Patient-Centered Outcomes With a Multidisciplinary CKD Care Team Approach: An Observational Study.

Rationale & Objective: Multidisciplinary chronic kidney disease (CKD) care has been associated with improved clinical outcomes in comparison to general nephrology care. However, there is little research examining the impact of multidisciplinary care on patient-centered outcomes. We examined if a multidisciplinary approach to CKD care was associated with 4 patient-centered outcomes. Study Design: Cross-sectional study design using previously established surveys to assess patient-centered outcomes in participants with nondialysis CKD. Setting & Participants: Adults with CKD stages 1-5 who had not undergone transplant or were not on dialysis. Exposures: General nephrology care or multidisciplinary care. Patients receiving multidisciplinary care were seen by a pharmacist, social worker, dietitian, and nephrologist, whereas patients receiving general nephrology care only saw a nephrologist. Outcomes: Four patient-centered outcomes: CKD-specific knowledge, disease-related stress, perception of overall health, and perception of health status compared to 1 year ago. Analytical Approach: Differences were examined using a Welch 2-sample t test and linear regression model. Results: Mean age of participants was 60 years with standard deviation of 17 years. 182 (77%) patients were White, and 230 (96%) had formal education greater than or equal to high school. 121 (49%) were women, and 215 (88%) had CKD stage 3-5. 77 (31%) received multidisciplinary care. We did not identify any significant differences in patient knowledge, stress, or perception of health between multidisciplinary and general nephrology care. However, notably, patients in multidisciplinary care were older and had more advanced CKD than those in general nephrology care. Limitations: Cross-sectional study designs only identify associations. Study was conducted at clinics located within 30 miles of each other, limiting generalizability. Conclusions: Our results suggest that a team-based approach to care can better support sicker, more vulnerable patients so that they can achieve similar patient-centered outcomes compared to patients who are younger and with less advanced CKD.

The Impact of COVID-19 on Postdischarge Outcomes for Dialysis Patients in the United States: Evidence from Medicare Claims Data.

Background: Recent investigations have shown that, on average, patients hospitalized with coronavirus disease 2019 (COVID-19) have a poorer postdischarge prognosis than those hospitalized without COVID-19, but this effect remains unclear among patients with end-stage kidney disease (ESKD) who are on dialysis. Methods: Leveraging a national ESKD patient claims database administered by the US Centers for Medicare and Medicaid Services, we conducted a retrospective cohort study that characterized the effects of in-hospital COVID-19 on all-cause unplanned readmission and death within 30 days of discharge for patients on dialysis. Included in this study were 436,745 live acute-care hospital discharges of 222,154 Medicare beneficiaries on dialysis from 7871 Medicare-certified dialysis facilities between January 1 and October 31, 2020. Adjusting for patient demographics, clinical characteristics, and prevalent comorbidities, we fit facility-stratified Cox cause-specific hazard models with two interval-specific (1-7 and 8-30 days after hospital discharge) effects of in-hospital COVID-19 and effects of prehospitalization COVID-19. Results: The hazard ratios due to in-hospital COVID-19 over the first 7 days after discharge were 95% CI, 1.53 to 1.65 for readmission and 95% CI, 1.38 to 1.70 for death, both with P<0.001. For the remaining 23 days, the hazard ratios were 95% CI, 0.89 to 0.96 and 95% CI, 0.86 to 1.07, with P<0.001 and P=0.50, respectively. Effects of prehospitalization COVID-19 were mostly nonsignificant. Conclusions: In-hospital COVID-19 had an adverse effect on both postdischarge readmission and death over the first week. With the surviving patients having COVID-19 substantially selected from those hospitalized, in-hospital COVID-19 was associated with lower rates of readmission and death starting from the second week.

Association of the Comprehensive ESRD Care Model with Treatment Adherence.

