Perihospitalization patterns of hemoglobin levels and erythropoiesis‐stimulating agent doses in US hemodialysis patients, 1998–2009

Anemia management in hemodialysis patients is of primary importance for clinicians and dialysis providers. Through a retrospective claims analysis, we studied prevalent US hemodialysis patients 1998–2009, and examined patterns of hemoglobin levels and erythropoiesis‐stimulating agent (ESA, epoetin [EPO], and darbepoetin [DPO] ) doses surrounding hospitalization events. Medicare outpatient claims were used to determine monthly ESA doses and associated hemoglobin levels. ESA dose trajectories were defined with repeated measures models incorporating an autoregressive covariance matrix that compared subsequent measurements with the index month of hospitalization, with variance component covariance matrices chosen for pair‐wise comparisons. Regarding prehospitalization hemoglobin levels, a biphasic pattern occurred in both the EPO (1998–2009, n = 161,242) and DPO (2004–2009, n = 4391) populations; levels rose from 1998 to 2004, fell thereafter in the EPO population, and fell after 2006 or 2007 in the DPO population. In the EPO population, the proportions of patients with hemoglobin less than 10 g/dL were 30.1% in 1998, 14.5% in 2004, and 28.3% in 2009; corresponding values for the DPO population were 21.0% in 2004 and 31.6% in 2009. While some degree of year‐to‐year variability occurred, EPO dose trends were less pronounced, with an apparent peak in 2004 followed by a modest decline; trends were similar for DPO. Trends in EPO dose trajectories did not completely parallel those for hemoglobin level; while EPO doses increased yearly up to 2004, doses stabilized, but did not materially decrease after 2004. No definite annual trends for DPO dose trajectories were apparent.     

Exceeding hemoglobin target levels in US hemodialysis patients receiving epoetin, 1999 to 2002

Despite emerging concerns that exceeding anemia targets with erythropoiesis stimulating agents may be risky for hemodialysis patients, the magnitude of and risk factors for the problem have received little attention, particularly regarding year-to-year comparisons. We studied monthly hemoglobin and epoetin levels in 41,101 patients aged at least 65 years who initiated hemodialysis between 1999 and 2002, with upper targets defined by hemoglobin levels of 120 and 130 g/L, respectively. While baseline hemoglobin values and epoetin doses rose from year to year, their rates of change during follow-up declined (p<0.0001). Similar patterns were seen after reaching hemoglobin levels of 110 g/L; comparing 1999 to 2002, the proportions reaching 120 and 130 g/L in the ensuing 9 months increased from 90% to 96% (p<0.0001) and from 56% to 69%, respectively (p<0.0001). Multivariate analysis showed that, while more recent years of dialysis inception and initial epoetin dose were associated with all 3 outcomes, higher baseline hemoglobin levels were associated with reaching levels of 110 and 120 g/L, but not 130 g/L. Exceeding hemoglobin level targets has become widespread in the United States and is associated with changes in epoetin dosing practices.     

Relationship between erythropoietin resistance index and left ventricular mass and function and cardiovascular events in patients on chronic hemodialysis

The response to erythropoietin (EPO) treatment varies considerably in individual patients on chronic hemodialysis. The EPO resistance index (ERI) has been considered useful to assess the EPO resistance and can be easily calculated in the clinic. The aim of this study was to investigate the association between ERI and left ventricular mass (LVM) and function and to determine whether ERI was associated with cardiovascular events in patients on hemodialysis. This study was designed prospectively. Clinical, laboratory, and echocardiographic variables were assessed in 72 patients on hemodialysis. The ERI was determined as the weekly weight-adjusted dose of EPO (U/kg/week) divided by hemoglobin concentration (g/dL). Patients were divided into three groups by tertiles of ERI. Patients with higher tertiles of ERI had a higher LVM index and lower LV ejection fraction compared with those with lower tertiles of ERI (P = 0.019 and P = 0.030, respectively). The median follow-up period was 53 months. The Kaplan-Meier plot showed increased frequency of cardiovascular events in patients with higher tertiles of ERI, compared with those with lower tertiles of ERI (P = 0.011, log-rank test). The multivariate Cox proportional hazard models showed that the ERI was the significant independent predictor of cardiovascular events (HR 3.00, 95% CI, 1.04-8.62, P = 0.042). Our data show that ERI was related with LVM index, LV systolic function and cardiovascular events in patients with hemodialysis. By monitoring of ERI, early identification of the EPO resistance may be helpful to predict the cardiovascular risk in hemodialysis patients.     

