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J Michael Lazarus

Publications and source records attributed to J Michael Lazarus.

At least 19 recordsLinked to original sources
PubMed2006

Impact of the change in CMS billing rules for erythropoietin on hemoglobin outcomes in dialysis patients.

On April 1, 2006, new Centers for Medicare and Medicaid Services (CMS) rules for billing erythropoietin (EPO) for dialysis patients went into effect. Two key provisions of the rules were to cap the dose for a single patient at 500,000 IU/month and to mandate a 25% reduction in dose for patients whose latest hemoglobin (HGB) or hematocrit (HCT) in the prior month exceeded 13 g/dl or 39%, respectively. The purpose of this article is to document the effect of the rules change on HGB outcomes in a single large dialysis provider whose computer system was modified to enforce the rules. HGB and EPO doses for 5 months following the implementation were analyzed retrospectively. The most noteworthy observation is that while the rule appears to have reduced the percentage of patients with an HGB of >13 g/dl slightly, it has also increased the percentage of patients with HGB in the medically undesirable range of <11 g/dl.

Anemia↗
PubMed2006

The epidemiology of systolic blood pressure and death risk in hemodialysis patients.

BACKGROUND: This study compares the associations of predialysis systolic blood pressure (SBP) with mortality risk in both incident and prevalent hemodialysis (HD) cohorts by using both conventional and time-varying Cox analyses, thus addressing limitations of prior studies. METHODS: A total of 56,338 incident patients starting HD therapy during 1997 to 2001 and 69,590 prevalent HD patients on January 1, 2002, were grouped into the following categories: (1) SBP less than 120 mm Hg, (2) 120 < or = SBP < 140 mm Hg, (3) 140 < or = SBP < 160 mm Hg, (4) 160 < or = SBP < 180 mm Hg, (5) 180 < or = SBP < 200 mm Hg, and (6) SBP of 200 mm Hg or greater. Conventional and time-varying models evaluated 1-year and 3-year (incident patients only) survival. RESULTS: Nine percent and 26.0% of incident patients and 5.7% and 20.1% of prevalent patients were in categories 1 and 2, respectively. Their associated 1-year hazard ratios (HRs) were 2.63 to 3.68 and 1.57 to 1.68 compared with category 4, the reference group. HRs for categories 3, 5, and 6 were not different from category 4. Time-varying models magnified category 1 and 2 HRs to 5.54 to 7.42 and 1.92 to 2.21, such that 25% to 35% of patients in the target SBP range (< 140 mm Hg) had the greatest risk. A "reversed J-shaped" risk profile emerged in the time-varying models, with very high SBP (category 6) associated with HRs of 1.52 to 1.55, but only 1% of patients were in category 6. Three-year outcomes were similar. CONCLUSION: Epidemiological characteristics of predialysis SBP consistently differ from those in the general population despite different analytic perspectives. The data suggest a need for greater investigative, diagnostic, and therapeutic focus on HD patients with normal and prehypertensive blood pressure ranges.

Blood Pressure↗
PubMed2005

Activated injectable vitamin D and hemodialysis survival: a historical cohort study.

Patients with ESRD commonly experience secondary hyperparathyroidism, a condition primarily managed with activated injectable vitamin D. The biologic effects of vitamin D, however, are widespread, and it is possible that activated injectable vitamin D alters survival in ESRD. This hypothesis was tested in a historical cohort study of incident hemodialysis patients who lived throughout the United States between January 1996 and December 1999. The primary outcome was 2-yr survival among those who survived for at least 90 d after initiation of chronic hemodialysis. During this period, 51,037 chronic hemodialysis patients survived for at least 90 d from the initiation of hemodialysis, and in the ensuing 2 yr, 37,173 received activated injectable vitamin D and 13,864 did not. At 2 yr, mortality rates were 13.8/100 person-years in the group that received injectable vitamin D compared with 28.6/100 person-years in the group that did not (P < 0.001). Cox proportional hazards analyses adjusting for several potential confounders and examining injectable vitamin D therapy as a time-dependent exposure suggested that compared with patients who did not receive injectable vitamin D, the 2-yr survival advantage associated with the group that did receive injectable vitamin D was 20% (hazard ratio, 0.80; 95% confidence interval, 0.76 to 0.83). The incidence of cardiovascular-related mortality was 7.6/100 person-years in the injectable vitamin D group, compared with 14.6/100 person-years in the non-vitamin D group (P < 0.001). The benefit of injectable vitamin D was evident in 48 of 49 strata examined, including those with low serum levels of intact parathyroid hormone and elevated levels of serum calcium and phosphorus, situations in which injectable vitamin D is often withheld. Repeating the entire analysis using marginal structural models to adjust for time-dependent confounding by indication yielded a survival advantage of 26% (hazard ratio, 0.74; 95% confidence interval, 0.71 to 0.79) associated with the injectable vitamin D group. In this historical cohort study, chronic hemodialysis patients in the group that received injectable vitamin D had a significant survival advantage over patients who did not. Randomized clinical trials would permit definitive conclusions.