Background: Poor adherence to scheduled dialysis treatments is common and can cause adverse clinical and economic outcomes. In 2015, the Centers for Medicare and Medicaid Innovation launched the Comprehensive ESRD Care (CEC) Model, a novel modification of the Accountable Care Organization framework. Many model participants reported efforts to increase dialysis adherence and promptly reschedule missed treatments. Methods: With Medicare databases covering 2014-2019, we used difference-in-differences models to compare treatment adherence among patients aligned to 1037 CEC facilities relative to those aligned to matched comparison facilities, while accounting for their differences at baseline. Using dates of service, we identified patients who typically received three weekly treatments and the days when treatments typically occurred. Skipped treatments were defined as days when the patient was not hospitalized but did not receive an expected treatment, and rescheduled treatments as days when a patient who had skipped their previous treatment received an additional treatment before their next expected treatment date. Results: Patients in the CEC Model had higher odds of attending as-scheduled sessions relative to the comparison group, although the effect was only marginally significant (OR, 1.02; 95% CI, 1.00 to 1.04, P=0.08). Effects were stronger among females (OR, 1.03; 95% CI, 1.00 to 1.06, P=0.06) than males (OR, 1.01; 95% CI, 0.98 to 1.04, P=0.49), and among those aged <70 years (OR, 1.02; 95% CI, 1.00 to 1.05, P=0.04) than those aged ≥70 years (OR, 1.00; 95% CI, 0.96 to 1.04, P=0.96). The CEC was associated with higher odds of rescheduled sessions (OR, 1.09; 95% CI, 1.05 to 1.14, P<0.001). Effects were significant for both sexes, but were larger among males (OR, 1.11; 95% CI, 1.05 to 1.18, P<0.001) than females (OR, 1.07; 95% CI, 1.02 to 1.13, P=0.01), and effects were significant among those <70 years (OR, 1.12; 95% CI, 1.07 to 1.17, P<0.001), but not those ≥70 years (OR, 0.99; 95% CI, 0.92 to 1.07, P=0.80). Conclusions: The CEC Model is intended to incentivize strategies to prevent costly interventions. Because poor dialysis adherence may precipitate hospitalizations or other adverse events, many CEC Model participants encouraged adherence and promptly rescheduled missed treatments as strategic priorities. This study suggests these efforts were a success, although the absolute magnitudes of the effects were modest.

COVID-19 Risk Factors and Mortality Outcomes Among Medicare Patients Receiving Long-term Dialysis.

Importance: There is a need for studies to evaluate the risk factors for COVID-19 and mortality among the entire Medicare long-term dialysis population using Medicare claims data. Objective: To identify risk factors associated with COVID-19 and mortality in Medicare patients undergoing long-term dialysis. Design, Setting, and Participants: This retrospective, claims-based cohort study compared mortality trends of patients receiving long-term dialysis in 2020 with previous years (2013-2019) and fit Cox regression models to identify risk factors for contracting COVID-19 and postdiagnosis mortality. The cohort included the national population of Medicare patients receiving long-term dialysis in 2020, derived from clinical and administrative databases. COVID-19 was identified through Medicare claims sources. Data were analyzed on May 17, 2021. Main Outcomes and Measures: The 2 main outcomes were COVID-19 and all-cause mortality. Associations of claims-based risk factors with COVID-19 and mortality were investigated prediagnosis and postdiagnosis. Results: Among a total of 498 169 Medicare patients undergoing dialysis (median [IQR] age, 66 [56-74] years; 215 935 [43.1%] women and 283 227 [56.9%] men), 60 090 (12.1%) had COVID-19, among whom 15 612 patients (26.0%) died. COVID-19 rates were significantly higher among Black (21 787 of 165 830 patients [13.1%]) and Hispanic (13 530 of 86 871 patients [15.6%]) patients compared with non-Black patients (38 303 of 332 339 [11.5%]), as well as patients with short (ie, 1-89 days; 7738 of 55 184 patients [14.0%]) and extended (ie, ≥90 days; 10 737 of 30 196 patients [35.6%]) nursing home stays in the prior year. Adjusting for all other risk factors, residing in a nursing home 1 to 89 days in the prior year was associated with a higher hazard for COVID-19 (hazard ratio [HR] vs 0 days, 1.60; 95% CI 1.56-1.65) and for postdiagnosis mortality (HR, 1.31; 95% CI, 1.25-1.37), as was residing in a nursing home for an extended stay (COVID-19: HR, 4.48; 95% CI, 4.37-4.59; mortality: HR, 1.12; 95% CI, 1.07-1.16). Black race (HR vs non-Black: HR, 1.25; 95% CI, 1.23-1.28) and Hispanic ethnicity (HR vs non-Hispanic: HR, 1.68; 95% CI, 1.64-1.72) were associated with significantly higher hazards of COVID-19. Although home dialysis was associated with lower COVID-19 rates (HR, 0.77; 95% CI, 0.75-0.80), it was associated with higher mortality (HR, 1.18; 95% CI, 1.11-1.25). Conclusions and Relevance: These results shed light on COVID-19 risk factors and outcomes among Medicare patients receiving long-term chronic dialysis and could inform policy decisions to mitigate the significant extra burden of COVID-19 and death in this population.

Telavancin pharmacokinetics in patients with chronic kidney disease receiving haemodialysis.

