Achievement of renal anemia KDIGO targets by two different clinical strategies - a European hemodialysis multicenter analysis.

BACKGROUND: The optimal treatment algorithm for iron therapy and the use of erythropoiesis-stimulating agents (ESA) in anemic hemodialysis (HD) patients has not been established. Hemoglobin (Hb) target levels can be achieved through more frequent intravenous (IV) iron use with lower ESA dose, or with less iron dosing but higher ESA. ESA therapy to correct anemia may result in severe arterial and venous thrombotic complications and the evidence base evaluating hard clinical outcomes related to the use of IV iron is sparse. METHODS: A total of 1247 maintenance HD patients from 12 dialysis centers in Portugal (n = 730) and Poland (n = 517) were considered. We assessed achievement of KDIGO renal anemia targets with focus on treatment strategies, which typically differ between countries. In Poland the use and dose of IV iron was 35-72% higher than that in Portugal (p <  0.001) during three consecutive months; use and dose of ESA was 61% higher in Portugal (5034 vs 3133 IU (adjusted)/week, p <  0.001). RESULTS: Mean Hb concentration was similar (11.0 vs 11.0 g/dL) in patients treated in both countries and the proportion of patients within KDIGO anemia target was 69.5% in Poland vs 65.8% in Portugal (NS). Ferritin and TSAT levels and the proportion of patients with TSAT > 20 and > 50% were both significantly higher in patients in Poland (88.8 and 14.6%) than in Portugal (76.3 and 5.7% respectively, p <  0.001). Significantly more patients in Poland had a ferritin concentration > 800 µg/L (35.6%) compared to Portugal (15.8%, p <  0.001). The ESA resistance index (ERI) was significantly higher in patients treated in Portugal (p <  0.001). Correlation analyses showed confounding by treatment indication in unadjusted models. Multiple and logistic regression analyses showed that with ferritin within KDIGO recommended range of 200-800 µg/L the odds for Hb within guidelines increased significantly. Annual gross mortality was 16% in Poland and 13% in Portugal (NS); there were no differences in cause-specific mortality. CONCLUSIONS: Administration of high doses of IV iron in routine clinical HD practice may not be associated with considerable harm. However, large randomized controlled trials are needed to provide absolute evidence of iron safety.

Pragmatic Trials in Maintenance Dialysis: Perspectives from the Kidney Health Initiative.

Pragmatic clinical trials are conducted under the real-world conditions of clinical care delivery. As a result, these trials yield findings that are highly generalizable to the nonresearch setting, identify interventions that are readily translatable into clinical practice, and cost less than trials that require extensive research infrastructures. Maintenance dialysis is a setting especially well suited for pragmatic trials because of inherently frequent and predictable patient encounters, highly granular and uniform data collection, use of electronic data systems, and delivery of care by a small number of provider organizations to approximately 90% of patients nationally. Recognizing the potential for pragmatic trials to generate much needed evidence to guide the care of patients receiving maintenance dialysis, the Kidney Health Initiative assembled a group of individuals with relevant expertise from academia, industry, and government to provide the nephrology community with information about the design and conduct of such trials, with a specific focus on the dialysis setting. Here, we review this information, and where applicable, use experience from the ongoing Time to Reduce Mortality in End Stage Renal Disease Trial, a large cluster-randomized, pragmatic trial evaluating hemodialysis session duration, to illustrate challenges and solutions to operational, ethical, and regulatory issues.