Calcitriol↗
PubMed2005

Epoetin alfa use in patients with ESRD: an analysis of recent US prescribing patterns and hemoglobin outcomes.

BACKGROUND: It is unknown to what degree physicians adjust erythropoietin doses to achieve hemoglobin levels (11.0 to 12.0 g/dL [110 to 120 g/L]) recommended by the National Kidney Foundation-Kidney Disease Outcomes Quality Initiative (NKF-K/DOQI) for patients with end-stage renal disease receiving hemodialysis. Our objective is to examine epoetin alfa prescribing patterns for achieving the target hemoglobin level range in this population. METHODS: Monthly hemoglobin levels and epoetin alfa doses from 2 large databases were retrospectively analyzed. One data set comprised 31,267 patients from the Fresenius Medical Care-North America (FMC-NA) database, and the other comprised 128,761 patients based on claims for Medicare services. RESULTS: Longitudinal evaluation of the FMC-NA data set showed that hemoglobin levels in patients administered epoetin alfa cycled in and out of the NKF-K/DOQI hemoglobin target range, and doses were decreased in 98.8% of patients with persistent hemoglobin levels greater than 12.0 g/dL (> 120 g/L). Hemoglobin levels in patients from the Medicare data set that initially were outside the target range migrated into the range with epoetin alfa dose titration. FMC-NA patients with a 3-month average hemoglobin level less than 11.0 g/dL (< 110 g/L) were administered significantly greater epoetin alfa doses than those with average hemoglobin levels greater than 12.0 g/dL (> 120 g/L; 21,838 versus 13,503 U/wk; P < 0.0001). Less than 0.4% of patients administered epoetin alfa were persistently anemic (hemoglobin < 11.0 g/dL [< 110 g/L]) and were administered persistently high doses (> 30,000 U/wk), but failed to respond with a 0.5-g/dL or greater (> or = 5-g/L) increase in hemoglobin levels. CONCLUSION: In these analyses, few hemodialysis patients experienced persistent anemia while being administered high epoetin alfa doses. Physicians appeared to appropriately adjust doses to achieve hemoglobin levels recommended by the NKF-K/DOQI guidelines.

Anemia↗
PubMed2005

Antibody response to Engerix-B and Recombivax-HB hepatitis B vaccination in end-stage renal disease.

Recombivax-HB (REC) and Engerix-B (ENG) are FDA-approved vaccines for hepatitis B virus (HBV) in end-stage renal disease (ESRD). This study compares antibody response rates between them in routine clinical practice. Patients completing the recommended 40 mug dose of REC (3 doses) or ENG (4 doses) between January 1, 2000 to April 30, 2003 were eligible. Patients with prior positive HBV surface antigen (HBsAg) or antibody (HBsAb) test results were excluded. The conversion rate and persistence of protective titer (HBsAb titer>or=10 IU/mL) were tracked for 1 year. A supplemental analysis of a one-to-one matched patient sample was also performed. REC patients (N=885) were older, had longer dialysis vintage, and had a larger proportion of whites than ENG patients (N=13,661). Cumulative conversion response was greater in ENG (58%) than REC (40%) at 1 year (p<0.0001). The odds ratio for response to ENG compared with REC was 1.96 (95% limits: 1.56, 2.45; p<0.0001) adjusted for age, gender, race, diabetes, vintage, BSA, hemoglobin, and eKt/V. Persistent protective HBsAb after 1 year was 77% (ENG) vs. 53% (REC). HBsAg was positive in 208 ENG patients (1.5%) with all but 1 because of transient, vaccine-related antigenemia. The difference in conversion response favoring ENG persisted in a one-to-one sample matched for age, gender, race, modality, and dialysis vintage. The study found higher seroconversion response to ENG compared with REC at several time points up to 1 year. Protective HBsAb disappeared in 23-47% of patients 1 year later, validating CDC recommendations to re-test HBsAb yearly. The observed difference in response rates may be related to the extra ENG dose given at the second month (0, 1, 2, 6 regimen). The study raises a hypothesis that requires confirmation in a prospective clinical trial.

