.001). These results were consistent in the 1:1 matched analysis and propensity score-matched analysis., Limitations: It is possible that physicians who referred to these programs were more likely to prescribe PD therapy or place arteriovenous accesses. Motivated, treatment-adherent patients (who would have better outcomes) may have self-selected to attend education sessions., Conclusion: Attending an options class predialysis was associated with more frequent selection of home dialysis, fewer tunneled HD catheters, and lower mortality risk during the first 90 days of dialysis therapy., (Copyright © 2011 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.)

The ability to offer repetitive hemodialysis for treatment of chronic kidney failure has now reached its half-century anniversary. Although millions of patients have benefited from this life-extending procedure, current results in the United States have now stagnated with only small annual improvements in survival and continued high hospitalization rates. Recognition that this stagnation may be, at least in part, the result of inadequacies of current and prior paths utilized in dialysis treatment has led to the concept that dialysis therapy is at a crossroads and that new paths need to be articulated, explored, and applied. This article proposes some of these new paths and their rationale. Two elements of the new paths are emphasized: avoidance of indwelling catheters for vascular access and meticulous attention to control of extracellular volume and mitigation of left ventricular hypertrophy and fibrosis. It is postulated that progress in these two areas, along with continued attention to other elements embodied in the new and old paths, will unlock the stagnation in outcomes of dialysis therapy of end-stage kidney failure and allow it to realize its full potential of prolonging life and alleviating disability.

Background and Objectives: Higher mortality risk reported with reuse versus single use of dialyzers is potentially related to reuse reagents that modify membrane surface characteristics and the blood-membrane interface. A key mechanism may involve stimulation of an inflammatory response., Design, Setting, Participants, & Measurements: In a prospective crossover design, laboratory markers and mortality from 23 hemodialysis facilities abandoning reuse with peracetic acid mixture were tracked. C-reactive protein (CRP), white blood cell (WBC) count, albumin, and prealbumin were measured for 2 consecutive months before abandoning reuse and subsequently within 3 and 6 months on single use. Survival models were utilized to compare the 6-month period before abandoning reuse (baseline) and the 6-month period on single use of dialyzers after a 3-month "washout period.", Results: Patients from baseline and single-use periods had a mean age of approximately 63 years; 44% were female, 54% were diabetic, 60% were white, and the mean vintage was approximately 3.2 years. The unadjusted hazard ratio for death was 0.70 and after case-mix adjustment was 0.74 for single use compared with reuse. Patients with CRP≥5 mg/L during reuse (mean CRP=26.6 mg/ml in April) declined on single use to 20.2 mg/L by August and 20.4 mg/L by November. WBC count declined slightly during single use, but nutritional markers were unchanged., Conclusions: Abandonment of peracetic-acid-based reuse was associated with improved survival and lower levels of inflammatory but not nutritional markers. Further study is needed to evaluate a potential link between dialyzer reuse, inflammation, and mortality.

Limited health literacy is common in the United States and associates with poor clinical outcomes. Little is known about the effect of health literacy in patients with advanced kidney disease. In this prospective cohort study we describe the prevalence of limited health literacy and examine its association with the risk for mortality in hemodialysis patients. We enrolled 480 incident chronic hemodialysis patients from 77 dialysis clinics between 2005 and 2007 and followed them until April 2008. Measured using the Rapid Estimate of Adult Literacy in Medicine, 32% of patients had limited (<9th grade reading level) and 68% had adequate health literacy (≥9th grade reading level). Limited health literacy was more likely in patients who were male and non-white and who had fewer years of education. Compared with adequate literacy, limited health literacy associated with a higher risk for death (HR 1.54; 95% CI 1.01 to 2.36) even after adjustment for age, sex, race, and diabetes. In summary, limited health literacy is common and associates with higher mortality in chronic hemodialysis patients. Addressing health literacy may improve survival for these patients.