Data completeness as an unmeasured confounder in dialysis facility performance comparison with 1-year follow-up
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;Aims: Standardized mortality and hospitalization ratios (SMRs, SHRs) are used to measure dialysis facility performance in the US, with adjustment for demographics and comorbid conditions derived from the end-stage renal disease (ESRD) Medical Evidence (ME) Report. Sensitivities are low for ME-based comorbidity, and levels of under-reporting may differ among facilities. We aimed to assess the effect of data inaccuracy on performance comparison. METHODS: Using the United States Renal Data System ESRD database, we included patients who initiated hemodialysis July 1 - December 31 in each of the years 2006 - 2010, had Medicare as primary payer, were aged ≥ 66 years, and had no prior transplant. Patients were followed from dialysis initiation to the earliest of death, transplant, modality change, or 1 year. SMRs and SHRs were calculated for for-profit/non-profit and rural/urban facilities for ME-based and claims-based comorbidity, separately. Cox models were used for expected number of deaths and piecewise Poison models for expected number of hospitalizations. Comorbidity agreement was measured by κ-statistic. Testing of differences between ME-based and claims-based SMRs/SHRs was performed by bootstrap. RESULTS: In all, 73,950 incident hemodialysis patients were included. κ-values for comorbidity agreement were low, < 0.5, except for diabetes (0.77). Percentages of claims-based comorbidity were similar for for-profit and non-profit facilities; ME-based comorbidity was lower for for-profit facilities. Differences between ME-based and claims-based SMRs/SHRs were statistically significant. Compared with ME-based SMRs/SHRs, claims-based ratios decreased 0.9/0.6% for for-profit and 1/0.7% for urban facilities and increased 3.4/2.8% for non-profit and 5.9/4.1% for rural facilities. CONCLUSIONS: Comorbidity data source may affect performance evaluation. The impact is larger for smaller groups.
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Comorbidity ascertainment from the ESRD Medical Evidence Report and Medicare claims around dialysis initiation: a comparison using US Renal Data System data.

BACKGROUND: The end-stage renal disease Medical Evidence Report serves as a source of comorbid condition data for risk adjustment of quality metrics. We sought to compare comorbid condition data in the Medical Evidence Report around dialysis therapy initiation with diagnosis codes in Medicare claims. STUDY DESIGN: Observational cohort study using US Renal Data System data. SETTING & PARTICIPANTS: Medicare-enrolled elderly (≥66 years) patients who initiated maintenance dialysis therapy July 1 to December 31, 2007, 2008, or 2009. INDEX TESTS: 12 comorbid conditions ascertained from claims during the 6 months before dialysis therapy initiation, the Medical Evidence Report, and claims during the 3 months after dialysis therapy initiation. REFERENCE TEST: None. RESULTS: Comorbid condition prevalence according to claims before dialysis therapy initiation generally exceeded prevalence according to the Medical Evidence Report. The κ statistics for comorbid condition designations other than diabetes ranged from 0.06 to 0.43. Discordance of designations was associated with age, race, sex, and end-stage renal disease Network. During 23,930 patient-years of follow-up from 4 to 12 months after dialysis therapy initiation (8,930 deaths), designations from claims during the 3 months after initiation better discriminated risk of death than designations from the Medical Evidence Report (C statistics of 0.674 vs 0.616). Between the Medical Evidence Report and claims, standardized mortality ratios changed by >10% for more than half the dialysis facilities. LIMITATIONS: Neither the Medical Evidence Report nor diagnosis codes in claims constitute a gold standard of comorbid condition data; results may not apply to nonelderly patients or patients without Medicare coverage. CONCLUSIONS: Discordance of comorbid condition designations from the Medical Evidence Report and claims around dialysis therapy initiation was substantial and significantly associated with patient characteristics, including location. These patterns may engender bias in risk-adjusted quality metrics. In lieu of the Medical Evidence Report, claims during the 3 months after dialysis therapy initiation may constitute a useful source of comorbid condition data.

Medicare Advantage associated with lower mortality for incident dialysis patients.

Physicians across the care continuum are increasingly aligned around the belief that coordinated care can improve patient outcomes. As the principal caregivers for one of the most medically fragile patient groups in healthcare, nephrologists are especially attuned to the potential value of integrated care. Medicare Advantage (MA) offers one way to test this hypothesis. By law, end-stage renal disease patients currently cannot enroll into an MA plan, but if they develop ESRD while in such a plan, they may continue to be enrolled. The contrast between these patients and their counterparts who carry Medicare fee for service (MFFS) thereby represents a natural experiment that affords an opportunity to examine whether enrollment in a coordinated care system may improve outcomes. In order to promote (unbiased) comparison of patients in a non-randomized context, we propensity score-matched incident dialysis patients enrolled in MA versus those in MFFS. The data demonstrate that patients who were enrolled in an MA plan upon initiation of dialysis had a 9% lower mortality rate than their MFFS counterparts. This beneficial association of MA enrollment was found to be sustained over the first two years of dialysis treatment.