BACKGROUND: Telavancin is a lipoglycopeptide antibiotic with limited pharmacokinetic data to guide drug dosing in patients receiving haemodialysis. OBJECTIVES: This study characterized telavancin pharmacokinetics in patients receiving haemodialysis. PATIENTS AND METHODS: This was a Phase IV, prospective, open-label, single-centre, crossover pharmacokinetic study (ClinicalTrials.gov: NCT02392208). Eight subjects with end-stage kidney disease requiring maintenance haemodialysis (mean ±â€ŠSD: 47 ±â€Š20 years, 69.5 ±â€Š17.1 kg) received 5 mg/kg telavancin IV 3 h before starting a 3.5 hour haemodialysis treatment with a high-permeability haemodialyser (haemodialysis period). After a 14 day washout period, a second 5 mg/kg dose was administered post-haemodialysis (control period). Telavancin plasma concentrations were measured over a 2 day period after each dose and non-compartmental pharmacokinetic analyses were performed. RESULTS: The geometric mean (GM) of telavancin overall clearance was 11.2 mL/h/kg (intrinsic clearance and dialytic clearance) in the haemodialysis period and 5.9 mL/h/kg (off-haemodialysis clearance) in the control period [GM ratio (GMR) = 1.89; 90% CI: 1.70-2.10; P < 0.01]. The GM t½ was 13.1 h when haemodialysis occurred 3 h post-dosing in the haemodialysis period but extended to 20.9 h with post-haemodialysis dosing in the control period (GMR = 0.63; 90% CI: 0.54-0.73; P < 0.01). The GM of telavancin plasma concentrations removed by haemodialysis was 27.7%. The GMR of peak plasma concentration and volume of distribution of the haemodialysis period and the control period were 0.88 (90% CI: 0.79-0.98; P = 0.08) and 1.17 (90% CI: 1.05-1.30; P = 0.048), respectively. CONCLUSIONS: Haemodialysis with high-permeability haemodialysers removes telavancin considerably (∼⅓ of body load). Telavancin 5 mg/kg every 48 h post-haemodialysis dosing is recommended, but dose adjustments may be warranted if haemodialysis starts within 3 h of telavancin administration.

Acute Kidney Injury Requiring Dialysis and Incident Dialysis Patient Outcomes in US Outpatient Dialysis Facilities.

BACKGROUND AND OBJECTIVES: About 30% of patients with AKI may require ongoing dialysis in the outpatient setting after hospital discharge. A 2017 Centers for Medicare & Medicaid Services policy change allows Medicare beneficiaries with AKI requiring dialysis to receive outpatient treatment in dialysis facilities. Outcomes for these patients have not been reported. We compare patient characteristics and mortality among patients with AKI requiring dialysis and patients without AKI requiring incident dialysis. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: We used a retrospective cohort design with 2017 Medicare claims to follow outpatients with AKI requiring dialysis and patients without AKI requiring incident dialysis up to 365 days. Outcomes are unadjusted and adjusted mortality using Kaplan-Meier estimation for unadjusted survival probability, Poisson regression for monthly mortality, and Cox proportional hazards modeling for adjusted mortality. RESULTS: In total, 10,821 of 401,973 (3%) Medicare patients requiring dialysis had at least one AKI claim, and 52,626 patients were Medicare patients without AKI requiring incident dialysis. Patients with AKI requiring dialysis were more likely to be White (76% versus 70%), non-Hispanic (92% versus 87%), and age 60 or older (82% versus 72%) compared with patients without AKI requiring incident dialysis. Unadjusted mortality was markedly higher for patients with AKI requiring dialysis compared with patients without AKI requiring incident dialysis. Adjusted mortality differences between both cohorts persisted through month 4 of the follow-up period (all P=0.01), then, they declined and were no longer statistically significant. Adjusted monthly mortality stratified by Black and other race between patients with AKI requiring dialysis and patients without AKI requiring incident dialysis was lower throughout month 4 (1.5 versus 0.60, 1.20 versus 0.84, 1.00 versus 0.80, and 0.95 versus 0.74; all P<0.001), which persisted through month 7. Overall adjusted mortality risk was 22% higher for patients with AKI requiring dialysis (1.22; 95% confidence interval, 1.17 to 1.27). CONCLUSIONS: In fully adjusted analyses, patients with AKI requiring dialysis had higher early mortality compared with patients without AKI requiring incident dialysis, but these differences declined after several months. Differences were also observed by age, race, and ethnicity within both patient cohorts.

