In-center Maintenance Hemodialysis Research Articles

Adapting a pain coping skills training intervention for people with chronic pain receiving maintenance hemodialysis for end stage Kidney disease.

Pain Coping Skills Training (PCST) is a first-line cognitive-behavioral, non-pharmacological treatment for chronic pain and comorbid symptoms. PCST has been shown to be effective in racially and ethnically diverse cohorts across several chronic medical conditions. However, PCST has not been evaluated in those with end stage kidney disease (ESKD) receiving in-center maintenance hemodialysis. Due to the high rates of morbidity associated with ESKD, and time-intensive treatment, an adaptation of PCST was warranted to address the unique challenges experienced by people living with ESKD. Using current guidelines developed by Card and colleagues for intervention adaptation, PCST was adapted so that it could be implemented among people living with ESKD in a national multisite trial. The objective of this paper was to describe the adaption process outlined by Card and colleagues including how the team selected an effective intervention to adapt, developed a program model, identified mismatches in the original intervention and study population, and then adapted the intervention for those with ESKD treated with in-center maintenance hemodialysis. Finally, we briefly describe future directions for clinical practice and research with the adapted PCST intervention for those with ESKD.Trial registration: ClinicalTrials.gov #NCT04571619.

The Ottawa Statement implementation guidance document for cluster randomized trials in the hemodialysis setting

Research teams are increasingly interested in using cluster randomized trial (CRT) designs to generate practice-guiding evidence for in-center maintenance hemodialysis. However, CRTs raise complex ethical issues. The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials, published in 2012, provides 15 recommendations to address ethical issues arising within 7 domains: justifying the CRT design, research ethics committee review, identifying research participants, obtaining informed consent, gatekeepers, assessing benefits and harms, and protecting vulnerable participants. But applying the Ottawa Statement recommendations to CRTs in the hemodialysis setting is complicated by the unique features of the setting and population. Here, with the help of content experts and patient partners, we co-developed this implementation guidance document to provide research teams, research ethics committees, and other stakeholders with detailed guidance on how to apply the Ottawa Statement recommendations to CRTs in the hemodialysis setting, the result of a 4-year research project. Thus, our work demonstrates how the voices of patients, caregivers, and all stakeholders may be included in the development of research ethics guidance.

#4319 ASSOCIATION BETWEEN INTRADIALYTIC HYPERTENSION FREQUENCY AND SHORT-TERM CLINICAL OUTCOMES AMONG ESRD PATIENTS RECEIVING HEMODIALYSIS

Abstract Background and Aims Systolic blood pressure (SBP) pattern in hemodialysis (HD) is typically characterized by a rapid decrease during the start of HD and followed by a more gradual decline in the latter part of the treatment. Deviation from the typical BP trend with a paradoxical rise in BP during HD, has been associated with increased mortality and morbidity and therefore, could be a modifiable risk marker for short-term adverse events in this population. Physicians may usually pay more attention to the more common complication that is hypotension during dialysis than the pattern of BP rise, hence overlooking a significant marker for poor prognosis. This study aims to investigate the association of intradialytic hypertension with short-term 30-day clinical outcomes including hospitalizations and mortality. Previous observational studies have suggested that changes in blood pressure during dialysis is associated with mortality and morbidity, however, the exact mechanism is still unclear. Method This study is a prospective cohort study of ESRD patients receiving in-center maintenance hemodialysis in a tertiary hospital in Davao City. All patients who were more than 18 years old and at least 1-year hemodialysis vintage were included. The study collected data from patients within a 30-day observation period and recorded the occurrence of events within the next 30-day follow-up period. Data collection was done from July 2022 to August 2022. Results In this study, patients had an average age of 49.18 years, majority of 55.56% were male and the most common cause of ESRD was glomerular disease. This study demonstrates that the incidence of intradialytic hypertension in this institution is high at 49.38%. Among the 81 enrolled patients, 16% had short term outcomes. Among the patients, 13.5% were hospitalized within the follow-up period and majority of 63.6% of them had IDH. All of the 2.47% of patients who expired during the follow-up period had IDH. Patients who had concomitant heart failure (p-value <0.001), has non-tunneled catheter as vascular access (p-value 0.004), high intradialytic frequency of 50–87.5% (p-value <0.001), and interdialytic weight gain of at least 2 kilograms (p-value 0.029) were significantly associated with hospitalization and mortality within 30 days. Conclusion The results of this study recommends that prompt attention should be given to ESRD patients who exhibit IDH as this may be a risk marker for adverse short term events within 30 days. In line with this, setting of dry weight, screening for heart failure, conversion to permanent AVF access, and tailoring of anti-hypertensive medications for better BP control should be assessed with vigilance in the dialysis unit.