Background and Objectives: Conversion from central venous catheters to a graft or a fistula is associated with lower mortality risk in long-term hemodialysis (HD) patients; however, a similar association with hospitalization risk remains to be elucidated., Design, Setting, Participants, & Measurements: We conducted a prospective observational study all maintenance in-center HD patients who were treated in Fresenius Medical Care, North America legacy facilities; were alive on January 1, 2007; and had baseline laboratory data from December 2006. Access conversion (particularly from a catheter to a fistula or a graft) during the 4-month period from January 1 through April 30, 2007, was linked using Cox models to hospitalization risk during the succeeding 1-year follow-up period (until April 30, 2008)., Results: The cohort (N = 79,545) on January 1, 2007 had 43% fistulas, 29% catheters, and 27% grafts. By April 30, 2007, 70,852 patients were still on HD, and among 19,792 catheters initially, only 10.3% (2045 patients) converted to either a graft or a fistula. With catheters as reference, patients who converted to grafts/fistulas had similar adjusted hazard ratios (0.69) as patients on fistulas (0.71), while patients with fistulas/grafts who converted to catheters did worse (1.22), all P < 0.0001., Conclusions: Catheters remain associated with the greatest hospitalization risk. Conversion from a catheter to either graft or fistula had significantly lower hospitalization risk relative to keeping the catheter. Prospective studies are needed to determine whether programs that reduce catheters will decrease hospitalization risk in HD patients.

Background and Objectives: The benefits and risks of aggressive glycemic control in diabetes mellitus complicated by end-stage kidney failure remain uncertain but have importance because of the large patient population with inferior overall prognosis. Recent large observational studies with differing methodologies reached somewhat contrasting conclusions regarding the association of hemoglobin A1c with survival in diabetic chronic hemodialysis patients., Design, Setting, Participants, & Measurements: This study supplements the authors' previous analysis (which found no correlation) by extending the follow-up period to 3 years and using time-dependent survival models with repeated measures. Among 24,875 nationally distributed study patients, 94.5% had type 2 diabetes, allowing additional analysis in the subset with type 1 diabetes. Data were collected at baseline and every quarter to a maximum of 3 years' follow-up., Results: Adjusted standard and time-dependent Cox models indicated that only extremes of glycemia were associated with inferior survival. There was no effect modification by serum albumin levels, a marker of protein nutrition status, and no trend associated with random glucose measurements in a post hoc analysis. In type 1 diabetic patients, upper extreme hemoglobin A1c values indicated lower survival risk., Conclusions: Sustained extremes of glycemia were only variably and weakly associated with decreased survival in this population. In the absence of randomized, controlled trials, these results suggest that aggressive glycemic control cannot be routinely recommended for all diabetic hemodialysis patients on the basis of reducing mortality risk. Physicians are encouraged to individualize glycemic targets based on potential risks and benefits in diabetic ESRD patients.

The safety of prescribing digoxin in ESRD is unknown. Hypokalemia, which frequently occurs among dialysis patients, may enhance the toxicity of digoxin. Here, we analyzed the association between digoxin prescription and survival in a retrospective cohort using covariate- and propensity score-adjusted Cox models to minimize the potential for confounding by indication. Among 120,864 incident hemodialysis patients, digoxin use associated with a 28% increased risk for death (hazard ratio [HR] 1.28; 95% confidence interval 1.25 to 1.31). Increasing serum digoxin level was also significantly associated with mortality (HR 1.19 per ng/ml increase; 95% confidence interval 1.05 to 1.35). This increased mortality risk with level was most pronounced in patients with lower predialysis serum potassium (K) levels (HR 2.53 [P = 0.01] for K <4.3 mEq/L versus HR 0.86 [P = 0.35] for K >4.6 mEq/L). In conclusion, digoxin use among patients who are on hemodialysis associates with increased mortality, especially among those with low predialysis K concentrations.