Age Factors↗
PubMed2005

The online measurement of hemodialysis dose (Kt): clinical outcome as a function of body surface area.

BACKGROUND: Recent advances enable the direct measurement of small molecule clearance, Kecn, during each dialysis. Average Kecn and treatment length, t, are multiplied giving total clearance, Kt. The body surface area (BSA) is a fixed transformation of height and weight and is a well recognized measure of body size. This project was conceived to search for clinical outcome-based functions for measured Kt in terms of BSA to enable simple Kt prescription guidelines for clinicians who are able to measure Kecn, and to provide foundations for future clinical research. METHODS: The data came from Fresenius Medical Care (NA) files and included more than 32,000 patients with height, weight, and paired Kecn and t measurements during December 2002. Measurements were averaged for the month and used as predictor measures in Cox models of survival time during 2003. Candidate Kt values from 30 L/treatment through 70 were examined to determine the best statistical fit for quintile and decile delimited BSA groups evaluating the best fit Kt treatment target for each group. Functional forms representing the relationship between target Kt values and mean BSA of the groups were then evaluated to determine the best fit. RESULTS: Kt targets increased with BSA in a curvilinear way such that the rate of increase is greater at low BSA than high. The best statistical fit was a double reciprocal form, Kt = 1/(a + b/BSA); "a" and "b" are statistically derived coefficients. The form has an appealing mathematical property; Kt approaches 0 as BSA approaches 0. Other forms fit the data nearly as well, however, and can be used to estimate Kt targets for patients with different BSA. CONCLUSION: Empirical, outcome-based functions of measured Kt in terms of BSA exist and can be used as aids for prescribing and judging hemodialysis treatment.

Aged↗
PubMed2005

Prealbumin, mortality, and cause-specific hospitalization in hemodialysis patients.

BACKGROUND: Prealbumin (transthyretin) is a hepatic secretory protein thought to be important in the evaluation of nutritional deficiency and nutrition support. Prior studies have suggested that the serum prealbumin concentration is independently associated with mortality in hemodialysis patients, even with adjustment for serum albumin and other nutritional parameters. METHODS: To determine whether prealbumin was independently associated with mortality and morbidity (cause-specific hospitalization) in hemodialysis patients, we analyzed data on 7815 hemodialysis patients with at least one determination of serum prealbumin during the last three months of 1997. Unadjusted, case mix-adjusted, and multivariable-adjusted relative risks of death were calculated for categories of serum prealbumin using proportional hazards regression. We also determined whether the prealbumin concentration was associated with all-cause, cardiovascular, infection-related, and vascular access-related hospitalization. RESULTS: The relative risk (RR) of death was inversely related to the serum prealbumin concentration. Relative to prealbumin > or =40 mg/dL, the adjusted RRs of death were 2.41, 1.85, 1.49, and 1.23 for prealbumin <15, 15-20, 20-25, and 25-30 mg/dL, respectively. The adjusted RRs of hospitalization due to infection were 2.97, 1.95, 1.81, and 1.61 for prealbumin <15, 15-20, 20-25, and 25-30 mg/dL, respectively. The adjusted RRs of vascular access-related hospitalization were 0.48, 0.52, 0.58, and 0.71 for prealbumin <15, 15-20, 20-25, and 25-30 mg/dL, respectively. While serum albumin was strongly associated with mortality and all-cause hospitalization, it was not associated with hospitalization due to infection, and lower levels were associated with higher rather than lower rates of vascular access-related hospitalization. CONCLUSION: In hemodialysis patients, lower prealbumin concentrations were associated with mortality and hospitalization due to infection, independent of serum albumin and other clinical characteristics. Higher prealbumin concentrations were associated with vascular access-related hospitalization. In light of these findings, more intensive study into the determinants and biological actions of prealbumin (transthyretin) in end-stage renal disease is warranted.