Association of pre-transplant blood pressure with post-transplant outcomes.

BACKGROUND: Previous studies have indicated U-shaped associations between blood pressure (BP) and mortality in dialysis patients. We hypothesized that a similar association exists between pre-transplant BP and post-transplant outcomes in dialysis patients who undergo successful kidney transplantation. METHODS: Data from the Scientific Registry of Transplant Recipients were linked to the five-yr cohort of a large dialysis organization in the United States. We identified all dialysis patients who received a kidney transplant during this period. Unadjusted and multivariate adjusted predictors of transplant outcomes were examined. RESULTS: A total of 13 881 patients included in our study were 47 ± 14 yr old and included 42% women. There was no association between pre-transplant systolic BP and post-transplant mortality, although a decreased risk trend was observed in those with low post-dialysis systolic BP. Compared to patients with pre-dialysis diastolic BP 70 to <80 mmHg, patients with pre-dialysis diastolic BP <50 mmHg experienced lower risk of post-transplant death (hazard ratios [HR]: 0.74, 95% CI: 0.55-0.99). However, compared to patients with post-dialysis diastolic BP 70 to <80 mmHg, patients with post-dialysis diastolic BP ≥100 mmHg experienced higher risk of death (HR: 3.50, 95% CI: 1.57-7.84). In addition, very low (<50 mmHg for diastolic BP and <110 mmHg for systolic BP) pre-transplant BP was associated with lower risk of graft loss. CONCLUSIONS: Low post-dialysis systolic BP and low pre-dialysis diastolic BP are associated with lower post-transplant risk of death, whereas very high post-dialysis diastolic BP is associated with higher mortality in kidney transplant recipients. BP variations in dialysis patients prior to kidney transplantation may have a bearing on post-transplant outcome, which warrants additional studies.

Confounders of mortality and hospitalization rate calculations for profit and nonprofit dialysis facilities: analytic augmentation.

BACKGROUND: Patient outcomes have been compared on the basis of the profit status of the dialysis provider (for-profit [FP] and not-for-profit [NFP]). In its annual report, United States Renal Data System (USRDS) provides dialysis provider level death and hospitalization rates adjusted by age, race, sex, and dialysis vintage; however, recent analyses have suggested that other variables impact these outcomes. Our current analysis of hospitalization and mortality rates of hemodialysis patients included adjustments for those used by the USRDS plus other potential confounders: facility geography (end-stage renal disease network), length of facility ownership, vascular access at first dialysis session, and pre-dialysis nephrology care. METHODS: We performed a provider level, retrospective analysis of 2010 hospitalization and mortality rates among US hemodialysis patients exclusively using USRDS sources. Crude and adjusted incidence rate ratios (IRRs) were calculated using the 4 standard USRDS patient factors plus the 4 potential confounders noted above. RESULTS: The analysis included 366,011 and 34,029 patients treated at FP and NFP facilities, respectively. There were statistical differences between the cohorts in geography, facility length of ownership, vascular access, and pre-dialysis nephrology care (p < 0.001), as well as age (p < 0.01), race (p < 0.001), and vintage (p < 0.001), but not sex (p = 0.12). When using standard USRDS adjustments, hospitalization and mortality rates for FP and NFP facilities were most disparate, favoring the NFP facilities. Rates were most similar between providers when adjustments were made for each of the 8 factors. With the FP IRR as the referent (1.0), the hospitalization IRR for NFP facilities was 1.00 (95% confidence interval [CI] 0.97-1.02; p = 0.69), while the NFP mortality IRR was 1.01 (95% CI 0.97-1.05; p = 0.64). CONCLUSIONS: These data suggest there is no difference in mortality and hospitalization rates between FP and NFP dialysis clinics when appropriate statistical adjustments are made.