Background and Objectives: Randomized, controlled trials (RCTs) are the gold standard for defining causal inferences but are sometimes not feasible because of cost, ethical, or time considerations. We explored the accuracy and potential use of a "simulated trial" through the modeling of a previously published RCT, Die Deutsche Diabetes Dialyse Studie (4D Study), a landmark study that investigated the cardiovascular benefit of atorvastatin use in 1255 patients with ESRD., Design, Setting, Participants, & Measurements: Using a large historical database of interventions and outcomes in dialysis patients, we conducted an observational model of the 4D Study in dialysis patients who had type 2 diabetes and were prescribed a statin (5144 patients) and matched to a non-statin user (5144 control subjects) before multivariate modeling. Inclusion, exclusion, and outcome parameters of the study, as prespecified by the 4D Study, were strictly modeled in this analysis., Results: In covariate- and propensity-adjusted Cox regression, statin use (versus nonuse) was associated with a decrease in the composite primary outcome of cardiac death, nonfatal myocardial infarction, and stroke. Statin use was also associated with a decrease in cardiovascular mortality and all cardiac events combined. The hazard ratios in this observational model were numerically comparable to the hazard ratios reported in the 4D Study; however, because of the larger number of patients "enrolled," results in this simulated study achieved statistical significance., Conclusions: Statin use was associated with some cardiovascular benefit in a simulated trial of patients with ESRD; however, the size of benefit was considerably smaller than that seen in the general population. Such simulated trials may represent an exploratory, cost-effective option when RCTs are not immediately feasible.

Background: Incremental achievement of quality indicator goals has been associated with progressive improvement in mortality and hospitalization risk in hemodialysis (HD) patients., Study Design: Descriptive cross-sectional study., Setting & Participants: All 33,879 HD patients treated at Fresenius Medical Care North America facilities for >90 days with scorable 36-Item Short Form Health Survey responses from January 1, 2006, to December 31, 2006., Predictor: We hypothesized that achieving up to 5 HD goals before the survey (albumin >or= 4.0 g/dL, hemoglobin of 11-12 g/dL, equilibrated Kt/V >or= 1.2, phosphorus of 3.5-5.5 mg/L, and absence of HD catheter) results in better self-reported quality of life (QoL)., Outcomes & Measurements: Distributions of Physical and Mental Component Summary (PCS/MCS) scores within and across quality indicator categories determined during the prior 90 days from survey date (compared using analysis of covariance and linear regression models, with adjustment for case-mix and each of the quality indicators)., Results: Incremental achievement of up to 5 goals was associated with progressively higher PCS and MCS scores (both P for trend < 0.001). Compared with patients meeting all 5 goals (n = 4,208; reference group), case-mix-adjusted PCS score was lower by 1.8 point with only 4 goals met (n = 11,785), 3.4 points for 3 goals (n = 10,906), 4.9 points for 2 goals (n = 5,119), 5.9 points for 1 goal (n = 1,592), and 7.8 points in the 269 patients who failed to meet any goal (each P < 0.001 vs the reference group). The corresponding decreases in case-mix-adjusted MCS scores were 1.0 point for 4 goals met, 1.7 point for 3 goals, 2.3 points for 2 goals, 3.0 points for 1 goal, and 4.7 points with no goal met, with each P < 0.001 compared with the MCS score from patients who achieved all 5 goals., Limitations: Potential residual confounding from unmeasured covariates., Conclusion: Patients progressively meeting more quality goals report incrementally better QoL. Further studies are needed to determine whether prospective achievement of quality goals will result in improved QoL for HD patients.