Arteriovenous Fistula Use in the United States and Dialysis Facility-Level Comorbidity Burden.

RATIONALE & OBJECTIVE: Patients with multiple comorbid conditions are less likely to use an arteriovenous fistula (AVF) for hemodialysis vascular access. Some dialysis facilities have high rates of AVF placement despite having patients with many comorbid conditions. This study describes variation in facility-level use of AVFs across the facility-level burden of patient comorbid conditions. STUDY DESIGN: Retrospective cohort study. SETTING & PARTICIPANTS: Medicare patients receiving hemodialysis for 1 year or more in US dialysis facilities. PREDICTORS: Facility-level burden of patient comorbid conditions; patient characteristics. OUTCOMES: Odds of AVFs versus other access types; facility-level use of AVFs. ANALYTICAL APPROACH: Facility-level comorbidity burden was calculated by summing individual comorbid conditions, determining the average per patient, then defining 11 groups based on facility percentile ranking. Generalized estimating equations with a logit link were used to estimate the odds of AVF placement at the patient level. For the facility-level analysis, a generalized estimating equation model with the identity link was fit to characterize the percentage of AVF use at each facility. RESULTS: Overall, AVF use was 65.8% in 315,919 prevalent hemodialysis patients among 5,813 facilities. After adjustment for patient characteristics, AVF use was 0.27, 0.30, 1.05, and 1.74 percentage points lower than the median among facilities in the 61st to 70th, 71st to 80th, 81st to 90th, and 91st to 99th percentiles of comorbidity, respectively, and 0.42, 0.63, 1.34, and 1.90 percentage points higher than the median among facilities in the 31st to 40th, 21st to 30th, 11th to 20th, and 1st to 10th percentiles of comorbidity, respectively. Facilities in the greater than 99th percentile of comorbidity burden had AVF use that was 3.47 percentage points lower than the median. Facilities in the less than 1st percentile of comorbidity burden had AVF use that was 2.64 percentage points greater than the median. LIMITATIONS: Limited to Medicare dialysis-dependent patients treated for 1 year or more. CONCLUSIONS: After adjustment for patient characteristics, we found small differences in facility rates of AVF use except in the extremes of high or low levels of comorbidity burden. Our study demonstrates that dialysis facilities with a relatively high patient comorbidity burden can achieve similar fistula rates as facilities with healthier patients. Although high comorbidity burden does not explain low facility AVF use, additional study is needed to understand differences in AVF use rates between facilities with similar comorbidity burdens.

Single dose oral ranolazine pharmacokinetics in patients receiving maintenance hemodialysis.

PURPOSE: Ranolazine is a novel anti-angina treatment approved in the United States for chronic stable angina. Ranolazine pharmacokinetics have not been studied previously in patients who receive maintenance hemodialysis. This study describes the pharmacokinetics of ranolazine and three major metabolites (CVT-2738, CVT-2512, CVT-2514) in patients receiving thrice weekly hemodialysis. METHODS: Eight participants receiving maintenance hemodialysis completed this prospective, open-label study (study identifier NCT01435174 at Clinicaltrials.gov). Three participants received a single tablet of ranolazine 500 mg (followed by an interim analysis), and five received 2 tablets of ranolazine 500 mg. Blood samples were collected over 65 h to determine the pharmacokinetic characteristics during and between hemodialysis sessions. Non-compartmental analysis was used to determine the individual pharmacokinetic parameters. RESULTS: Ranolazine off-hemodialysis elimination phase half-lives were 3.6 and 3.9 h for 500 mg and 1000 mg doses, respectively. The time to maximum concentration ranged from 2 to 18 hours and the average maximum concentration was 0.65 ± 0.27 mcg/mL and 1.18 ± 0.48 mcg/mL for ranolazine 500 mg and 1000 mg dose, respectively. The mean hemodialysis percent reduction ratio for the ranolazine 500 mg dose was 52.3 ± 8.1% and for the ranolazine 1000 mg dose was 69.2 ± 37.6%. CONCLUSIONS: Data on ranolazine dosing in patients receiving maintenance hemodialysis is almost non-existent. Given the extent of pharmacokinetic variability observed with the 500 mg and 1000 mg oral doses of ranolazine, neither can be recommended as a starting dose in patients receiving maintenance hemodialysis. Guided by the information gained form this study about the extent of hemodialytic drug clearance, further multi-dose clinical trials of ranolazine are needed to optimize therapeutic outcomes in this patient population.

Continuous quality improvement in nephrology: a systematic review.