ESRD special needs plans: a proof of concept for integrated care.

Since the completion of the Centers for Medicare and Medicaid Services' end-stage renal disease (ESRD) demonstration projects, passage of the Affordable Care Act, and announcement of ESRD Seamless Care Organizations (ESCOs) by CMS' Innovation Center, it seems that ESRD-centered accountable care organizations will be the future model for kidney care of Medicare beneficiaries. Regardless of what you call it--managed care organization, special needs plan, ESCO--balancing quality of health care with costs of health care will continue to be the primary directive for physicians and institutions using integrated care management (ICM) strategies to manage their ESRD patients' health. The renal community has had previous success with ICM, and these experiences could help to guide our way.

Donor race and outcomes in kidney transplant recipients.

BACKGROUND: African Americans are at greater risk to reach end-stage renal disease and this risk may carry over in a kidney transplant recipient after kidney transplantation. METHODS: Linking the five-yr patient data of a large dialysis organization to the Scientific Registry of Transplant Recipients, we identified 13 692 hemodialysis patients who underwent first kidney transplantation. Mortality or graft failure and delayed graft function risks were estimated by Cox's regression (hazard ratio [HR] and 95% confidence interval) and logistic regression, respectively. RESULTS: Patients were 48 ± 14 yr old and included 39% women and 26% patients with diabetes. After adjusting for several relevant clinical and transplant-related variables, African American donor race was associated with higher all-cause mortality, with HR of 1.39 (1.09-1.78) for all-cause mortality, 1.80 (1.17-2.76) for cardiovascular mortality, 1.30 (1.03-1.64) for death-censored graft loss and 1.31 (1.10-1.57) for combined outcome over the six-yr observation period. In the non-African American recipient subcohort, but not in the African American recipient subcohort, African American donor race was associated with higher risk of death-censored graft loss (2.24 [1.44-3.49]) in our fully adjusted model. CONCLUSIONS: African American donor race was associated with increased all-cause and cardiovascular mortality and graft loss.

Recipient-related predictors of kidney transplantation outcomes in the elderly.

BACKGROUND: It is not clear whether in old people with end-stage renal disease kidney transplantation is superior to dialysis therapy. METHODS: We compared mortality rates between kidney transplant recipients (KTRs) and the general population across different age categories. We also examined patient and allograft survival in 15 667 elderly KTRs (65-<90 yr old, 36% female) within three age subgroups (65-<70, 70-<75, and ≥75 yr). RESULTS: The rise in the relative risk of death in older age groups was substantially less in KTRs than in the general population, that is, 1.8 and 2.0 vs. 21.4 and 76.6 in those aged 65-<75 and ≥75 yr, respectively, compared with 15- to <65-yr-old people (reference group). In 65- to <70-yr-old KTRs, obesity (BMI>30 kg/m(2) ) was associated with 19% higher risk of graft failure (HR: 1.19 [1.07-1.33], p = 0.002). Diabetes was a predictor of worse patient survival in all age groups but poorer allograft outcome in the youngest age group (65-<70 yr old) only. None of the examined risk factors affected allograft outcome in the oldest group (≥75 yr old) although there was a 49% lower trend of graft failure in very old Hispanic recipients (HR: 0.51 [0.26-1.01], p = 0.05). CONCLUSIONS: Kidney transplantation may attenuate the age-associated increase in mortality, and its superior survival gain is most prominent in the oldest recipients (≥75 yr old). The potential protective effect of kidney transplantation on longevity in the elderly deserves further investigation.

A quality initiative. Reducing rates of hospitalizations by objectively monitoring volume removal.

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.

Mortality prediction by surrogates of body composition: an examination of the obesity paradox in hemodialysis patients using composite ranking score analysis.