Background: We hypothesized that a change from central venous catheters to a fistula or graft would improve short-term mortality risk in maintenance hemodialysis patients., Design: Prospective observational study., Setting & Participants: All maintenance in-center hemodialysis patients treated in Fresenius Medical Care, North America legacy facilities alive on January 1, 2007 with baseline laboratory data from December 2006., Predictor: Access type (fistula, catheter, or graft), determined on December 31, 2006, and monthly thereafter. Conversion from a catheter to a fistula or graft during the 4-month period from January 1 to April 30, 2007., Outcome: Mortality was tracked from May 1, 2007, to December 31, 2007. Standard and time-dependent Cox models were used to determine hazard risks (HRs) of death with and without adjustment for case-mix and laboratory values., Results: At baseline, 79,545 patients had 43% fistulas, 29% catheters, and 27% grafts. Mean age was 62 +/- 15 years, 54% were men, 51% were white, and 53% had diabetes. Compared with fistulas, unadjusted HRs of death were higher for grafts (1.22) and catheters (1.76; P < 0.001). In adjusted models, overall risk for grafts was decreased to 1.05 (95% limits, 1.003-1.100; P < 0.05) and approached that for fistulas consistently across multiple strata. Compared with patients who continued using a catheter, those who converted to either a graft or fistula had an HR of 0.69, whereas those who converted from a graft or fistula to a catheter had increased HRs to 2.12 (both P < 0.001). Similar trends were observed in the subset of incident patients (vintage < 90 days at study onset)., Limitations: Observational design with residual confounding from unmeasured patient, facility, and treatment-related factors., Conclusions: Catheters have the worst associated mortality risk. Changing from a catheter to a fistula or graft is associated with significantly improved survival. The risk for grafts approached that of fistulas, providing an alternative to prolonged catheter exposure and potentially less hazardous "bridge" toward a fistula.

Objective: We examined the protein anabolic effects of Pro-Stat 64, a high nitrogen-containing, enzyme-hydrolyzed, tryptophan-fortified, collagen protein supplement administrated during hemodialysis, at two different dosing regimens., Design: This was a randomized, controlled, prospective study with 3 different groups: control, single dose of supplementation, and double dose of supplementation., Setting: This study was performed at a clinical research center., Patients: Six prevalent chronic hemodialysis (HD) patients were enrolled: 5 males, 1 female, 4 African Americans, and 2 Caucasians. Their mean age was 45 +/- 11 years (S.D.). Two patients were diabetic., Methods: Protein turnover studies were performed using amino-acid (AA) balance and primed constant infusion of L-(1-(13)C) leucine., Main Outcome Measure: Whole-body protein balance was determined according to substrate kinetics., Results: There were no statistically significant difference at any time point between protocols for blood chemistries and hormonal markers, except for minor variations in plasma glucose. All plasma AA groups displayed decreases during a control study, in which no supplementation was given. Compared with the control group, plasma nonessential AA and total AA concentrations were statistically significantly higher during HD after both single and double doses of supplementation. The forearm arteriovenous AA balance was statistically significantly better for essential, nonessential, and total AA uptake after both single-dose and double-dose supplementation compared with the control group, except for nonessential AA, which was significantly better only after a double dose. Whole-body protein breakdown and net protein balance were statistically significantly better during HD with a double-dose administration in a dose-dependent manner, compared with the control and single-dose groups., Conclusions: Oral AA supplementation alone improves whole-body and skeletal muscle protein anabolism in a dose-dependent manner in chronic HD patients. These data should be taken into account during clinical decision-making or when designing clinical trials of nutritional supplementation.

Background: We evaluated whether incremental achievement of up to 8 facility quality goals was associated with improvement in facility-specific mortality and hospitalization rates., Study Design: Prospective observational study., Setting & Participants: 1,085 Fresenius Medical Care, North America facilities providing hemodialysis (HD) for 25 or more patients during January 2006., Measurements: The facility average for the period up to December 31, 2006, was used to determine achievement of each goal for equilibrated Kt/V, missed HD treatments, hemoglobin level, bicarbonate level, albumin level, phosphorus level, fistulae, and HD catheters. Linear regression models were used to relate facility-wide achievement of goals with facility-specific hospital days and standardized mortality ratios., Results: Most facilities (64%) achieved 2 to 4 of 8 goals, with only 8% meeting more than 5 quality goals. Achieving more than 5 goals averaged 3.5 fewer hospital days/patient-year and 20% lower standardized mortality ratios (all P < 0.001). The incremental number of goals met also was associated with improvement in facility mortality (P < 0.001) and hospital days (P < 0.001). Catheter and albumin level goals were achieved least (6% and 9% of facilities, respectively), but they had the best outcomes. Facilities achieving more than 5 goals had older patients (64.0 versus 61.5 years; P < 0.001), fewer African American patients (16% versus 38%; P < 0.001), and fewer women (44% versus 46%; P = 0.003) compared with the average., Limitations: Observational design with residual confounding from unmeasured patient-, facility-, and treatment-related factors., Conclusions: Achieving more facility quality goals was significantly associated with better facility-based measurements of patient outcomes. Although these results do not establish a causal relationship, findings agree with the present practice of monitoring facility performance for continuous quality improvement.