Predictors of anemia in patients on hemodialysis

Even though the use of erythropoietin and intravenous iron has improved the treatment of anemia in hemodialysis patients, a considerable proportion of these patients still have anemia. The aim of this study was to identify predictors of anemia in a hemodialysis population. In a single-center hemodialysis unit, all patients were studied with blood tests and their medication recorded during a period of 22 months. Correlations with hemoglobin (Hb) were performed with a simple regression or a t test. Variables that reached 5% significance were entered in a multiple regression analysis. Selected variables were presented in quartiles with levels of Hb. Mean Hb was 11.3 g/dL, and 53 patients (40%) had Hb<11.0 g/dL. In the simple regression analysis Hb correlated positively with s-iron, CHr, s-albumin, and doses of sevelamer, and negatively with sedimentation rate (SR), ferritin, base excess, and doses of erythropoietin. In the multiple regression analysis erythrocytes SR was the only variable that remained significant. Elevated SR is the strongest predictor of anemia in hemodialysis patients receiving adequate treatment with erythropoietin and intravenous iron. Patients using high doses of sevelamer had higher Hb levels than patients using low doses.     

Effect of alternate night nocturnal home hemodialysis on anemia control in patients with end‐stage renal disease

Nocturnal home hemodialysis (NHHD) has shown promising results in various clinical parameters. Whether NHHD provide benefit in anemia management remains controversial. This study aims to investigate whether anemia and erythropoiesis‐stimulating agent (ESA) requirement are improved in patients receiving alternate night NHHD compared with conventional hemodialysis (CHD). In this retrospective controlled study, a clinical data of 23 patients receiving NHHD were compared with 25 in‐center CHD patients. Hemoglobin level, ESA requirement, iron profile, and dialysis adequacy indexes were compared between the two groups. Hemoglobin level increased from baseline of 9.37 ± 1.39 g/dL to 11.34 ± 2.41 g/dL at 24 months (P < 0.001) and ESA requirement decreased from 103.44 ± 53.55 U/kg/week to 47.33 ± 50.62 U/kg/week (P < 0.001) in NHHD patients. ESA requirement further reduced after the first year of NHHD (P = 0.037). Standard Kt/V increased from baseline of 2.02 ± 0.28 to 3.52 ± 0.30 at 24 months (P < 0.001). At 24 months, hemoglobin level increased by 1.98 ± 2.74 g/dL in the NHHD group while it decreased by 0.20 ± 2.32 g/dL in the CHD group (P = 0.007). ESA requirement decreased by 53.49 ± 55.50 U/kg/week in NHHD patients whereas it increased by 16.22 ± 50.01 U/kg/week in CHD patients (P < 0.001). Twenty‐six percent of NHHD patients were able to stop ESA compared with none in the CHD group. Standard Kt/V showed greater increase in the NHHD group. (1.49 ± 0.36 in NHHD vs. 0.18 ± 0.31 in CHD, P = 0.005). NHHD with an alternate night schedule improves anemia and reduces ESA requirement as a result of enhanced uremic clearance. This benefit extended beyond the first year of NHHD.     

Reaching Target Hemoglobin after Hospitalization for Incident Hemodialysis Patients