Hypertension in Patients Treated With In-Center Maintenance Hemodialysis: Current Evidence and Future Opportunities: A Scientific Statement From the American Heart Association.

Nearly 500 000 individuals are treated with maintenance hemodialysis for kidney failure in the United States, and roughly half will die of cardiovascular causes. Hypertension, an important and modifiable risk factor for cardiovascular disease, is observed in >80% of patients treated with maintenance hemodialysis. The pathophysiology of hypertension in patients treated with maintenance hemodialysis is multifactorial and differs from that seen in other patient populations. Factors that contribute to hypertension in patients treated with hemodialysis include volume overload, arterial stiffness, enhanced activity of the sympathetic nervous and renin-angiotensin-aldosterone systems, endothelial dysfunction, and use of erythropoietin-stimulating agents. This scientific statement reviews the current evidence on defining, diagnosing, and treating hypertension in patients treated with maintenance hemodialysis and highlights opportunities for future investigation, including studies on blood pressure targets and treatment strategies.

Infection Control Practices in In-Center Hemodialysis Units During Wave 1 of the COVID-19 Pandemic in Ontario, Canada: Research Letter.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a virus that caused coronavirus disease 2019 (COVID-19), the multisystem disease central to the COVID-19 pandemic. As patients receiving in-center maintenance hemodialysis require treatment 3 times weekly, they were unable to fully isolate. It was important for in-center hemodialysis units to implement robust infection control practices to ensure patient safety and minimize risk of transmitting SARS-CoV-2 among patients and staff. There are 27 renal programs within Ontario, Canada, providing care for about 9000 people across about 100 in-center hemodialysis units. These units are funded by the Ontario Renal Network (ORN), which is part of the provincial agency Ontario Health. The objective was to track infection control practices that were implemented by in-center hemodialysis units and be able to provide a descriptive narrative of the COVID-19 pandemic response of Ontario's hemodialysis units between March and September 2020. Between May and September 2020, data were collected from Ontario's 27 renal programs on the implementation of key infection control practices, including symptom screening, use of personal protective equipment, testing, practices specifically related to patients from congregate living settings, other prevention practices, and outbreak management. There were 4 data collection cycles, each approximately 1 month apart. The results were compiled and shared across the province, and infection control practices were also discussed at provincial COVID-19 teleconferences hosted by the ORN. By March 2020, all but one renal program had implemented one or more forms of symptom screening, all renal programs had implemented physical distancing in waiting rooms and restricted visitors, and 74% of renal programs had implemented universal masking for all staff. By April 2020, 89% of renal programs had implemented universal masking for all patients, 52% had implemented enhanced contact and droplet precautions for suspected or positive cases, and 59% of renal programs tested all patients from congregate living settings regularly (with a low symptom threshold for testing). Infection control practices became more homogeneous across renal programs over time, and most practices were in place as of the last data collection. The renal system in Ontario was able to respond quickly within the first 2 months of the pandemic to minimize the spread of COVID-19 within in-center hemodialysis units. Through provincial teleconferences, infection control practices were shared across the province as the pandemic and hemodialysis unit responses evolved. This supported renal programs to advocate locally if their hospital was lagging in practices felt to be of value in other hemodialysis units. Although no direct correlation can be made regarding the implementation of infection control practices within in-center hemodialysis units and the number of COVID-19 cases in this population, the limited number of outbreaks in hemodialysis units may have been influenced by the proactive response of renal programs. Practices described in this article may support management and response to subsequent waves of COVID-19 or future similar infectious diseases.

The Feasibility of a Transitional Care Unit for Patients Newly Started on In-Center Hemodialysis: A Research Letter.