Aged↗
PubMed2005

The emperor has no clothes (but has a catheter): a perspective on the state of chronic kidney disease care.

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

Disease Management↗
PubMed2004

Reprocessing dialysers for multiple uses: recent analysis of death risks for patients.

BACKGROUND: Reprocessing dialysers is a common cost-saving practice in the USA. It began when patients were treated with bio-incompatible cellulosic membranes that were associated with medical complications, but has continued for economic reasons despite the current use of more biocompatible non-cellulosic membranes. A dialysis services and product provider using primarily its own non-cellulosic membranes recently embarked on a staged programme to stop reprocessing dialysers. Approximately a quarter of 71,000 patients had been switched from reuse to single use by July 1, 2001. The transition offered a unique opportunity to re-evaluate death risk associated with the reuse practice. METHODS: Patients were classified as reuse or single use as of July 1, 2001. Survival time measurements started on that date (Lag0) and at four 30 day intervals after it (Lag30, Lag60, Lag90 and Lag120). Thus, patients must have been treated in their reuse group after Lag0 for at least 30, 60, 90 or 120 days, respectively. Survival time was evaluated during 1 year following the lag date using the Cox method in unadjusted, case mix-adjusted and case mix plus other measure-adjusted models. RESULTS: All analyses suggested favourable survival advantage among patients treated with single use dialysers. The differences were statistically significant at all lag times in the unadjusted models but became significant only at later lag times in the case mix- and case mix plus other measure-adjusted models. For example, single use/reuse hazard ratios in the case mix-adjusted models at Lag0-Lag120 were 0.96 (NS), 0.96 (NS), 0.94 (P = 0.02), 0.93 (P = 0.02) and 0.92 (P = 0.01), respectively. CONCLUSIONS: A risk benefit appears associated with abandonment of the dialyser reuse practice, although the benefit may lag behind the change. In the USA, the relative risk burden associated with the reprocessing of dialysers may have changed over time with the evolution of clinical practice.

Aged↗
PubMed2004

Mineral metabolism, mortality, and morbidity in maintenance hemodialysis.

Mortality rates in ESRD are unacceptably high. Disorders of mineral metabolism (hyperphosphatemia, hypercalcemia, and secondary hyperparathyroidism) are potentially modifiable. For determining associations among disorders of mineral metabolism, mortality, and morbidity in hemodialysis patients, data on 40,538 hemodialysis patients with at least one determination of serum phosphorus and calcium during the last 3 mo of 1997 were analyzed. Unadjusted, case mix-adjusted, and multivariable-adjusted relative risks of death were calculated for categories of serum phosphorus, calcium, calcium x phosphorus product, and intact parathyroid hormone (PTH) using proportional hazards regression. Also determined was whether disorders of mineral metabolism were associated with all-cause, cardiovascular, infection-related, fracture-related, and vascular access-related hospitalization. After adjustment for case mix and laboratory variables, serum phosphorus concentrations >5.0 mg/dl were associated with an increased relative risk of death (1.07, 1.25, 1.43, 1.67, and 2.02 for serum phosphorus 5.0 to 6.0, 6.0 to 7.0, 7.0 to 8.0, 8.0 to 9.0, and >/=9.0 mg/dl). Higher adjusted serum calcium concentrations were also associated with an increased risk of death, even when examined within narrow ranges of serum phosphorus. Moderate to severe hyperparathyroidism (PTH concentrations >/=600 pg/ml) was associated with an increase in the relative risk of death, whereas more modest increases in PTH were not. When examined collectively, the population attributable risk percentage for disorders of mineral metabolism was 17.5%, owing largely to the high prevalence of hyperphosphatemia. Hyperphosphatemia and hyperparathyroidism were significantly associated with all-cause, cardiovascular, and fracture-related hospitalization. Disorders of mineral metabolism are independently associated with mortality and morbidity associated with cardiovascular disease and fracture in hemodialysis patients.