In hemodialysis patients, lower body mass index and weight loss have been associated with higher mortality rates, a phenomenon sometimes called the obesity paradox. This apparent paradox might be explained by loss of muscle mass. The authors thus examined the relation to mortality of changes in dry weight and changes in serum creatinine levels (a muscle-mass surrogate) in a cohort of 121,762 hemodialysis patients who were followed for up to 5 years (2001-2006). In addition to conventional regression analyses, the authors conducted a ranking analysis of joint effects in which the sums and differences of the percentiles of change for the 2 measures in each patient were used as the regressors. Concordant with previous body mass index observations, lower body mass, lower muscle mass, weight loss, and serum creatinine decline were associated with higher death rates. Among patients with a discordant change, persons whose weight declined but whose serum creatinine levels increased had lower death rates than did those whose weight increased but whose serum creatinine level declined. A decline in serum creatinine appeared to be a stronger predictor of mortality than did weight loss. Assuming residual selection bias and confounding were not large, the present results suggest that a considerable proportion of the obesity paradox in dialysis patients might be explained by the amount of decline in muscle mass.

Age and the associations of living donor and expanded criteria donor kidneys with kidney transplant outcomes.

BACKGROUND: Recent studies show a survival advantage with kidney transplant in elderly patients compared with those on dialysis therapy. STUDY DESIGN: In our present study, we examined and compared the association of expanded criteria donor (ECD) kidney and living kidney donation with the outcome of kidney transplant across different ages, including elderly recipients. SETTING & PARTICIPANTS: Using the Scientific Registry of Transplant Recipients, we identified 145,470 adult kidney transplant patients. Mortality and death-censored transplant failure risks were estimated by Cox proportional regression analyses during follow-up with a median of 3.9 years. PREDICTORS: ECD kidney and living kidney donation and age compared with others. OUTCOMES: Mortality and death-censored transplant failure risk. RESULTS: Patients were aged 45 ± 16 years and included 40% women and 19% patients with diabetes. Compared with transplant recipients 55 to younger than 65 years, the fully adjusted death-censored transplant failure risk was higher in patients 75 years and older (HR, 1.30; 95% CI, 1.09-1.56), 35 to younger than 55 years (HR, 1.13; 95% CI, 1.08-1.17), and 18 to younger than 35 years (HR, 1.64; 95% CI, 1.57-1.71). Compared with non-ECD kidneys, ECD kidneys were significant predictors of mortality in nonelderly patients (18-<35 years: HR, 1.46 [95% CI, 1.19-1.77]; 35-<55 years: HR, 1.23 [95% CI, 1.14-1.32]; and 55-<65 years: HR, 1.26 [95% CI, 1.15-1.38]) and patients 65 to younger than 70 years (HR, 1.20; 95% CI, 1.05-1.36), but not in other groups of elderly patients (HRs of 1.12 [95% CI, 0.93-1.36] for 70-<75 years and 1.04 [95% CI, 0.74-1.47] for ≥75 years). Similar results were found for risk of transplant loss. Compared with deceased donor kidneys, a living donor kidney was associated with better survival in all age groups and lower transplant loss risk in patients younger than 70 years. LIMITATIONS: Unmeasured confounders cannot be adjusted for. CONCLUSIONS: For deceased donors, ECD kidneys are not associated with increased mortality or transplant failure in recipients older than 70 years. For all types of donors, the persistent association between living donor kidneys and lower all-cause mortality across all ages suggests that, if possible, elderly patients gain longevity from living donor kidney transplant.

The IMPACT (Incident Management of Patients, Actions Centered on Treatment) program: a quality improvement approach for caring for patients initiating long-term hemodialysis.