Background: Inflammation in an ESRD patient may impact responsiveness to erythropoiesis-stimulating agent (ESA) therapy. We sought to investigate the association between C-reactive protein (CRP) levels and average per-administration epoetin alfa (EPO) dose over 3 months following a CRP measurement., Methods: The study is a retrospective cohort study of hemodialysis patients >or=18 years of age receiving care at a Fresenius Medical Care-North America facility between 1 July 2000 and 30 June 2002 who had no history of peritoneal dialysis. All patients had >or=1 CRP measurement and >or=3 months of recorded information before the CRP measurement (entry period). We evaluated the association between CRP levels and average hemoglobin (Hb) and per-administration EPO dose over the 3 months following the CRP measurement., Results: We identified 1754 patients with a CRP measurement; mean age was 62.6 years (SD 14.1), 51.5% were male, 56.2% were white and the median CRP value was 2.04 mg/dL (20.4 mg/L). Patients in the upper CRP quartiles were more likely to be older, recently hospitalized; have a catheter vascular access; have lower albumin, Hb and transferrin saturation levels and greater EPO doses. In the subsequent 3 months, EPO doses but not Hb levels were significantly higher for patients in the highest CRP quartile [3.21 mg/dL (32.1 mg/L)] (P = 0.01)., Conclusions: Inflammation as measured by an elevated CRP level appears to be an independent predictor of greater ESA dose requirements. Patients with the highest CRP levels required significantly higher ESA doses to achieve comparable Hb levels even after controlling for potential confounding variables.

Background: To determine the most significant potentially actionable clinical variables associated with mortality and hospitalization risk in hemodialysis (HD) patients., Study Design: Cohort study., Setting & Participants: Adult maintenance HD patients in the Fresenius Medical Care, North America database as of January 1, 2004, with baseline information from October 1, 2003, to December 31, 2003, comprising approximately 26% of the US HD population., Predictors: Case-mix (age, sex, race, diabetes, vintage, and body surface area), vascular access, and laboratory (albumin, equilibrated Kt/V, hemoglobin, calcium, phosphorus, creatinine, bicarbonate, biointact parathyroid hormone, transferrin saturation, and white blood cell count) variables., Outcomes: 1-year mortality and hospitalization risk from January 1 to December 31, 2004., Measurements: Cox proportional hazards models for death and hospitalization., Results: The cohort (N = 78,420) had a mean age of 61.4 +/- 15.0 years, 47% were women, 49% were white, 41% were black race (10% defined as "other"), and 52% had diabetes. The top 5 actionable variables were the same for mortality and hospitalization. Final case-mix plus laboratory-adjusted hazard ratios for these top 5 actionable variables indicate 177% increased risk of death and 67% increased risk of hospitalization per 1-g/dL decrease in albumin level, 39% and 45% greater risk with catheters compared with fistulas, 18% and 9% greater risk per 1-mg/dL greater phosphorus level, 11% and 9% lower risk per 1-g/dL greater hemoglobin level, and 5% and 2% greater risk per 0.1-unit decrease in equilibrated Kt/V, respectively (all P < 0.0001)., Limitations: Observational cross-sectional study with limited comorbidity adjustment (for diabetes)., Conclusion: The same variables are associated with both mortality and hospitalization in HD patients. The top 5 potentially actionable variables are readily identifiable, with albumin level and catheter use the most prominent, and all 5 are appropriate targets for improvement.