Patients with end-stage kidney disease face high mortality and morbidity after dialysis initiation. Transitional care units (TCUs) are typically 4- to 8-week structured multidisciplinary programs targeted toward patients starting hemodialysis during this high-risk time in their care. The goals of such programs are to provide psychosocial support, provide dialysis modality education, and reduce risks of complications. Despite apparent benefits, the TCU model may be challenging to implement, and the effect on patient outcomes is unclear. To assess a newly created multidisciplinary TCUs' feasibility for patients newly started on hemodialysis. Before-and-after study. Kingston Health Sciences Centre hemodialysis unit in Ontario, Canada. We considered all adult patients (age 18+) who initiated in-center maintenance hemodialysis eligible for the TCU program, although patients on infection control precautions and evening shifts were not able to receive TCU care due to staffing limitations. We defined feasibility as eligible patients completing the TCU program in a timely fashion without additional need for space, no signal of harm, and without explicit concerns from TCU staff or patients at weekly meetings. Key outcomes at 6 months included mortality, proportion hospitalized, dialysis modality, vascular access, initiation of transplant workup, and code status. The TCU care consisted of 1:1 nursing and education until predefined clinical stability and dialysis decisions were satisfied. We compared outcomes among the pre-TCU cohort who initiated hemodialysis between June 2017 and May 2018, and TCU patients who initiated dialysis between June 2018 and March 2019. We summarized outcomes descriptively, along with unadjusted odds ratios (ORs) and 95% confidence intervals (CIs). We included 115 pre-TCU patients and 109 post-TCU patients, of whom 49/109 (45%) entered and completed the TCU. The most common reasons for not participating in the TCU included evening hemodialysis shifts (18/60, 30%) or contact precautions (18/60, 30%). The TCU patients completed the program in a median of 35 (25-47) days. We observed no differences in mortality (9% vs 8%; OR = 0.93, 95% CI = 0.28-3.13) or proportion hospitalized (38% vs 39%; OR = 1.02, 95% CI = 0.51-2.03) between the pre-TCU cohort and TCU patients. There was also no difference in use of home dialysis (16% vs 10%; OR = 1.67, 95% CI = 0.64-4.39), non-catheter access (32% vs 25%; OR = 1.44, 95% CI = 0.69-2.98), initiation of transplant workup (14% vs 12%; OR 1.67; 95% CI = 0.64-4.39), and choosing "do not resuscitate" (DNR) orders (22% vs 19%; OR = 1.22, 95% CI = 0.54-2.77). There was no negative patient or staff feedback on the program. Small sample size and potential for selection bias given inability to provide TCU care for patients on infection control precautions or evening shifts. The TCU accommodated a large number of patients, who completed the program in a timely fashion. The TCU model was determined to be feasible at our center. There was no difference in outcomes due to the small sample size. Future work at our center is required to expand the number of TCU dialysis chairs to evening shifts and evaluate the TCU model in prospective, controlled studies.

Overall Adverse Event Profile of Vadadustat versus Darbepoetin Alfa for the Treatment of Anemia Associated with Chronic Kidney Disease in Phase 3 Trials

Introduction: Anemia frequently occurs in chronic kidney disease (CKD), is associated with poor quality of life and cardiovascular outcomes, and its treatment represents a considerable economic burden to the healthcare system. Although effective, the current standard of care for the treatment of anemia in chronic kidney disease patients with erythropoiesis-stimulating agents requires chronic/ongoing injections, making the treatment less accessible or desirable to patients not treated by in-center maintenance hemodialysis. Furthermore, safety concerns, including an increased risk of cardiovascular events and mortality, have emerged from their use in studies targeting hemoglobin concentrations in the normal or near-normal range. The orally active hypoxia-inducible factor prolyl hydroxylase inhibitor vadadustat may offer advantages over erythropoiesis-stimulating agents by correcting anemia via pathways activating endogenous erythropoietin production. Methods: To comprehensively analyze the safety profile of vadadustat in patients with dialysis-dependent and non-dialysis-dependent CKD-related anemia, we pooled the safety populations from each of the four trials in the phase 3 clinical program (n = 7,373) and compared the risk of treatment-emergent adverse events (TEAEs) for each treatment arm. Results: In patients randomized to vadadustat versus darbepoetin alfa, rates of TEAEs (88.9% vs. 89.3%), treatment-emergent serious adverse events (58.0% vs. 59.3%), and TEAEs leading to death (16.1% vs. 16.2%) were similar, as were rates of adverse events of special interest, including cardiovascular-, hepatic-, and neoplasm-related adverse events. Discussion/Conclusion: Among patients with CKD-related anemia treated with vadadustat, we observed similar rates of adverse events relative to those treated with darbepoetin alfa.

Dynamics of spreading of SARS-CoV-2 in a Belgian hemodialysis facility: The importance of the analysis of viral strains.