Introduction:  The Kidney Disease Outcomes Quality Initiative (K/DOQI) has established target hemoglobin (Hb) level of 11–12 g/dL for all dialysis patients. For patients who leave an inpatient hospitalization with an Hb under this target, it is hypothesized that several factors contribute to the length of time required to achieve an Hb of 11 g/dL after hospitalization.
Objective:  To identify factors contributing to a decreased likelihood of reaching this target Hb.
Methods:  Using the first hospitalization of patients who initiated HD in 1999 and who were regularly treated with EPO, we identified those with a mean Hb of less than 11 g/dL on EPO claims during the same month as their index hospitalization. Patients were then followed up to see how long it took them to achieve an Hb of 11 g/dL, censored at death, re-hospitalization, a switch of modality, or suspension of EPO treatment.
Results:  A total of 6050 HD patients were identified. 3 months after hospitalization, 70% had achieved 11 g/dL, and 12% had been censored. For the remaining patients who eventually reached 11 g/dL, the average number of additional months required was 2.69 (SE of 0.09). From proportional hazards regression on the time (in months) to achieving an Hb of 11 g/dL, factors that significantly decreased the likelihood of reaching a target Hb included: a diagnosis on the index hospitalization of CHF or hepatic disease, a low Hb prior to the hospitalization, a high dose of EPO prior to the hospitalization, and a longer hospital stay.
Conclusions:  Patients with anemia after hospitalization are at high risk of both persistent anemia and rehospitalization. It is important to address patient comorbidities, to ensure adequate medication usage, and to monitor patient progress to prevent hospitalizations and potential impact on Hb levels.     

Erythropoietin‐stimulating agents in the management of anemia of end‐stage renal disease patients on regular hemodialysis: A prospective randomized comparative study from Qatar

Despite extensive use, to the best of our knowledge, no trial has simultaneously compared the three currently used erythropoietin‐stimulating agents (ESAs) in a prospective manner in the treatment of anemia of end‐stage renal disease patients. All hemodialysis patients in Qatar who were treated with short‐acting epoetin alfa or beta have been screened. Eligible patients had been prospectively randomized, either to continue on the previous regimen of epoetin or to receive darbepoetin alfa or continuous erythropoietin receptor activator (CERA) for a total period of 40 weeks. All groups were assessed at the end of the study for safety and efficacy parameters. A total of 327 eligible patients were randomized. Mean hemoglobin concentration remained constant within the recommended target range (11–12 g/dL) throughout the study in the three studied groups. The percentage of patients who reached the target range was constantly above 50% in the second half of the study among CERA group patients who also had significantly lower mean number of dose adjustments as compared with the other two groups (P = 0.001). Similarly, the number of discontinuations of ESA among epoetin, darbepoetin, and CERA groups was 17, 19, and 9, respectively (P = 0.042). The frequencies of adverse events were similar in all groups. This study has specifically compared the effect of ESA type on the variability of serum hemoglobin levels in hemodialysis patients. Furthermore, it confirmed the efficacy and safety of once monthly CERA for maintaining tight hemoglobin control within recommended target ranges.     

Pharmacologic adjuvants to epoetin in the treatment of anemia in patients on hemodialysis

Anemia is a common complication of chronic kidney disease, particularly in patients who are on dialysis. The use of recombinant human erythropoietin has led to the eradication of severe anemia in the dialysis population. Correction of anemia in these patients has been associated with better quality of life and clinical outcomes. Some hemodialysis patients have anemia that either is relatively refractory to epoetin therapy or requires very high doses of epoetin (i.e., hyporesponsiveness), despite having adequate iron stores, and are thus unable to achieve or maintain target hemoglobin levels. Several pharmacologic agents have been studied for effects on improving response to epoetin, either to counter hyporesponsiveness or simply to reduce epoetin use for purely economic reasons. This review examines the available literature regarding the efficacy of these potential pharmacologic adjuvants to epoetin in the treatment of anemia in patients on maintenance hemodialysis, with special emphasis on androgens, vitamin C (ascorbic acid), and L-carnitine. A review of published guidelines and recommendations for use of these agents in hemodialysis patients is provided.     

Dialysis patients treated with Epoetin alfa show improved anemia symptoms: A new analysis of the Canadian Erythropoietin Study Group trial