Background: Medicare data indicate that black hemodialysis patients receive greater doses of erythropoietin (EPO) than white patients when achieving similar hemoglobin levels. We confirmed and evaluated this observed association between race and EPO dose., Study Design: Cross-sectional cohort study., Setting & Participants: Primary Medicare-insured white (57%) and black (43%) adult long-term hemodialysis patients treated by Fresenius Medical Care who received EPO from January 1 to 31, 2004 (N = 44,721)., Predictor: White/black race., Outcomes: Average weekly EPO dose., Measurements: Associations between race and baseline demographic and laboratory variables were evaluated by using logistic and linear regression models. Correlates of log-transformed weekly EPO dose were determined using linear regression models., Results: Black patients received 12.6% more EPO than white patients (95% limits, 10.9% to 14.3%; P < 0.001). This racial difference in EPO dose was observed across similar hemoglobin levels despite fewer catheters (P < 0.001) and fewer prior hospitalization events in black patients (P = 0.002). Black patients were younger and had larger body size and greater albumin and biointact parathyroid hormone levels, but lower equilibrated Kt/V and white blood cell counts (all P < 0.001). In the 95th percentile of EPO dose (those receiving > 60,000 U/wk), there was a greater proportion of black patients (6% of total black population compared with only 4% in all white patients; P < 0.001). The difference in EPO dose between black and white patients was modified by age and was significant at ages younger than 45 and 65 years or older., Limitations: Observational study limited to white and black adult Medicare patients only, correlating with EPO doses from a single month, without adjustment for comorbid conditions., Conclusions: Black patients were administered approximately 12% greater EPO doses than white patients while achieving similar hemoglobin levels. We identified variables that differed across race that may explain this difference, but they were either not actionable or presented limited opportunity for intervention. Additional studies are needed to define a physiological (or pathological) basis for these observations.

Objective: Our objective was to estimate the effect of an improvement in nutrition, represented by albumin concentrations, on hospitalization, mortality, and Medicare end-stage renal disease (ESRD) program cost., Design: Based on published trials, the impact of an improvement in serum albumin of +0.2 g/dL from a hypothetical nutritional program for severely malnourished patients with albumin < or = 3.5 g/dL (base case) was estimated by reassigning patients to higher albumin categories, along with outcome risks associated with the new albumin category., Setting: Data from Fresenius Medical Care North America (Waltham, MA) were utilized in regression models to determine the association between albumin and change in albumin concentration with outcomes., Results: Albumin < or = 3.5 g/dL was associated with a > 2-fold increase in death and hospitalization risk, compared to > or = 4 g/dL (P < .001) in this population. An increase in albumin concentration was associated with a lower risk of death and hospitalization, whereas a declining albumin concentration led to worse outcomes. Projections for the United States dialysis population from the base case showed approximately 1400 lives saved, approximately 6000 hospitalizations averted, and approximately $36 million in Medicare cost savings resulting from a reduction of approximately 20,000 hospital days. A sensitivity analysis, varying the albumin response to +0.1 and +0.3 g/dL combined with varying albumin responder rates to 25% and 75% of patients, revealed robust results., Conclusion: Nutritional interventions that increase serum albumin by > or = 0.2 g/dL (e.g., via oral nutritional supplements) may lead to considerable improvements in mortality, hospitalization, and treatment costs.