Aged↗
PubMed2004

Vector length as a proxy for the adequacy of ultrafiltration in hemodialysis.

BACKGROUND: Evaluation of dialysis adequacy has focused on parameters of solute (principally urea) clearance. Relatively little attention has been paid to the adequacy of ultrafiltration. At a given phase angle, the bioimpedance vector length reflects the degree of tissue hydration, as the vector lengthens with ultrafiltration. METHODS: We determined the relative risk of death associated with different bioimpedance vector lengths in a 3009 patient hemodialysis cohort using proportional hazards regression. RESULTS: The mean phase angle was 4.8 degrees, and the mean vector length 300 +/- 70 ohm/m (range 140 to 630 ohm/m). Vector length was much longer in women than men (mean 340 vs. 270 ohm/m) and significantly longer in African Americans and patients without diabetes. Adjusted for the effects of age, gender, race, diabetes, vintage, weight, albumin, prealbumin, creatinine, hemoglobin, ferritin, and dialysis dose, the relative risk (RR) of death was 0.75 (95% CI 0.57 to 0.88) per 100 ohm/m decrease in vector length. The effect of vector length on RR was somewhat more pronounced among men (vector length x gender interaction, P= 0.07). Considering vector length of 300 to 350 ohm/m as the referent category, the RRs of death were 1.54 (95% CI 1.08 to 2.21) and 2.83 (95% CI 1.55 to 5.14) for patients with vector length 200 to 250 and <200 ohm/m, respectively. CONCLUSION: Shorter predialysis bioimpedance vectors, indicating greater soft tissue hydration, were associated with diminished survival in hemodialysis patients. These findings validate clinical observations linking longevity to maintenance of dry body weight.

Adult↗
PubMed2004

Measurement of dialyzer clearance, dialysis time, and body size: death risk relationships among patients.

BACKGROUND: Urea pharmacokinetic equation systems have contributed to better understanding of treatment dose among hemodialysis patients. The methods are indirect, however, and require the measurement of blood urea nitrogen (BUN) concentration before and after a dialysis session to estimate the total treatment dose that clinicians prescribe [urea clearance x dialysis time (Kt)] indexed to an estimate of body size [the volume of urea distribution in the body (V)] yielding the ratio, Kt/V. New technology permits direct on-line measurement of average small molecule clearance (Kecn) during each dialysis treatment that can be multiplied by time (t) to give a direct measurement of total treatment dose (Kt). This study evaluated the relationship of measured Kt with death risk. It also evaluated the relationship of simple body size measures to risk and also the combination of one such measure [body surface area (BSA)] with Kt to death risk. METHODS: The data were taken from the Fresenius Medical Care (NA) (FMCNA) clinical database that included patients who had outcome data, height and weight measurements, and at least one average Kecn and t measurement during April 2002. Kecn, t, and the body size measures [body weight, body mass index (BMI), and BSA)] were averaged during the month. Those values were used as predictors of survival during the next 1 year in unadjusted and case mix adjusted proportional hazards (Cox) models. RESULTS: Increasing values of Kecn, t, Kt and all of the body size measures were associated with lower death risk. The body size measure most closely associated with risk was the BSA that was used in subsequent models. Kt and BSA were independent risk predictors. There was a significant interaction between Kt and BSA in the case mix but not the unadjusted model indicating that the risk burden of lower total dialysis dose, Kt, may be greater among small than large patients. CONCLUSION: The direct measurement of dialysis dose during each treatment is practical and the values reported by it are clinically relevant. Higher dose was associated with better survival in both small and large patients treated three times weekly. Furthermore, smaller patients may require proportionately greater total dose than larger patients to achieve comparable survival.

Aged↗
PubMed2003

Survival of patients undergoing hemodialysis with paricalcitol or calcitriol therapy.