The health‐related quality of life (HRQOL) claims in the current Epoetin alfa label are based on the reanalyses of the exercise and physical function data from the Canadian Erythropoietin Study Group trial. The reanalysis was done to comply with the Food and Drug Administration's requirement of using statistical methods that are currently standard in evaluating clinical trial data. Presented here are HRQOL results associated with anemia. The Canadian Erythropoietin Study Group trial was a multicenter, double blind, randomized, placebo‐controlled trial evaluating the effects of Epoetin alfa on HRQOL in anemic hemodialysis patients. A total of 118 patients who were 18–75 years old, on hemodialysis for >3 months, who had a hemoglobin <9.0 g/dL, and did not have coronary artery disease or diabetes mellitus, were randomized to either receive placebo (n=40), or receive intravenous Epoetin alfa to achieve a target hemoglobin of 9.5–11.0 g/dL (n=40) or a target of 11.5–13.0 g/dL (n=38). Patients were followed for 6 months. The two Epoetin alfa‐treatment groups were combined for all analyses performed. This post hoc analysis was conducted using an intent‐to‐treat repeated measures mixed model analysis of variance using Bonferroni's multiplicity correction. The Epoetin alfa‐treated group showed a statistically significant improvement in the Kidney Disease Questionnaire symptom of fatigue in comparison with placebo. Additionally, the change in hemoglobin at 2 months was correlated with change in fatigue, energy, shortness of breath, and weakness, but had minimal effect on depression. These analyses confirm previously reported results, which indicate that treating hemodialysis patients with an erythropoiesis‐stimulating agent improves HRQOL.     

The effect of a change in epoetin alfa reimbursement policy on anemia outcomes in hemodialysis patients

In 1997, the Health Care Financing Administration Hematocrit Measurement Audit (HMA) program initiated use of a 3-month rolling average hematocrit (Hct) level for reimbursement of epoetin claims in hemodialysis patients, with denial of payment when this value exceeded 36.5%. This study evaluated the impact of the HMA program on anemia-related outcomes in hemodialysis patients. An observational, retrospective study of 987 hemodialysis patients from 11 dialysis centers in the United States was performed, collecting data between October 1996 and December 1997. Centers were selected from a pool of nearly all facilities in the United States, which during May 1997 satisfied one of two criteria: greater than 75% of patients at the facility had mean Hct level of > or =33% (Group A) or fewer than 50% of patients at the facility had mean Hct level of > or =33% (Group B). Each facility maintained its own anemia management practices without specific anemia management interventions as part of this study. Hct level, hemoglobin (Hb) level, and epoetin dose were analyzed to compare the pre-HMA period (October 1996 to May 1997) to the HMA period (June to December 1997) and/or for each of the five quarters of the study period. The primary study endpoint was the percentage of patients with Hct levels of > or =33% during each study quarter. The mean Hct level at baseline was 34% in Group A and 33.4% in Group B (p = 0.01). Hct levels, which were increasing before implementation of the HMA program, decreased during the HMA period (p < 0.001 and p = 0.013 in Groups A and B, respectively). The percentage of patients in Groups A and B with mean quarterly Hct levels of > or =33% decreased during the last quarter of the HMA implementation period compared to the quarter immediately preceding the start of the HMA program (p < 0.001 for both comparisons). Changes in Hb levels were similar to those seen in Hct levels. The mean epoetin dose administered decreased from 13,090 U/week at the start of the study to 11,884 U/week immediately before the HMA program took effect (p < 0.05). The HMA program adversely affected anemia treatment outcomes, regardless of whether dialysis units before HMA implementation had <50% of patients with a Hct level of > or =33% or had >75% of patients with a Hct level of > or =33%. The decline in mean weekly dose of epoetin was likely a result of withholding doses out of concern among providers about risk of reimbursement denial.     

Factors affecting anemia management in hemodialysis patients: a single-center experience

The difficulty maintaining hemoglobin (Hgb) within the targets recommended by KDOQI is widely recognized. While factors responsible for erythropoietin resistance have been widely studied, factors responsible for the marked fluctuations and the inability to maintain Hgb within the target range have only begun to be investigated. This study was a cross-sectional review of anemia management in hemodialysis patients. The purpose was to evaluate factors responsible for Hgb decreases of 0.5 or 1.0 g/dL and to determine the primary factors responsible for Hgb decreases below 11 g/dL. Hgb values and clinical events were extracted from patient management databases between January 1, 2005 and November 30, 2006. Isolated events were defined as events that occurred at least 30 days after any previous event and had Hgb measurements within 2 weeks before and after the event. Increasing hospital length of stay and surgical access intervention were the most common events that resulted in a decrease in Hgb. The most common factor present in patients with Hgb decreases below 11 g/dL was the withholding of recombinant human erythropoietin (rHuEPO) within the preceding 2 months. This was the only explanation for the decrease in Hgb to <11 g/dL in 38.5% of such events. The ability to maintain dialysis patients' Hgb in the target range is complicated by intervening acute events that require hospitalization or surgical access interventions. The withholding of rHuEPO appears to be a major factor in Hgb decreases below 11 g/dL.     