The success of Fistula First nationwide has been accompanied by an unplanned increase in hemodialysis catheters. Complications related to prolonged hemodialysis catheter use include increased morbidity, mortality, and cost. We hypothesize that the national focus on increasing fistulas may have inadvertently diverted attention away from initiatives to decrease dependence on hemodialysis catheters. Based on a synthesis of guidelines, reviews, published evidence, and the authors' opinions, we propose that the national vascular access initiative be revised to have a dual goal of Fistula First and "Catheters Last." These goals are not mutually exclusive, but rather complementary. We recommend a systematic refocus on interventions that not only increase fistulas, but help avoid extended catheter use. Clearly, the ideal practice for hemodialysis vascular access remains early placement of fistulas with enough maturation time such that they can be used for initiating long-term hemodialysis therapy when the need arises. To effect this change, a reimbursement policy covering the costs associated with permanent access placement before the need for dialysis is essential. Individualized patient management strategies may consider such innovative approaches as initiating patients on peritoneal dialysis therapy or using nonautogenous grafts as bridge accesses in lieu of catheters. For patients who are dialyzing using catheters, immediate active planning for permanent access placement and removal of the catheter is necessary. In the same vein as Fistula First, the renal community should once again be galvanized in working together toward controlling the catheter epidemic in our dialysis population.

Dialysis providers are capable and interested in participating in the care of CKD patients. But dialysis providers do not, for the most part, become involved in the patients' care until CMS Form 2728 is completed and signed by the attending nephrologist. We believe that dialysis providers are interested in broadening their role, but only if the nephrology community believes this role is appropriate and supports such a resource collaboration. If CMS wants dialysis providers to get more involved in CKD patient management, it is extremely important that this effort not be another unfunded mandate that will result in an increase in the burden on current nursing, dietary, and social work dialysis staff providing current ESRD care. If dialysis providers are to collaborate on CKD care with the nephrology community, they must staff appropriately and there must be a definitive change in the Medicare reimbursement system to support the use of CKD guidelines that will result in a healthier and less costly patient presenting to the dialysis program at the point that they reach end-stage renal disease.

Background: Knowledge of urea volume of distribution (Vurea) in patients with acute renal failure (ARF) is critical in order to prescribe and monitor appropriate dialytic treatment. We have recently shown that in ARF patients, Vurea estimation by urea kinetic modeling is significantly higher than total body water (TBW) by anthropometric estimation. However, these estimates of Vurea and TBW have not been validated by isotopic methods, considered as reference measurement standards., Methods: In this study, we measured Vurea by [13C]urea and TBW by deuterium oxide (D2O) in 21 patients with ARF (14 males, 7 females, age 62.0 +/- 10.6 years old, 83% Caucasian, 17% African American) at three different centers. These measurements were compared to TBW estimates from anthropometric and bioelectrical impedance (BIA) measurements., Results: Our results show that Vurea by [13C]urea (51.0 +/- 11.7 L) is significantly higher than TBW estimated by all other methods (TBW by D2O: 38.3 +/- 9.8 L, P < 0.001; TBW by BIA: 45.7 +/- 15.7 L, P= 0.08; TBW by Watson formula: 38.3 +/- 7.3 L, P < 0.001; TBW by Chertow formula: 39.3 +/- 7.8 L, P= 0.002, all versus Vurea). Despite significant overestimation of the absolute value and considerable variation, Vurea significantly correlated with TBW by BIA (r= 0.66, P < 0.01) and TBW by D2O (r= 0.5, P= 0.04). There was also significant correlation between D2O and BIA determined TBW (r= 0.8, P < 0.001)., Conclusion: In terms of useful guidelines to prescribe a specific dose of dialysis in patients with ARF, conventional estimates of TBW as surrogates for Vurea should be used with caution. We propose that these conventional estimates of TBW should be increased by approximately 20% (a factor of 1.2) to avoid significant underdialysis.