BACKGROUND: Elevated calcium and phosphorus levels after therapy with injectable vitamin D for secondary hyperparathyroidism may accelerate vascular disease and hasten death in patients undergoing long-term hemodialysis. Paricalcitol, a new vitamin D analogue, appears to lessen the elevations in serum calcium and phosphorus levels, as compared with calcitriol, the standard form of injectable vitamin D. METHODS: We conducted a historical cohort study to compare the 36-month survival rate among patients undergoing long-term hemodialysis who started to receive treatment with paricalcitol (29,021 patients) or calcitriol (38,378 patients) between 1999 and 2001. Crude and adjusted survival rates were calculated and stratified analyses were performed. A subgroup of 16,483 patients who switched regimens was also evaluated. RESULTS: The mortality rate among patients receiving paricalcitol was 3417 per 19,031 person-years (0.180 per person-year), as compared with 6805 per 30,471 person-years (0.223 per person-year) among those receiving calcitriol (P<0.001). The difference in survival was significant at 12 months and increased with time (P<0.001). In the adjusted analysis, the mortality rate was 16 percent lower (95 percent confidence interval, 10 to 21 percent) among paricalcitol-treated patients than among calcitriol-treated patients. A significant survival benefit was evident in 28 of 42 strata examined, and in no stratum was calcitriol favored. At 12 months, calcium and phosphorus levels had increased by 6.7 and 11.9 percent, respectively, in the paricalcitol group, as compared with 8.2 and 13.9 percent, respectively, in the calcitriol group (P<0.001). The two-year survival rate among patients who switched from calcitriol to paricalcitol was 73 percent, as compared with 64 percent among those who switched from paricalcitol to calcitriol (P=0.04). CONCLUSIONS: Patients who receive paricalcitol while undergoing long-term hemodialysis appear to have a significant survival advantage over those who receive calcitriol. A prospective, randomized study is critical to confirm these findings.

Adult↗
PubMed2003

The association between mental health, physical function, and hemodialysis mortality.

BACKGROUND: Mortality rates for individuals on chronic hemodialysis remain very high; therefore, strategies are needed to identify individuals at greatest risk for mortality so preventive strategies can be implemented. One such approach is to stratify individuals by self-reported mental health and physical function. Examining these parameters at baseline, and over time, may help identify individuals at greater risk for mortality. METHODS: We enrolled 14,815 individuals with end-stage renal disease (ESRD) and followed these individuals for up to 2 years. The mean age was 61.0 +/- 15.4 years (range, 20 to 96 years) and 31% were African Americans. The SF-36 Health Survey was administered 1 to 3 months after hemodialysis initiation and 6 months later. We examined the associations between the initial SF-36 Health Survey mental component summary (MCS) and physical component summary (PCS) scores and mortality during the follow-up period, and examined the associations between 6-month decline in PCS and MCS scores and subsequent mortality. We also examined the interactions between age and MCS and PCS scores. The general population-based mean of each of these scores was 50 with a standard deviation of 10. The main outcome measurement was death. RESULTS: Self-reported baseline mental health (MCS score) and physical function (PCS score) were both independently associated with increased mortality, and 6-month decline in these parameters was also associated with increased mortality. The multivariate hazard ratios for 1-year mortality for MCS scores of less than 30, 30 to 39, and 40 to 49 were 1.48 (95% CI, 1.32 to 1.64), 1.23 (95% CI, 1.14 to 1.32) and 1.18 (95% CI, 1.10 to 1.26) compared with a MCS score of 50 or more. The hazard ratios for PCS scores of less than 20, 20 to 29, and 30 to 39 were 1.97 (95% CI, 1.64 to 2.36), 1.62 (95% CI, 1.36 to 1.92), and 1.32 (95% CI, 1.11 to 1.57) compared with a PCS score of 50 or more. Six-month decline in self-reported mental health (hazard ratio, 1.07; 95% CI, 1.02 to 1.12, per 10-point decline in MCS score) and physical function (hazard ratio, 1.25; 95% CI, 1.18 to 1.33, per 10-point decline in PCS score) were also both significantly associated with an additional increase in mortality beyond baseline risk. We also found a significant interaction between age and physical function (P = 0.02). Specifically, there was a graded response between the PCS score category and mortality in most age strata, but this relationship was not observed in the oldest age (85 years old or older). CONCLUSION: In individuals newly initiated on chronic hemodialysis, self-reported baseline mental health and physical function are important, independent predictors of mortality, and there is a graded relationship between these parameters and mortality risk. Following these parameters over time provides additional information on mortality risk. One must also consider age when interpreting the relationship between physical function and mortality.