Correlates affecting survival in chronic hemodialysis patients: The combined impact of albumin and high hemoglobin levels on improving outcomes,local and national results

While national mortality rates for end‐stage renal disease (ESRD) patients remain high, for the past 4 years, lower than expected local mortality rates have been consistently seen in our facilities. Because of these progressive improvements in mortality rates, a study of 687 hemodialysis patients over a 4‐year period, 2003 through 2006, was undertaken to analyze which factors may be contributing to the enhanced survival rates. We also examined the partially overlapping United States Renal Data System clinical performance measures national data sets of hemodialysis patients for 2001 to 2004. Proportional hazards and logistic regression models were used to determine significant predictors of short‐term survival. Variables tested included hemoglobin (Hb), albumin, calcium, phosphorus, infections, hospitalizations, URR, Kt/V, erythropoietic stimulating agents (epoetin‐α) use, and comorbid conditions. The local and national models identified albumin, Hgb, and hospitalization as statistically significant predictors of survival. Local models also found years of dialysis as a significant predictor. Locally, there was a 69‐fold increase from 16.1 deaths/1000 patient years for albumin ≥4.0 with Hgb≥14.0 to 1115.9 deaths/1000 patient‐years for albumin <3.5 with Hgb<11.0. The increase nationally is a 4‐fold increase from 96 deaths/1000 patient‐years for albumin ≥4.0 with Hgb≥14.0 to 406 deaths/1000 patient‐years for albumin <3.5 with Hgb<11.0. There was no evidence that higher erythropoietic stimulating agents dose levels were associated with higher mortality rates, independent of the other significant factors. In conclusion, the findings indicate that individually higher Hgb and albumin levels are associated with increased survival, and when higher Hgb levels are in association with high albumin levels, the survival rates and hospitalizations are synergistically improved.     

The greatly misunderstood erythropoietin resistance index and the case for a new responsiveness measure

Introduction The optimal use of erythropoiesis stimulating agents (ESAs) to treat anemia in end stage renal disease remains controversial due to reported associations with adverse events. In analyzing these associations, studies often utilize ESA resistance indices (ERIs), to characterize a patient's response to ESA. In this study, we examine whether ERI is an adequate measure of ESA resistance. Methods We used retrospective data from a nonconcurrent cohort study of incident hemodialysis patients in the United States (n = 9386). ERI is defined as average weekly erythropoietin (EPO) dose per kg body weight (wt) per average hemoglobin (Hgb), over a 3‐month period (ERI = (EPO/wt)/Hgb). Linear regression was used to demonstrate the relationship between ERI and weight‐adjusted EPO. The coefficient of variation was used to compare the variability of Hgb with that of weight‐adjusted EPO to explain this relationship. This analysis was done for each quarter during the first year of dialysis. Findings ERI is strongly linearly related with weight‐adjusted EPO dose in each of the four quarters by the equation ERI = 0.0899*(EPO/wt) (range of R² = 0.97–0.98) and weakly linearly related to 1/Hgb (range of R² = 0.06–0.16). These correlations hold independent of age, sex, hgb level, ERI level, and epo‐naïve stratifications. Discussion ERI is strongly linearly related to weight‐adjusted (and nonweight‐adjusted) EPO dose by a “universal,” not patient‐specific formula, and thus is a surrogate of EPO dose. Therefore, associations between ERI and clinical outcomes are associations between a confounded EPO dose and those outcomes.     