BACKGROUND: Continuous quality improvement (CQI) has been successfully applied in business and engineering for over 60 years. While using CQI techniques within nephrology has received increased attention, little is known about where, and with what measure of success, CQI can be attributed to improving outcomes within nephrology care. This is particularly important as payors' focus on value-based healthcare and reimbursement is tied to achieving quality improvement thresholds. We conducted a systematic review of CQI applications in nephrology. METHODS: Studies were identified from PubMed, MEDLINE, Scopus, Web of Science, CINAHL, Google Scholar, ProQuest Dissertation Abstracts and sources of grey literature (i.e., available in print/electronic format but not controlled by commercial publishers) between January 1, 2004 and October 13, 2014. We developed a systematic evaluation protocol and pre-defined criteria for review. All citations were reviewed by two reviewers with disagreements resolved by consensus. RESULTS: We initially identified 468 publications; 40 were excluded as duplicates or not available/not in English. An additional 352 did not meet criteria for full review due to: 1. Not meeting criteria for inclusion = 196 (e.g., reviews, news articles, editorials) 2. Not nephrology-specific = 153, 3. Only available as abstracts = 3. Of 76 publications meeting criteria for full review, the majority [45 (61%)] focused on ESRD care. 74% explicitly stated use of specific CQI tools in their methods. The highest number of publications in a given year occurred in 2011 with 12 (16%) articles. 89% of studies were found in biomedical and allied health journals and most studies were performed in North America (52%). Only one was randomized and controlled although not blinded. CONCLUSIONS: Despite calls for healthcare reform and funding to inspire innovative research, we found few high quality studies either rigorously evaluating the use of CQI in nephrology or reporting best practices. More rigorous research is needed to assess the mechanisms and attributes by which CQI impacts outcomes before there is further promotion of its use for improvement and reimbursement purposes.

Reverse Epidemiology of Blood Pressure in Peritoneal Dialysis Associated with Dynamic Deterioration of Left Ventricular Function.

UNLABELLED: ♦ BACKGROUND: Reverse epidemiology of blood pressure (BP) in end-stage kidney disease (ESKD) is manifested as higher mortality at lower blood pressure. We hypothesize that this phenomenon is partially mediated by deterioration of cardiac structure and function. ♦ METHODS: Seventy-seven prevalent ESKD patients starting renal replacement therapy on peritoneal dialysis (PD) from 2007 to 2012 were evaluated for the primary outcome of all-cause mortality. Longitudinal data were obtained from 1,930 patient-encounters including monthly clinic BP and serial echocardiograms. Generalized linear mixed models using data from the last observation moving backward, and time-to-event analysis using time-varying Cox-survival models to estimate mortality risk at different blood pressure categories were applied. ♦ RESULTS: There were 39 males (50.6%). Mean age was 51 years (standard deviation [SD] = 15). During follow-up, 20 patients (25%) died. As compared to systolic blood pressure (SBP) of 140-159 mmHg, unadjusted risk of mortality was 7.3 (95% confidence interval [CI]: 1.5-35.7, p = 0.008) at level < 120 mmHg. Systolic BP trended down to an average of 117 mmHg prior to death in non-survivors as compared to 141 mmHg in survivors (p < 0.05). In non-survivors, percentage with concentric left ventricular hypertrophy (LVH) decreased by 20% at the expense of a 20% reciprocal increase in eccentric hypertrophy associated with a 30% increase in percentage with low ejection fraction (EF) (< 50%). After adjusting for EF, risk of mortality at SBP < 120 mmHg attenuated to 3.4 (95% CI: 0.7-17.7, p = 0.14). ♦ CONCLUSION: We conclude that higher mortality associated with lower BP may be mediated in part by worsening heart function in ESKD patients receiving PD.

Intradialytic hypotension: frequency, sources of variation and correlation with clinical outcome.

Intradialytic hypotension (IH) is a frequent complication of hemodialysis (HD) and is associated with increased patient mortality and cardiovascular events. We studied IH to determine its variability, correlates, and clinical impact in 13 outpatient HD facilities. Blood pressure was captured by machine download. IH was defined as >30 mmHg decrease in systolic blood pressure to <90 mmHg. Risk factors were assessed by logistic regression and hospitalization by Poisson regression. Time to death and first hospitalization were assessed using Kaplan-Meier analysis in patients completing >20 HD treatments. We studied IH in 44,801 treatments (Tx) in 1137 patients. IH was frequent (17.2% of treatments) and highly variable by patient (0-100% Tx) and dialysis facility (11.1-25.8% Tx). 25.1% of patients had no IH (0% Tx) and 16.2% had IH on >35% Tx. Increased IH frequency was associated with age, female gender, diabetes, Hispanic origin, longer end stage renal disease vintage, higher body mass index, higher ultrafiltration volume, the second and third weekly Tx, lower pre-HD systolic blood pressure, higher difference between prescribed and achieved post-HD weight, and higher dialysate temperature. Dialysis facility was an independent predictor of IH frequency. Patients with >35% IH treatments had poorer survival (P = 0.036), and more frequent and longer hospitalization (P = 0.04, P = 0.002, respectively) than patients without IH. In conclusion, IH frequency was highly variable, associated with individual facilities, patient and treatment characteristics, and correlated with mortality and hospitalization. Identifying practice patterns associated with IH coupled with routine reporting of IH will facilitate medical management and may result in the prevention of IH, decreased mortality, and decreased hospitalization.