In‐center maintenance hemodialysis (HD) patients are at high risk of acquiring coronavirus disease 2019 (COVID‐19) by cross‐contamination inside the unit. The aim of this study was to assess retrospectively the dynamics of severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) transmission during the very first pandemic phase (March–July 2020) in a cohort of in‐center maintenance HD patients and in nurses the same HD facility, using a phylogenetic approach. All SARS‐CoV‐2 quantitative reverse‐transcription polymerase chain reaction positive patients and nurses from our HD unit‐respectively 10 out of 98, and 8 out of 58‐ and two other positive patients dialyzed in our self‐care unit were included. Whole‐genome viral sequencing and phylogenetic analysis supported the cluster investigation. Five positive patients were usually dialyzed in the same room and same shift before their COVID‐19 diagnosis was made. Viral sequencing performed on 4/5 patients' swabs showed no phylogenetic link between their viruses. The fifth patient (whose virus could not be sequenced) was dialyzed at the end of the dialysis room and was treated by a different nurse than the one in charge of the other patients. Three nurses shared the same virus detected in both self‐care patients (one of them had been transferred to our in‐center facility). The epidemiologically strongly suspected intra‐unit cluster could be ruled out by viral genome sequencing. The infection control policy did not allow inter‐patient contamination within the HD facility, in contrast to evidence of moderate dissemination within the nursing staff and in the satellite unit. Epidemiologic data without phylogenetic confirmation might mislead the interpretation of the dynamics of viral spreading within congregate settings.

Analysis of Respiratory Fluoroquinolones and the Risk of Sudden Cardiac Death Among Patients Receiving Hemodialysis

Respiratory fluoroquinolone antibiotics are some of the most common medications with QT interval-prolonging potential prescribed to patients with hemodialysis-dependent kidney failure-individuals who have a very high risk of sudden cardiac death (SCD). To date, there have been no large-scale, population-specific studies evaluating the cardiac safety of respiratory fluoroquinolones in the hemodialysis population. To investigate the cardiac safety of respiratory fluoroquinolones among individuals with hemodialysis-dependent kidney failure. A retrospective cohort study examining safety using an active comparator new-user design was conducted using administrative claims data from a US-wide kidney failure registry from January 1, 2007, to December 31, 2016, including 264 968 Medicare beneficiaries receiving in-center maintenance hemodialysis. Data analysis was performed from January 4 to August 16, 2021. Respiratory fluoroquinolone (levofloxacin or moxifloxacin) vs amoxicillin-based (amoxicillin or amoxicillin with clavulanic acid) antibiotic treatment. Sudden cardiac death within 5 days of outpatient initiation of a study antibiotic. Inverse probability of treatment-weighted survival models to estimate hazard ratios (HRs), risk differences (RDs), and corresponding 95% CIs. Death due to a cause other than SCD was treated as a competing event. Fracture was considered as a negative control outcome. The study cohort included 264 968 unique in-center hemodialysis patients and 626 322 study antibiotic treatment episodes: 251 726 respiratory fluoroquinolone treatment episodes (40.2%) and 374 596 amoxicillin-based treatment episodes (59.8%). Of the 264 968 patients, 135 236 (51.0%) were men, and the mean (SD) age was 61 (15) years. Respiratory fluoroquinolone vs amoxicillin-based antibiotic treatment was associated with a higher relative and absolute 5-day risk of SCD (weighted HR, 1.95; 95% CI, 1.57-2.41; and weighted RD per 100 000 treatment episodes, 44.0; 95% CI, 31.0-59.2). Respiratory fluoroquinolone vs amoxicillin-based antibiotic treatment was not associated with the 5-day risk of fracture. In this study, compared with amoxicillin-based antibiotic treatment, respiratory fluoroquinolone treatment was associated with a higher short-term risk of SCD among patients with hemodialysis-dependent kidney failure. This finding suggests that decisions between the use of respiratory fluoroquinolones and amoxicillin-based antibiotics should be individualized, with prescribers considering both the clinical benefits and potential cardiac risks.

Improving Primary Care Delivery for Patients Receiving Maintenance Hemodialysis

The beneficial impact of primary care, focused on all aspects of a patient's health (rather than a disease-specific focus) is well established. Recognized benefits include greater receipt of preventive care and counseling, lower use of emergency care and hospitalization for ambulatory care-sensitive conditions, and decreased early mortality. Although the importance of primary care and care coordination at the primary care/specialty interface is well recognized, the role of primary care within traditional and emerging care models for patients receiving in-center maintenance hemodialysis remains ill-defined. In this perspective article, we will describe: (1) the role of primary care for patients receiving maintenance hemodialysis and the current evidence regarding the receipt of primary care among these patients; (2) the key challenges to delivery of primary care in these complex cases, including suboptimal care coordination between nephrology and primary care providers, the intensity of dialysis care, and the limited capacity of nephrologists and primary care providers to meet the broad health needs of hemodialysis patients; (3) potential strategies for improving the delivery of primary care for patients receiving hemodialysis; and (4) future research requirements to improve primary care delivery for this high-risk population.