BACKGROUND: Patients beginning dialysis therapy are at risk of death and illness. The IMPACT (Incident Management of Patients, Actions Centered on Treatment) quality improvement program was developed to improve incident hemodialysis patient outcomes through standardized care. STUDY DESIGN: Quality improvement report. SETTING & PARTICIPANTS: Patients who started hemodialysis therapy between September 2007 and December 2008 at DaVita facilities using the IMPACT program (n = 1,212) constituted the intervention group. Propensity score-matched patients who initiated hemodialysis therapy in the same interval at DaVita facilities not using the IMPACT program (n = 2,424) made up the control group. QUALITY IMPROVEMENT PLAN: IMPACT intervention included a structured intake process and monitoring reports; patient enrollment in a 90-day patient education program and 90-day patient management pathway. OUTCOMES: Mean dialysis adequacy (Kt/V), hemoglobin and albumin levels, percentage of patients using preferred vascular access (arteriovenous fistula or graft), and mortality at each quarter. RESULTS: Compared with the non-IMPACT group, the IMPACT group was associated with a higher proportion of patients dialyzing with a preferred access at 90 days (0.50 [95% CI, 0.47-0.53] vs 0.47 [95% CI, 0.45-0.49]; P = 0.1) and 360 days (0.63 [95% CI, 0.61-0.66] vs 0.48 [95% CI, 0.46-0.50]; P < 0.001) and a lower mortality rate at 90 days (24.8 [95% CI, 19.0-30.7] vs 31.9 [95% CI, 27.1-36.6] deaths/100 patient-years; P = 0.08) and 360 days (17.8 [95% CI, 15.2-20.4] vs 25.1 [95% CI, 20.7-25.2] deaths/100 patient-years; P = 0.01). LIMITATIONS: The study does not determine the care processes responsible for the improved outcomes. CONCLUSIONS: Intense management of incident dialysis patients with the IMPACT quality improvement program was associated with significantly decreased first-year mortality. Focused attention to the care of incident patients is an important part of a dialysis program.

Relationship of body size and initial dialysis modality on subsequent transplantation, mortality and weight gain of ESRD patients.

BACKGROUND: Whether peritoneal dialysis (PD) treatment leads to greater weight gain than with hemodialysis (HD) and if this limits access of obese end-stage renal disease patients to renal transplantation has not been examined. We undertook this study to determine the interrelationship between body size and initial dialysis modality on transplantation, mortality and weight gain. METHODS: Time to transplantation, time to death and weight gain were estimated in a 1:1 propensity score-matched cohort of incident HD and PD patients treated in facilities owned by DaVita Inc. between 1 July 2001 through 30 June 2006 followed through 30 June 2007 (4008 pairs) in four strata of body mass index (BMI) (<18.5, 18.5-24.99, 25.00-29.99 and ≥ 30 kg/m(2)). RESULTS: Transplantation was significantly more likely in PD patients [adjusted hazards ratio (aHR) 1.48, 95% confidence interval (95% CI) 1.29-1.70]; the probability of receiving a kidney transplant was significantly higher in each strata of BMI >18.5 kg/m(2), including with BMI ≥ 30 kg/m(2) (aHR 1.45, 95% CI 1.11-1.89). PD patients had significantly lower all-cause mortality for patients with BMI 18.50-29.99 kg/m(2). Both these findings were confirmed on analyses of the entire unmatched incident cohort (PD 4008; HD 58 471). The effect of dialysis modality on weight gain was tested in 687 propensity score-matched pairs; the odds of >2, >5 or >10% weight gain were significantly lower in PD patients. CONCLUSION: Treatment with PD is less likely to be associated with a significant weight gain and does not limit the access of obese patients to renal transplantation.

Association of pre-transplant erythropoiesis-stimulating agent responsiveness with post-transplant outcomes.

BACKGROUND: The role of pre-transplant erythropoiesis-stimulating agent (ESA) responsiveness in affecting post-transplant outcomes is not clear. METHODS: Linking the 5-year patient data of a large dialysis organization to the 'Scientific Registry of Transplant Recipients', we identified 8795 hemodialyzed patients who underwent first kidney transplantation. Mortality or graft failure, delayed graft function (DGF) and acute rejection risks were estimated by Cox regression [hazard ratio (HR)] and logistic regression, respectively. RESULTS: Patients were 48 ± 14 years old and included 38% women and 36% diabetics. Compared to renal allograft recipients who were in the first quartile of pre-transplant ESA responsiveness index (ERI), i.e. ESA dose divided by hemoglobin and weight, recipients in second, third and fourth quartiles had higher adjusted graft-censored death HR (and 95% confidence intervals) of 1.7 (1.0-2.7), 1.8 (1.1-2.9) and 2.3 (1.4-3.9) and higher death-censored graft failure HR of 1.6 (1.0-2.5), 2.0 (1.2-3.1) and 1.6 (0.9-2.6), respectively. No significant association between pre-transplant ERI and post-transplant DGF or acute rejection was detected. CONCLUSIONS: Higher pre-transplant ERI during the hemodialysis treatment period was associated with worse post-transplant long-term outcomes including increased all-cause death and higher risk of graft failure.