Prevention of peritonitis in peritoneal dialysis.

Reducing the frequency of peritonitis for patients undergoing peritoneal dialysis (PD) continues to be a challenge. This review focuses on recent updates in catheter care and other patient factors that influence infection rates. An experienced nursing staff plays an important role in teaching proper PD technique to new patients, but nursing staff must be cognizant of each patient's unique educational needs. Over time, many patients become less adherent to proper dialysis technique, such as washing hands or wearing a mask. This behavior is associated with higher risk of peritonitis and is modifiable with re-training. Prophylactic antibiotics before PD catheter placement can decrease the infection risk immediately after catheter placement. In addition, some studies suggest that prophylaxis against fungal superinfection after antibiotic exposure is effective in reducing fungal peritonitis, although larger randomized studies are needed before this practice can be recommended for all patients. Over time, exit site and nasal colonization with pathogenic organisms can lead to exit-site infections and peritonitis. For patients with Staphylococcus aureus colonization, exit-site prophylaxis with either mupirocin or gentamicin cream reduces clinical infection with this organism. Although there are limited data for support, antibiotic prophylaxis before gastrointestinal, gynecologic, or dental procedures may also help reduce the risk of peritonitis.

Effects of citrate acid concentrate (citrasate®) on heparin N requirements and hemodialysis adequacy: a multicenter, prospective noninferiority trial.

BACKGROUND: Citrasate®, citric acid dialysate (CD), contains 2.4 mEq of citric acid (citrate), instead of acetic acid (acetate) as in standard bicarbonate dialysate. Previous studies suggest CD may improve dialysis adequacy and decrease heparin requirements, presumably due to nonsystemic anticoagulant effects in the dialyzer. METHODS: We prospectively evaluated 277 hemodialysis patients in eight outpatient facilities to determine if CD with reduced heparin N (HN) would maintain dialyzer clearance. Subjects progressed through four study periods [baseline (B): bicarbonate dialysate + 100% HN; period 1 (P1): CD + 100% HN; period 2 (P2): CD + 80% HN; period 3 (P3): CD + 66.7% HN]. The predefined primary endpoint was noninferiority (margin -8%) of the percent change in mean dialyzer conductivity clearance between baseline and P2. RESULTS: Subjects were 57.4% male, 41.7% white, 54.3% black, and 44.4% diabetic; mean age was 59 ± 14.4 years; mean time on dialysis was 1,498 ± 1,165 days; 65.7% had arteriovenous fistula, 19.9% arteriovenous graft, 14.4% catheters, and 27.8% used antiplatelet agents. Mean dialyzer clearance increased 0.9% (P1), 1.0% (P2), and 0.9% (P3) with CD despite heparin reduction. SpKt/V remained stable (B: 1.54 ± 0.29; P1: 1.54 ± 0.28; P2: 1.55 ± 0.27; P3: 1.54 ± 0.26). There was no significant difference in dialyzer/dialysis line thrombosis, post-HD time to hemostasis, percent of subjects with adverse events (AEs), or study-related AEs. CONCLUSIONS: CD was safe, effective, and met all study endpoints. Dialyzer clearance increased approximately 1% with CD despite 20-33% heparin reduction. Over 92% of P3 subjects demonstrated noninferiority of dialyzer clearance with CD and 33% HN reduction. There was no significant difference in dialyzer clotting, bleeding, or adverse events.

Invited manuscript poster on renal-related education American Society of Nephrology, Nov. 16-21, 2010. Adolescents with chronic kidney disease and their need for online peer mentoring: a qualitative investigation of social support and healthcare transition.