SARS-CoV-2 Seropositivity Rates in Patients and Clinical Staff in New York City Dialysis Facilities: Association With the General Population

There are concerns that in-center maintenance hemodialysis (HD) patients may have higher risk for infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) because they take 3 or more round-trips a week to dialysis centers and spend several hours during dialysis close to fellow patients and clinic staff. This concern is supported by data from dialysis facilities in London, United Kingdom.1

A Cost-Effective Analysis of the CYCLE-HD Randomized Controlled Trial

IntroductionNo formal cost-effectiveness analysis has been performed for programs of cycling exercise during dialysis (intradialytic cycling [IDC]). The objective of this analysis is to determine the effect of a 6-month program of IDC on health care costs.MethodsThis is a retrospective formal cost-effectiveness analysis of adult participants with end-stage kidney disease undertaking in-center maintenance hemodialysis enrolled in the CYCLE-HD trial. Data on hospital utilization, primary care consultations, and prescribed medications were extracted from medical records for the 6 months before, during, and after a 6-month program of thrice-weekly IDC. The cost-effectiveness analysis was conducted from a health care service perspective and included the cost of implementing the IDC intervention. The base-case analyses included a 6-month “within trial” analysis and a 12-month “within and posttrial” analysis considering health care utilization and quality of life (QoL) outcomes.ResultsData from the base-case within trial analysis, based on 109 participants (n = 56 control subjects and n = 53 IDC subjects) showed a reduction in health care utilization costs between groups, favoring the IDC group, and a 73% chance of IDC being cost-effective compared with control subjects at a willingness to pay of £20,000 and £30,000 per quality-adjusted life year (QALY) gained. When QoL data points were extrapolated forward to 12 months, the probability of IDC being cost-effective was 93% and 94% at £20,000 and £30,000 per QALY gained. Sensitivity analysis broadly confirms these findings.ConclusionA 6-month program of IDC is cost-effective and the implementation of these programs nationally should be a priority.

Patient reactions to witnessed medical events in the dialysis center or to the sudden absence of other patients from the center: A qualitative study.

Patients receiving in-center maintenance hemodialysis (HD) spend a significant amount of time together. To date, little or no research has examined how these patients perceive and process other patients' medical events in and absences from their centers. We therefore undertook this qualitative study using semi-structured interviews to explore these phenomena from the patient perspective. Patients at a suburban Pittsburgh HD center participated in semi-structured interviews in April to May 2011, reporting on their impressions of their relationships with other patients in the center; their experiences of witnessing clinical decompensations in the center; and their reactions to absences of fellow patients from the center. Trained coders developed a codebook and applied it to interview transcripts. There were 17 participants, 47% women, 29% black, with median age 63 years. Almost every participant had witnessed other patients' medical events during HD. Three main themes emerged in analysis of interviews: (1) incomplete knowledge of many aspects of witnessed events and patient absences in the HD center; (2) a process of "filling in the blanks": Participants used their own past events and absences to help process other patients' events and absences and used other patients' events and absences to help process their own future events and absences; and (3) participants' broad support for HD center staff being able to share with other patients basic information about their whereabouts if they themselves are absent from the center. Witnessed medical events in and patients' absences from the HD center are not only common but are also important to patients, who struggle to process these events and absences due to limited information about what actually happened. Interventions, such as providing patients with more information, could improve patients' experience of witnessed events and fellow patients' absences and potentially impact other patient-centered outcomes.