Associations of pre-transplant anemia management with post-transplant delayed graft function in kidney transplant recipients.

BACKGROUND: Delayed graft function (DGF) complicates kidney allograft outcomes in the immediate post-transplantation period. We hypothesized that in hemodialysis patients more severe anemia, iron deficiency, the requirement for higher doses of erythropoietin-stimulating agents (ESA), or blood transfusions prior to transplantation are associated with higher risk of DGF. METHODS: Linking five-yr hemodialysis patient data of a large dialysis organization to the Scientific Registry of Transplant Recipients, we identified 11 836 hemodialysis patients. Using logistic regression analyses we examined the association between pre-transplant parameters and post-transplant DGF. RESULTS: Patients were 49 ± 14 (mean ± SD) yr old and included 38% women, 27% blacks, and 26% diabetics. After adjusting for relevant covariates, pre-transplant blood transfusion was associated with 33% higher DGF risk (odds ratio [OR] = 1.33; 95% confidence interval [CI]: 1.19-1.48); and each 5000 U/wk increase of pre-transplant ESA dose with 5% higher DGF (OR = 1.05; 95% CI: 1.02-1.09). Compared to pre-transplant blood hemoglobin of 12-12.99 g/dL, there was 25% higher risk of DGF with blood hemoglobin 10-10.99 g/dL (OR = 1.25; 95% CI: 1.01-1.55), whereas blood hemoglobin ≥13 g/dL exhibited 15% higher risk of DGF (OR = 1.15; 95% CI: 0.98-1.34). CONCLUSIONS: Pre-transplant blood transfusion, higher ESA dose, and either high or low blood hemoglobin but not iron markers are associated with higher risk of DGF.

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.

Results of a pilot program to improve phosphorus outcomes in hemodialysis patients.

OBJECTIVE: End-stage renal disease causes dysregulation of bone and mineral metabolism, including increased serum phosphorus levels. Kidney Foundation Kidney Disease Outcome Quality Initiative 2003 guidelines recommend maintaining phosphorus levels between 3.5 and 5.5 mg/dL in dialysis patients. We examined the effects of a focused phosphorus management pilot program designed to improve the percentage of hemodialysis patients achieving phosphorus levels <5.5 mg/dL. DESIGN, SETTING, SUBJECTS, AND INTERVENTION: We conducted a prospective, multicenter, single-arm study at 8 geographically diverse at-risk facilities (n = 702 hemodialysis patients) in a large U.S. dialysis organization. The focused phosphorus management program provided in-service training to staff members, and provided patients with diet and phosphorus management through in-center, 1:1 education and support, direct-to-patient adherence communications, benefit management assistance, and adherence support specific to lanthanum carbonate over a 6-month period. MAIN OUTCOME MEASURE: Facility-level markers of bone and mineral metabolism (phosphorus, parathyroid hormone, corrected calcium) and nutritional status (serum albumin, normalized protein catabolic rate) were assessed before and after program implementation. RESULTS: There was a significant increase in the percentage of patients per facility achieving phosphorus levels <5.5 mg/dL (mean ± SD at baseline = 61.6% ± 5.2%; month 6 = 71.3% ± 9.0%; P < .01) and parathyroid hormone (150 to 300 pg/mL; mean ± SD at baseline = 39.1% ± 2.4%; month 6 = 44.5% ± 7.0%; P = .04). During the course of the evaluation, mean calcium, albumin, and normalized protein catabolic rate levels did not change significantly. CONCLUSIONS: These results show proof-of-concept that a focused phosphorus management program targeting both staff members and patients can significantly improve patient outcomes without compromising nutritional status.