Objective: End-stage renal disease (ESRD) patients with signs of uremic malnutrition at the time of initiation of maintenance hemodialysis (MHD) are likely to remain malnourished over the subsequent year. Because poor nutritional status is associated with worse clinical outcomes in MHD patients, we hypothesized that ESRD patients with evidence of uremic malnutrition at the time of initiation of MHD would have more hospitalization events compared with patients initiating MHD without signs of malnutrition during the first year of therapy., Design/intervention: This was an observational cohort of incident MHD patients, with no specific nutritional intervention., Setting: Vanderbilt University Outpatient Dialysis Unit., Patients: All newly initiated MHD patients at Vanderbilt University Outpatient Dialysis Unit were recruited for study purposes. A total of 149 patients were included in the study., Main Outcome Measure: The following parameters were recorded at the time of initiation of MHD: age; race; gender; serum concentrations of albumin, creatinine, cholesterol, and transferrin; and whether the patient had insulin-dependent diabetes mellitus. The number of hospital admissions and length of stay in the hospital were recorded for all study patients during the first year of MHD. Associated hospital charges were obtained for a subgroup of 52 patients., Results: Study variables were associated with hospitalization in the subsequent year, the number of hospital admissions, and the length of stay in the hospital. Patients who initiated MHD in the lowest quartile of serum albumin had a significantly greater average of admissions compared with patients who initiated in the highest quartile (1.77 +/- 1.82 versus 0.72 +/- 0.96 admissions, P =.002). The length of stay in the hospital was also higher in the lowest quartile of serum albumin (8.96 +/- 9.96 versus 3.83 +/- 5.68 days, P =.006). Serum creatinine was also inversely associated with greater average number of admissions (2.27 +/- 2.41 versus 0.83 +/- 1.68 admissions, P =.004) and longer length of stay (12.43 +/- 15.15 versus 4.72 +/- 11.57 days, P =.017) in lowest compared with the highest quartile. In addition, the costs associated with hospitalizations were higher in the group of patients initiating MHD with lower concentrations of serum albumin and serum creatinine., Conclusions: In this study of incident MHD patients, the concentrations of 2 nutritional parameters, serum albumin and serum creatinine at the time of initiation of MHD, were significantly and negatively associated with hospitalization events. There was also a trend for greater hospital charges in patients with lower concentrations of serum albumin and creatinine.

Background: Protein-calorie malnutrition is a significant problem for patients with end-stage renal disease. Increased resting energy expenditure may be an important contributing factor. We postulate that resting energy expen diture in the different stages of renal disease and treatments may be different., Methods: Resting energy expenditure was measured using a whole-room indirect calorimeter (metabolic chamber) along with nutritional parameters and body composition after 12-hour fasting in 15 patients with advanced chronic renal failure patients, 15 patients on chronic hemodialysis, and 10 patients on peritoneal dialysis. Patients on hemodialysis were assessed on a non-dialysis day. A 2-day dietary recall was used to assess energy intake., Results: Resting energy expenditure, adjusted for fat-free mass, was similar in patients on hemodialysis and peritoneal dialysis but significantly higher than in patients with chronic renal failure (p < .05). Resting energy expenditure in all patients were generally higher (10% to 20%) than predicted values using standard equations derived in normal and obese populations, whereas daily energy intake was less (26% to 34%) than energy expenditure for all groups, adjusted for light daily activity., Conclusions: End-stage renal disease patients displayed increases in resting energy expenditure over the predicted values derived using normal populations. Resting energy expenditure was significantly higher in patients receiving dialysis, regardless of the modality, than patients with chronic renal failure. Daily energy intake was substantially less than required in all patient groups studied, suggesting that patients with renal failure could develop protein-calorie malnutrition because of increased resting energy expenditure, which is exacerbated by dialysis.

Uremic malnutrition and chronic inflammation are important comorbid conditions that predict poor clinical outcome in end-stage renal disease (ESRD) patients. These conditions are also closely associated with cardiovascular disease, the major cause of death in ESRD patients. A pathophysiologic link between malnutrition, inflammation, and atherosclerosis has been proposed in this patient population. Indeed, multiple lines of evidence suggest that chronic inflammation can predispose ESRD patients to a catabolic and atherogenic state. Malnutrition can also result from chronic inflammation and can accelerate the progression of cardiovascular disease. Whereas a single common etiology has not been identified in this complex process, nutritional and anti-inflammatory interventions provide potential treatment options to counter the high mortality and morbidity in ESRD patients.