Dialysis, COVID-19, Poverty, and Race in Greater Chicago: An Ecological Analysis

Rationale & ObjectivePersons with end-stage kidney disease receiving in-center maintenance hemodialysis may be at high risk for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) exposure and severe outcomes with coronavirus disease 2019 (COVID-19). The objective of this study was to examine the correlation of SARS-CoV-2 positivity rate per capita and COVID-19–associated deaths with number of dialysis stations and demographics of residents within zip codes in Cook County, IL.Study DesignEcological analysis.Setting & ParticipantsData for SARS-CoV-2 test results and COVID-19–associated deaths during January 21 to June 15, 2020, among the 5,232,412 residents living within the 163 zip codes in Cook County, IL, were merged with demographic and income data from the US Census Bureau. The total number of positive test results in this population was 84,353 and total number of deaths was 4,007.AssessmentsNumber of dialysis stations and stations per capita within a zip code were calculated. SARS-CoV-2–positive test results per capita were calculated as number of positive test results divided by the zip code population. COVID-19–associated deaths per capita were calculated as COVID-19 deaths among residents for a given zip code divided by the zip code population.Analytic ApproachSpearman rank correlation coefficients were calculated to examine the correlation of SARS-CoV-2–positive tests per capita and COVID-19–associated deaths per capita with dialysis stations, demographics, and household poverty. To account for multiple testing, statistical significance was considered as P < 0.005.ResultsAmong the 163 Cook County zip codes, there were 2,501 dialysis stations. Positive test results per capita were significantly associated with number of dialysis stations (r = 0.25; 95% CI, 0.19 to 0.29; P < 0.005) but not with dialysis stations per capita (r = 0.02; 95% CI, −0.03 to 0.08; P = 0.7). Positive test results per capita also correlated significantly with number of households living in poverty (r = 0.57; 95% CI, 0.53-0.6; P < 0.005) and percentage of residents reporting Black race (r = 0.28; 95% CI, 0.23-0.33; P < 0.005) and Hispanic ethnicity (r = 0.68; 95% CI, 0.65-0.7; P < 0.001;). COVID-19–associated deaths per capita correlated significantly with the percentage of residents reporting Black race (r = 0.24; 95% CI, 0.19-0.29; P < 0.005) and with percentage of households living in poverty (r = 0.34; 95% CI, 0.29-0.38; P < 0.005). The association between the number of COVID-19–associated deaths per capita and total number of dialysis stations (r = 0.20; 95% CI, 0.14-0.25; P = 0.01) did not achieve a priori significance, whereas the association with dialysis stations per capita (r = 0.12; 95% CI, 0.07-0.17; P = 0.01) was not significant.LimitationsAnalysis is at the zip code level and not at the person level.ConclusionsThe number of dialysis stations within a zip code correlates with the SARS-CoV-2 positivity rate per capita in Cook County, IL, and this correlation may be driven by population density and the demographics of the residents. These findings highlight the high risk of SARS-CoV-2 exposure for patients with end-stage kidney disease living in poor urban areas.

Comparative Effectiveness of High-Dose Versus Standard-Dose Influenza Vaccine Among Patients Receiving Maintenance Hemodialysis

Studies of patients on maintenance dialysis therapy suggest that standard-dose influenza vaccine (SDV) may not prevent influenza-related outcomes. Little is known about the comparative effectiveness of SDV versus high-dose influenza vaccine (HDV) in this population. Cohort study using data from the US Renal Data System. 507,552 adults undergoing in-center maintenance hemodialysis between the 2010 to 2011 and 2014 to 2015 influenza seasons. SDV and HDV. All-cause mortality, hospitalization due to influenza or pneumonia, and influenza-like illness during the influenza season. Patients were eligible for inclusion in multiple yearly cohorts; thus, our unit of analysis was the influenza patient-season. To examine the relationship between vaccine dose and effectiveness outcomes, we estimated risk differences and risk ratios using propensity score weighting of Kaplan-Meier functions, accounting for a wide range of patient- and facility-level characteristics. For nonmortality outcomes, we used competing-risk methods to account for the high mortality rate in the dialysis population. Within 225,215 influenza patient-seasons among adults 65 years and older, 97.4% received SDV and 2.6% received HDV. We observed similar risk estimates for HDV and SDV recipients for mortality (risk difference,-0.08%; 95% CI,-0.85% to 0.80%), hospitalization due to influenza or pneumonia (risk difference, 0.15%; 95% CI,-0.69% to 0.93%), and influenza-like illness (risk difference, 0.00%; 95% CI,-1.50% to 1.08%). Our findings were similar among adults younger than 65 years, as well as within other subgroups defined by influenza season, age group, dialysis vintage, month of influenza vaccination, and vaccine valence. Residual confounding and outcome misclassification. The HDV does not appear to provide additional protection beyond the SDV against all-cause mortality or influenza-related outcomes for adults undergoing hemodialysis. The additional cost and side effects associated with HDV should be considered when offering this vaccine. Future studies of HDV and other influenza vaccine strategies are warranted.

Oral nutritional supplements and 30-day readmission rate in hypoalbuminemic maintenance hemodialysis patients.