Monthly continuous erythropoietin receptor activator treatment maintains stable hemoglobin levels in routine clinical management of hemodialysis patients

Once-monthly administration of CERA, a continuous erythropoietin receptor activator, has shown equivalent efficacy to shorter-acting erythropoiesis-stimulating agents (ESAs) that require more frequent dosing, but data on routine use of once-monthly CERA in hemodialysis patients are lacking. Study on Efficacy, Safety and Applicability of Mircera (SESAM) was a prospective, multicenter, noninterventional trial with a duration of up to 9 months (month 0-5 "titration phase"; month 6-8 "evaluation phase") to test the stability of Hb control in hemodialysis patients under routine conditions. Patient selection, Hb targets and CERA dosing were at the discretion of the local nephrologist. 918 patients from 92 German nephrology centers were included. Ninety-three percent were on ESA treatment prior to study entry. The mean number of CERA dose changes during the study was 1.9 ± 1.9 per patient. Mean Hb level was 11.4 ± 1.2 g/dL at baseline and 11.7 ± 1.4 g/dL at the end of the 8-month study. During the evaluation phase (months 6-8), 15.6%, 40.3%, and 66.0% of patients had stable Hb (i.e., at least two values) in the ranges 11-12, 10-12, and 10-13 g/dL, respectively. The mean intra-individual fluctuation in Hb was 1.4 ± 0.7 g/dL during the study (0.5 ± 0.4 g/dL during the 3-month evaluation phase). More than 90% of patients, and > 80% of physicians, rated CERA therapy as "very good" or "good" throughout the study. Four patients (0.4%) discontinued prematurely due to adverse drug reactions. Once-monthly CERA therapy maintains stable Hb values with low intra-individual variability and few dose adaptations in hemodialysis patients when administered entirely according to local practice, and the regimen was well-tolerated.     

The morbidity and cost implications of hemodialysis clinical performance measures

Clinical performance measures, including dialysis dose, hemoglobin, albumin, and vascular access, are the focus of monitoring and quality improvement activities. However, little is known about the implications of clinical performance measures for hospital utilization and health care costs. We obtained clinical performance measures and hospitalization records for a national random sample of 10,650 hemodialysis patients and analyzed the relationship between changes in clinical performance measures and hospital utilization after adjustment for patient demographic and medical characteristics. Higher hemoglobin, higher albumin, and fistula or graft use were independently associated with fewer hospitalizations, fewer hospital days, and decreased Medicare inpatient reimbursement. For example, a 0.5 g/dL higher hemoglobin, a 0.25 g/dL higher albumin, fistula use, and graft use were associated with hospitalization rate ratios of 0.90 (95% confidence interval 0.85, 0.96), 0.64 (0.53, 0.77), 0.60 (0.52, 0.69), and 0.79 (0.71, 0.89), respectively. Moreover, there was a 2-3-fold variation in hospital utilization across end-stage renal disease networks that was still evident after adjustment for patient characteristics and clinical performance measures. Clinical performance measures, especially albumin and vascular access, are strongly associated with hospital utilization and health care costs. These results highlight the importance of targeting nutrition and vascular access in quality improvement efforts. The marked variation in hospital utilization across networks deserves further examination.     

Challenges of providing maintenance hemodialysis in a resource poor country: Experience from a single teaching hospital in Lagos,Southwest Nigeria

Providing maintenance hemodialysis is associated with high costs and poor outcomes. In Nigeria, more than 90% of the population lives below the poverty line, and patients with end‐stage renal disease (ESRD) pay out‐of‐pocket for maintenance hemodialysis. To highlight the challenges of providing maintenance hemodialysis for patients with ESRD in Nigeria, we reviewed records of all patients who joined the maintenance hemodialysis program of our dialysis unit over a 21‐month period. Information regarding frequency of hemodialysis, types of vascular access for dialysis, mode of anemia treatment and frequency of blood transfusion received were retrieved. One hundred and twenty patients joined the maintenance hemodialysis program of our unit during the period under review. Seventy‐two (60%) were males and the mean age of the study population was 47 + 14 years. The mean hemoglobin concentration at commencement of dialysis was 7.3 g/dL + 1.6 g/dL. The initial vascular access was femoral vein cannulation in all the patients. A total of 73.5% of the patients required blood transfusion at some point with 33% receiving five or more pints of blood. Only 3.3% of the patients had thrice weekly dialysis, 21.7% dialyzed twice weekly, 23.3% once weekly, 16.7% once in two weeks, 2.5% once in three weeks and 11.7% once monthly. At the time of review, 8.3% of the patients had died while 38.3% were lost to follow‐up. Majority of patients with ESRD on maintenance hemodialysis in our unit were poorly prepared for dialysis, were under‐dialyzed, and were frequently transfused with blood with resultant poor outcomes.     