Adult↗
PubMed2003

The effects of higher hemoglobin levels on mortality and hospitalization in hemodialysis patients.

BACKGROUND: The introduction of recombinant human erythropoietin for the treatment of anemia of chronic renal failure provided the opportunity to correct anemia in this patient population. The optimal target hemoglobin for patients with end-stage renal disease (ESRD) remains controversial. A large database of hemodialysis patients was analyzed to determine whether increasing hemoglobin level above the current Kidney Dialysis Outcomes Quality Initiative (K/DOQI) recommendations was associated with increased risk of mortality and hospitalization. METHODS: A longitudinal study of hemodialysis patients in Fresenius Medical Care-North America facilities was performed. Selection was restricted to patients in the census for 6 consecutive months from July 1, 1998 through June 30, 2000. Patient mean hemoglobin and other covariates measured during the initial 6 months were related to survival, number of hospitalizations, and length of stay over the subsequent 6 months of follow-up. RESULTS: Patients with hemoglobin <9 g/dL had an adjusted relative risk of death of 2.11 compared to those patients with 11 </= hemoglobin < 12 g/dL (P < 0.0001). The adjusted relative risk of death was 0.84 for 12 </= hemoglobin < 13 g/dL (P = 0.007). These data suggest there is no increased risk of mortality associated with hemoglobin above the current recommended values. Both number of hospitalizations and length of stay decreased as hemoglobin increased. Patients with hemoglobin >/=13 g/dL had an adjusted length of stay of 9.6 days compared to 10.9 days for those with 11 </= hemoglobin < 12 g/dL (P < 0.0001). CONCLUSION: These data indicate the relative risk of death and hospitalization are inversely associated with hemoglobin levels, with no apparent additional risk associated with hemoglobin levels> 12 g/dL.

Adult↗
PubMed2003

Effect of variability in anemia management on hemoglobin outcomes in ESRD.

BACKGROUND: Hemoglobin (Hgb) levels fluctuate in patients with end-stage renal disease over time. This study quantified Hgb level variability and the likelihood of falling within the Hgb level goal range of 11 to 12 g/dL. Implications on the percentage of patients exceeding 3-month rolling average Hgb levels of 12, 12.5, and 13 g/dL were determined. METHODS: Phase I (n = 65,009) tracked patients with Hgb values initially outside the goal range (<11 or >12 g/dL) during 2000. Correlation with facility-specific thresholds also was evaluated. Phase II (n = 48,133) quantified variation in 3-month rolling average Hgb levels in a subset with greater than 10 months of data (mean Hgb, 11.4 +/- 1.3 g/dL). RESULTS: A total of 24,948 patients (38.4%) had Hgb levels between 11 and 12 g/dL. In only 8% did Hgb levels consistently remain less than 11 g/dL, and in 18%, greater than 12 g/dL all year. Twenty-nine percent (18,633 patients) moved from below to above target range or vice versa. Greater mean facility Hgb level correlated with a greater percentage of patients with Hgb levels greater than 10 g/dL (R2 = 0.49) and greater than 12.5 g/dL (R2 = 0.61). For facilities to have 90% or greater of patients with 3-month rolling average Hgb levels greater than 10 g/dL, 13% to 31% of patients will have 3-month rolling average Hgb values greater than 12.5 g/dL. The average individual patient is expected to have a +/-1.4-g/dL fluctuation in 3-month rolling average Hgb levels per year. Despite increased mean Hgb levels and erythropoietin (EPO) and iron use, the spread of the Hgb distribution curve remained unchanged in the last 6 years. CONCLUSION: Variability caused by laboratory assays, biological factors, and therapeutic response determines patient Hgb level variability. Improving factors that can be manipulated (eg, standardizing EPO and iron algorithms) and adjustment of the target Hgb level range, specifically, by increasing the upper bound, likely will decrease the observed variability and further enhance the quality of anemia management.

Anemia↗