Hemodialysis (HD) patients are hospitalized nearly twice yearly, and 35% of these patients are rehospitalized within 30-days postdischarge. We hypothesized that monitored oral nutritional supplementation (ONS) during HD treatment may decrease readmissions. A cohort of maintenance HD patients, treated at a large dialysis organization, who were hospitalized with a postdischarge albumin of ≤3.5 g/dL, without documented ONS use 90 days prior to the index hospitalization were identified. Individuals who received monitored intradialytic ONS postdischarge were compared to those without receipt of ONS. The outcome of interest was 30-day hospital readmissions. Logistic regression was used to assess the association between ONS receipt and 30-day readmission events, with adjustment for case-mix and laboratory variables. Of 5479 eligible patients, ONS was prescribed to 1420 individuals. Mean age was 64.6 ± 14.1 (SD) years; median dialysis vintage was 3.9 years. There were 274 (19%) readmissions among ONS recipients vs. 1571 (38.7%) among controls during the 30-day follow-up period. Individuals who did not receive ONS had increased odds of readmission [OR 2.26 (95% CI 1.02, 2.53)] in 30 days, as compared to those who did receive ONS postdischarge. In sensitivity analyses using a propensity score matched cohort, the odds ratio of readmissions within 30 days postdischarge was 1.71 (95% CI: 1.42, 2.07) for individuals who did not receive ONS as compared to those who received ONS. Consumption of ONS during HD sessions is associated with reduced hospital readmission rates among in-center maintenance HD with severe hypoalbuminemia at 30 days post-hospital discharge.

Fostering Innovation in Symptom Management among Hemodialysis Patients: Paths Forward for Insomnia, Muscle Cramps, and Fatigue.

Individuals receiving in-center maintenance hemodialysis bear a high burden of both physical and mood symptoms. More than half of patients on hemodialysis report sleep disturbance, muscle cramps, and fatigue. Patients describe symptoms as having a deleterious effect on their quality of life, suggesting that symptom alleviation may meaningfully improve patient-reported outcomes. Moreover, patients on hemodialysis have identified symptom management as a key area for research and innovation, prioritizing symptom alleviation over other health outcomes such as mortality and biochemical indices. Despite the importance of symptoms to patients, there has been little research explicitly geared toward improving patient symptoms, and therefore minimal innovation in symptom management. In general, the physiologic underpinnings of symptoms are poorly understood, hampering the development of targeted therapies. In fact, there have been few drugs or devices approved by the US Food and Drug Administration for the indication of improving any patient-reported outcomes for patients on hemodialysis. Recognizing this gap in innovation, the Kidney Health Initiative, a public-private partnership between the American Society of Nephrology and US Food and Drug Administration, convened a workgroup to first prioritize symptoms for the development of therapeutic interventions, and then identify near-term actionable research goals for the prioritized physical symptoms of insomnia, muscle cramps, and fatigue. This paper summarizes the pathophysiology of the three prioritized symptoms, identifies key knowledge gaps, acknowledges factors that challenge development of new therapies, and offers the nephrology community actionable research goals for insomnia, muscle cramps, and fatigue.

Glycemic Control and Infections among U.S. Hemodialysis Patients with Diabetes Mellitus

Patients with diabetes mellitus (DM) and those who are on hemodialysis (HD) may be particularly vulnerable to infections, but there is a dearth of clinical data on the relationship between glycemic control and infections in patients with DM on HD. We used data from the U.S. Renal Data System and the electronic health records from a large U.S. dialysis provider (DaVita, Inc.) merged at the patient level. We included adult Medicare-insured patients with DM aged ≥18 years who initiated in-center maintenance HD treatment from 20to 2011 and survived &amp;gt;90 days. The exposure was time-averaged HbA1c and quarterly mean HbA1c values were categorized as follows: &amp;lt;5.5%, 5.5-&amp;lt;6.5% (reference), 6.5-&amp;lt;7.5%, 7.5-&amp;lt;8.5%, and ≥8.5%. We used Medicare claims to ascertain infection-related hospitalizations and the ESRD Death Notification (CMS-2746) to identify death from infections. The primary outcome was the composite of infection-related death or hospitalization with all-cause death and transplant treated as competing risks using the Kaplan-Meier multiple imputation (MI) method. Missing data were handled through MI. We used extended-Cox models to estimate multivariable-adjusted hazard ratios (HR) and 95% CI for the associations between time-averaged HbA1c and the outcome, adjusting for baseline demographics and quarterly updated comorbidities from claims, central venous catheter use, and time-averaged vital signs and laboratory results. Among 33,753 eligible patients, 9415 infection-related hospitalizations occurred and 6deaths were linked to infection. Compared with patients with HbA1c 5.5-&amp;lt;6.5%, the adjusted HRs for infection-related death or hospitalization were 1.03 (CI, 0.96, 1.10), 1.03 (CI, 0.97, 1.09), 1.02 (0.95, 1.09), and 1.02 (CI, 0.95, 1.09) for patients with HbA1c &amp;lt;5.5%, 6.5-&amp;lt;7.5%, 7.5-&amp;lt;8.5%, and ≥8.5%, respectively (P-trend=0.97). In summary, time-averaged HbA1c was not associated with the risk of a composite outcome of infection-related mortality or hospitalization. Disclosure J.J. Rhee: None. Y. Zheng: None. M. Montez-Rath: None. W. Winkelmayer: Advisory Panel; Self; Akebia Therapeutics, Amgen Inc., Bayer AG, FibroGen, Inc., AMAG Pharmaceuticals, Vifor Fresenius Medical Care Renal Phama, Relypsa Inc..