Adolescents with chronic kidney disease (CKD) tend to be isolated from peers who also have CKD, develop non-adherent behavior with treatment recommendations, and consequently are at higher risk for poor health outcomes such as transplant rejection. At the same time, patients in this age group tend to be technologically savvy and well-versed in using Internet-based communication tools to connect with other people. In this study, we conducted semi-structured interviews among adolescents with CKD to assess their information needs and their interest in using a CKD-oriented peer-mentoring website that we are developing, kTalk.org. We interviewed 17 adolescents with CKD, ages 14-18 years old, to learn about (1) any concerns regarding transition from pediatric to adult care teams; and (2) their interest in using the Internet as a source for disease-related information and as a social networking tool for finding and interacting with their peers. The interviews were digitally recorded, transcribed, and qualitatively analyzed. Results showed that (1) the adolescent participants are commonly concerned about transitioning to an adult clinic; (2) they are isolated from peers with the same medical condition who are of similar age; (3) they are frequent Facebook users and are highly interested in exploring the possibility of using an online community website, such as kTalk.org, to discover and communicate with peers and peer mentors; and (4) there exist divergent opinions regarding if an online community of adolescent CKD patients should be open to the public.

Carbamazepine and the active epoxide metabolite are effectively cleared by hemodialysis followed by continuous venovenous hemodialysis in an acute overdose.

Hemodialysis (HD) and continuous venovenous hemodialysis (CVVHD) have an unproven role in the management of carbamazepine overdose. Albumin-enhanced CVVHD may accelerate carbamazepine (CBZ) clearance, but no pharmacokinetic data has been reported for traditional CVVHD without albumin enhancement. In addition, it is unclear whether the active CBZ-epoxide metabolite is removed with either mode of dialysis. We present a case of CBZ intoxication successfully managed with sequential HD and CVVHD. The CBZ half-life during CVVHD was 14.7 hours, compared with the patient's endogenous half-life of 30.8 hours. The CBZ-epoxide half-life was 3.2 hours during HD. We conclude that HD and CVVHD provide effective clearance of CBZ and the epoxide metabolite and should be considered in the management of an acute toxic ingestion.

A successful approach to fall prevention in an outpatient hemodialysis center.

BACKGROUND AND OBJECTIVES: Hemodialysis patients are at high risk both for falling and for serious complications associated with falls, but few fall studies have specifically focused on this population. Falls occurring in an outpatient dialysis unit were reviewed to identify contributing factors and implement interventions designed to reduce fall risk. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: A root cause analysis of all fall incidents occurring at an outpatient hemodialysis center during a 4-year period was conducted. A targeted intervention program to reduce falls was then implemented. Risk of falls in the postintervention period was compared with that of the baseline period. RESULTS: In the baseline period, a total of 22 falls occurred involving 14 patients and 8 staff members or visitors (incidence of 50 falls per 100,000 dialysis treatments). Root cause analyses identified staff educational deficits and environmental hazards as the most significant risk factors for fall incidents. After an interventional period that focused on formal staff education and environmental modifications, a total of only 3 additional falls (2 patients and 1 staff member) during 21 months of follow-up (14 falls per 100,000 dialysis treatments, P = 0.01) were observed. CONCLUSIONS: Several modifiable risk factors for falls occurring in the high-risk setting of an outpatient hemodialysis unit were identified as a result of this formal analysis of fall incidents. Through a targeted series of interventions, a marked reduction in fall risk was achieved.

Single-dose daptomycin pharmacokinetics in chronic haemodialysis patients.

BACKGROUND: Daptomycin has concentration-dependent antibacterial activity against Gram-positive bacteria. Its use is increasing in haemodialysis units. The manufacturer recommends a 4-6-mg/kg dose administered every 48 hrs for patients receiving haemodialysis. However, there are no published data about daptomycin pharmacokinetics and clearance during haemodialysis. The recommended dosing regimen would conflict with asymmetric thrice-weekly haemodialysis, which yields two ~44-hr and one ~68-hr interdialytic periods. This is the first study to evaluate daptomycin pharmacokinetics in haemodialysis patients, assess the extent of daptomycin dialytic removal and model serum concentrations at 44 and 68 hrs. METHODS: Six otherwise healthy subjects on chronic haemodialysis (55.3 +/- 16.1 years old, three females, 66.2 +/- 14.2 kg) received a single 6-mg/kg dose of daptomycin post-haemodialysis infused over 30 minutes. Serial blood samples were collected for ~44 hrs (pre-next haemodialysis) and throughout the subsequent haemodialysis session with a high permeability haemodialyser. Individual pharmacokinetic parameters determined by compartmental analysis were used to model trough serum concentrations at 44 and 68 hrs with 6-, 8- and 10-mg/kg post-haemodialysis doses. RESULTS: The haemodialysis session in this trial yielded mean urea and daptomycin reduction ratios of 79.6 +/- 5.8% and 57.6 +/- 9.2%, respectively. Daptomycin half-life was 19.4 +/- 6.5 and 3.8 +/- 1.1 hrs 'off' and 'on haemodialysis', respectively, with minimal rebound 1 hr post-haemodialysis. All modelled trough concentrations at 44 and 68 hrs at all doses exceed typical minimum inhibitory concentration (MIC(90)) values for Staphylococcus aureus and Enterococcus faecalis. CONCLUSIONS: Daptomycin serum concentrations declined by ~50% after a 4-hr haemodialysis session with a high permeability haemodialyser. A 6-mg/kg i.v. post-haemodialysis thrice-weekly dose should result in sufficient pre-haemodialysis daptomycin serum concentrations even after a 68-hr interdialytic period.