Effect of hemodiafiltration with endogenous reinfusion on overt idiopathic chronic inflammation in maintenance hemodialysis patients: A multicenter longitudinal study

Chronic inflammation is widely diffuse in maintenance hemodialysis (MHD) patients and is associated with poor survival. Hemodiafiltration with endogenous reinfusion (HFR) is a dialysis technique, highly biocompatible, able to adsorb proinflammatory cytokines and to decrease amino acids and antioxidants loss. These features could be helpful in MHD patients affected by idiopathic chronic inflammation, but this issue remains to be elucidated. We performed a multicenter longitudinal study to assess the effect of the switching from bicarbonate HD to HFR in patients with serum C‐reactive Protein (CRP) > 5 mg/L coupled with albumin <4.0 g/dL in the last 6 months. We enrolled 24/176 (14%) patients, of which 20 patients were assessed at 4 months and 18 completed the study. We excluded 11 patients with evident causes of inflammation. At baseline, serum levels of CRP (18.7[7.0–39.4] mg/L) and albumin (3.5[3.3–3.7] g/dL) were significantly correlated (r = ?0.49; P = 0.028). The effect on CRP and albumin was almost evident in the first 4 months and remained stable until to eighth month. A strict correlation (R = ?0.49; 0.040) between percentage change of CRP (?35%) and albumin (+14%) after 8 months of HFR. These effects were associated with the reduction of IL‐6, IL‐1β, and TNF‐α and the increment of pre‐albumin and leptin, whereas the serum levels of Branched Chain Amino Acid (BCAA) remained unchanged. In MHD patients affected by idiopathic chronic inflammation the switching from BHD to HFR is associated with improvement of inflammation. Whether these favorable effects may modify the outcomes of these high‐risk patients needs to be confirmed by studies ad hoc.     

Survival and other clinical outcomes of maintenance hemodialysis patients in Taiwan: A 5‐year multicenter follow‐up study

The increasing aging and diabetes mellitus (DM) patients in dialysis population make the quality maintenance of dialysis an imperative issue. Recently, an increasing number of dialysis centers were run by private dialysis providers, many of which apply quality assurance programs and performance management systems to dialysis care. We studied patients in dialysis facilities in Taiwan run by a private chain to see clinical outcomes of centers operating under these systemic strategies. Hemodialysis patients from January 1, 2008 to December 31, 2012 in 25 dialysis facilities in Taiwan, which received the management and consultation from a dialysis service provider, NephroCare (NC), were included. Data pivotal to quality of dialysis were analyzed. During a 5‐year interval, 5161 hemodialysis patients were included. For volume control, the proportion of patients with weight gain ≥4.5% decreases from 41.7% to 30.2%. Mean Kt/V is 1.74 ± 0.28. Mean albumin level is 3.92 ± 0.38 g/dL. Patients with phosphate <5.5 mg/dL is up to 71.8%. The mean hemoglobin level is 10.70 ± 1.40 g/dL. More than 80% of patients have adequate iron status. Further, 73% of patients use native arteriovenous fistula. Hospitalization‐free survival rate was 56% at the fifth year. Patient survival rate at the fifth year was 66.4%. Overall clinical performances were maintained very stable in NC facilities from this temporal data analysis. The hospitalization and survival rate also compare favorably with those reported internationally. These results warrant further studies to justify the application of this kind of quality assurance programs and performance management systems in dialysis care.     