Oral Intradialytic Nutritional Supplement Use and Mortality in Hemodialysis Patients

Hemodialysis patients have high mortality rates, potentially reflecting underlying comorbid conditions and ongoing catabolism. Intradialytic oral nutritional supplements may reduce this risk. Retrospective propensity-matched cohort. Maintenance hemodialysis patients treated at Dialysis Clinic Inc facilities who were initiated on a nutritional supplement protocol in September to October 2010 were matched using a propensity score to patients at facilities at which the protocol was not used. Prescription of the protocol, whereby hemodialysis patients with serum albumin levels ≤3.5g/dL would initiate oral protein supplementation during the dialysis procedure. Sensitivity analyses matched on actual supplement intake during the first 3 study months. Covariates included patient and facility characteristics, which were used to develop the propensity scores and adjust multivariable models. All-cause mortality, ascertained though March 2012. Of 6,453 eligible patients in 101 eligible hemodialysis facilities, the protocol was prescribed to 2,700, and 1,278 of these were propensity matched to controls. Mean age was 61 ± 15 (SD) years and median dialysis vintage was 34 months. There were 258 deaths among protocol assignees versus 310 among matched controls during a mean follow-up of 14 months. In matched analyses, protocol prescription was associated with a 29% reduction in the hazard of all-cause mortality (HR, 0.71; 95% CI, 0.58-0.86); adjustment had minimal impact on models. In time-dependent models incorporating change in albumin level, protocol status remained significant but was attenuated in models incorporating a 30-day lag. Similar results were seen in sensitivity analyses of 439 patients receiving supplements who were propensity-matched to controls, with 116 deaths among supplement users versus 140 among controls (HR, 0.79; 95% CI, 0.60-1.05), achieving statistical significance in adjusted models. Observational design, potential residual confounding. Prescription of an oral nutritional supplement protocol and use of oral protein nutritional supplements during hemodialysis are associated with reduced mortality among in-center maintenance hemodialysis patients, an effect likely not mediated by change in serum albumin levels.

Effect of a Dietitian-managed Bone Algorithm on Serum Phosphorus Level in Maintenance Hemodialysis Patients

This study examined the effectiveness of a registered dietitian (RD)-managed bone metabolism algorithm compared with a non-RD (registered nurse and the nephrologist)-managed one on serum phosphorus (PO4) and related clinical outcomes (corrected serum calcium [cCa] level, intact parathyroid hormone [iPTH] level, incidence of parathyroidectomy) among in-center maintenance hemodialysis (MHD) patients. The study was an 18-month retrospective review of adult MHD patients (n = 252) at 5 outpatient dialysis centers in western Massachusetts and Connecticut before and after change in the management of a comprehensive bone metabolism treatment algorithm (intravenous vitamin D, phosphate-binding medication, calcimimetic) from non-RD to RD. Calendar-matched timepoints representing 3-month averages during the non-RD- and RD-managed periods of the same algorithm were used for analyses. Comparisons of outcomes at non-RD-managed timepoint 2 (February 2009-April 2009) and RD-managed timepoint 6 (February 2010-April 2010) were performed considering potential demographic and clinical confounders. On average, serum PO4 level was lower during the RD-managed timepoint 6 (5.17 ± 1.23 mg/dL; mean ± standard deviation) compared with non-RD-managed timepoint 2 (5.23 ± 1.24 mg/dL), although the difference between these calendar-matched timepoints was not statistically significant (F = .108, P = .74) after controlling for age, dietary intake (equilibrated normalized protein catabolic rate), and dialysis adequacy (equilibrated Kdrt/V). Mean cCa at RD-managed timepoint 6 (8.76 ± 0.65 mg/dL) was not significantly different from non-RD-managed timepoint 2 (8.79 ± 0.74), and the difference between serum iPTH level at timepoint 6 (363.0 ± 296.8 pg/mL) compared with timepoint 2 (319.8 ± 251.5 pg/mL) was nonsignificant (F = .650, P = .42) after controlling for age. There were fewer parathyroidectomies during the RD-managed period (0.8%) compared with the non-RD-managed period (1.6%). RDs may be equally effective as non-RDs in bone metabolism algorithm management with respect to serum PO4, cCa, and iPTH control in MHD patients. Further research is needed to prospectively evaluate the effect of RD management on these bone mineral outcomes.