Intradialytic administration of daptomycin in end stage renal disease patients on hemodialysis.

BACKGROUND AND OBJECTIVES: Infusion of intravenous antibiotics after hemodialysis (HD) may delay initiation of treatment for the next HD shift. Intradialytic administration of drugs such as vancomycin during the final hour of HD obviates these delays. Daptomycin has potent activity against Gram-positive bacteria, but the manufacturer recommends that the dose be infused after HD ends. This study determined the pharmacokinetics of intradialytically dosed daptomycin in patients with ESRD. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: This prospective crossover study compared single-dose daptomycin (6 mg/kg, 30-min intravenous infusion) pharmacokinetics administered after HD versus during the last part of HD with high-permeability (HP) and low-permeability (LP) dialyzers to seven patients who had ESRD and were on thrice-weekly HD. Serial blood samples were collected to determine daptomycin serum concentrations and protein binding. Statistical analysis was done using linear mixed model analysis. RESULTS: The maximum serum concentration observed with a 6 mg/kg post-HD dose was 61.1 +/- 7.6 microg/ml with a mean protein binding of 89.2%. Intradialytic daptomycin administration resulted in reduced maximum serum concentration and area under the curve values that were approximately 12 to 20% lower when administered during HD with LP dialyzers and approximately 35% lower with HP dialyzers. CONCLUSIONS: Intradialytic daptomycin administration during the last 30 min of HD is feasible, provided that larger dosages are used to compensate for intradialytic drug loss. On the basis of our findings, intradialytic doses of approximately 7 mg/kg (LP) or approximately 9 mg/kg (HP) theoretically should be bioequivalent to 6 mg/kg infused after HD. The calculated dosages are mathematically driven and must be validated in prospective clinical trials.

Optimizing anemia management in hospitalized patients with end-stage renal disease.

OBJECTIVE: To review available literature on the use of erythropoiesis-stimulating agents (ESAs) in patients with end-stage renal disease (ESRD) who require hospitalization and to provide recommendations for ESA use in this setting. DATA SOURCES: Primary articles were identified by English-language MEDLINE search (1966-October 2008) using the MeSH headings: kidney failure (chronic), anemia, erythropoietin, darbepoetin, hospitalization, and hematinics. Relevant data presented at recent nephrology scientific meetings (2004-October 2008) were also identified. STUDY SELECTION AND DATA EXTRACTION: Identified studies were reviewed and information regarding hospitalization, ESA use, and patient outcomes was evaluated. DATA SYNTHESIS: Studies demonstrate that hospitalized patients with ESRD usually experience a decline in hemoglobin values. Contributing factors include infection, inflammation, and untreated iron deficiency. ESAs are used inconsistently during hospitalization, with less than 50% of hospitalized patients with ESRD receiving ESA therapy in some reports. Some controversy exists regarding optimal hemoglobin targets for ESA therapy in nonhospitalized patients with ESRD, and no targets are defined for hospitalized patients. Clinical trials examining in-hospital ESA use have primarily involved the intensive care population and excluded ESRD patients. Following the patient's hospitalization, lower hemoglobin values may persist for 6 months, despite increased ESA dosing. Variability exists in frequency of hemoglobin monitoring and ESA dose changes. To date, no clinical trials have evaluated different approaches to anemia management in hospitalized patients with ESRD, and there are no published guidelines in this area. Based on published observations and clinical experience, we offer recommendations for anemia management around the time of hospitalization in an attempt to define a more rational approach to ESA therapy in this population. CONCLUSIONS: Trials are needed to define optimal ESA dosing strategies and hemoglobin targets in hospitalized patients with ESRD.