Global ESRD Costs Associated with a Short Daily Hemodialysis Program in the United States

In spite of the growing evidence that daily hemodialysis (DHD) improves clinical outcomes and quality of life, the additional dialysis costs are not currently reimbursed in the United States. Nor have there been reports of the effects of DHD on end-stage renal disease (ESRD) global costs, which would help predict the financial impact of DHD on the ESRD program. Since 1996, 22 patients (20 in-center, 2 home) have switched from conventional thrice-weekly dialysis to short, daily dialysis with six treatments per week. Eighteen patients started for medical indications, and four started for nonmedical reasons. Causes of ESRD were the following: diabetes mellitus (6), hypertension (4), glomerulonephritis (6), hereditary (2), and other (4). Mean age was 56 ± 16 years. Patients had an average of 3.3 major comorbidities. Weekly conventional HD dialysis times were divided into six DHD treatments, each 2.0 ± 0.3 hours. Weekly Kt/V remained unchanged. Twenty-two patients were followed on DHD for 220 patient-months: 7 patients died after 1.8 ± 1.3 months, 2 were transplanted at 4.3 ± 3.2 months, and 2 discontinued DHD at 3.6 ± 4.8 months. Eleven patients remain on DHD at 17.4 ± 8.3 months. Actual costs per extra dialysis session are as follows: $14.30 for supplies and $3.20 for labor for setup/cleanup time (15 minutes at $12.80/hour). Annualized DHD savings are based on comparison of doses of epoetin alpha (Epogen) and blood pressure medication at the start and after 12 months of DHD. Hospitalization rates include all enrolled patients, comparing rates for the 12 months prior to DHD with the first year on DHD, or annualized rates for those on DHD less than one year. Cost assumptions are $9/ 1000 U Epogen, $1/blood pressure pill, and $1200/per day of hospitalization. Extra transportation costs were covered by the patients. No increased access problems were observed. For patients on short DHD longer than 12 months, supply and labor costs increased to $2733/patient/year; however, Epogen use was reduced 55%, and blood pressure medications were reduced 40%. For all patients who switched to DHD, hospitalization rates were reduced 24%. This resulted in a net savings of about $4241/patient/ year after 12 months on DHD. Overall ESRD costs were substantially decreased on DHD. These cost savings must be passed on to providers before DHD becomes more widely available.     

The Clinical Impact of Increasing the Hemodialysis Dose

Good evidence suggests that improvements in dialysis efficiency reduce morbidity and mortality of hemodialysis (HD) patients. Dialysis efficiency has also been related to better control of arterial blood pressure (BP), anemia, and serum phosphorus levels, and to improvement in patients' nutritional status. Over a 2‐year period, the present self‐controlled study of 34 HD patients (23 men, 11 women; age, 52.6 ± 14.5 years; HD duration, 55.9 ± 61.2 months) looked at the effect on clinical and laboratory parameters of increasing the delivered dialysis dose under a strict dry‐weight policy. Dialysis dose was increased without increasing dialysis time and frequency. A statistically significant increase was seen in delivered HD dose: the urea reduction ratio (URR) increased to 60% ± 10% from 52% ± 8%, and then to 71% ± 7% (p < 0.001); Kt/V_urea increased to 1.22 ± 0.28 from 0.93 ± 0.19, and then to 1.55 ± 0.29 (p < 0.001). A statistically significant increase in hemoglobin concentration also occurred—to 10.8 ± 1.9 g/dL from 10.4 ± 1.7 g/dL, and then to 11.0 ± 1.3 g/dL (p < 0.05 as compared to baseline)—with no significant difference in weekly erythropoietin dose. Statistically significant decreases occurred in the systolic and diastolic blood pressures during the first year; they then remained unchanged. Systolic blood pressure decreased to 131 ± 23 mmHg from 147 ± 24 mmHg (p < 0.001); diastolic blood pressure decreased to 65 ± 11 mmHg from 73 ± 12 mmHg (p < 0.001). Serum albumin increased insignificantly to 4.4 ± 0.4 g/dL from 4.3 ± 0.4 g/dL, and then significantly to 4.6 ± 0.3 g/dL (p = 0.002 as compared to both previous values). Normalized protein catabolic rate increased significantly to 1.16 ± 0.15 g/kg/day from 0.93 ± 0.16 g/kg/ day (p < 0.001), and then to 1.20 ± 0.17 g/kg/day (p < 0.001 as compared to baseline). We conclude that the increases achieved in average Kt/V_urea per hemodialysis session by increasing dialyzer membrane area, and blood and dialysate flows, without increasing dialysis time above 4 hours, in patients hemodialyzed thrice weekly, coupled with strict dry‐weight policy, resulted in improvements in hypertension, nutritional status, and anemia.