Original Investigations: Dialysis Therapies
Effect of Variability in Anemia Management on Hemoglobin Outcomes in ESRD

https://doi.org/10.1053/ajkd.2003.50030Get rights and content

Abstract

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. Am J Kidney Dis 41:111-124. © 2003 by the National Kidney Foundation, Inc.

Section snippets

Methods

The study population was derived from all patients undergoing dialysis in FMCNA facilities in the United States for the period January 1 through December 31, 2000. For the first phase of the study, all FMCNA patients with more than a single Hgb value from January 1 to March 31, 2000 (first quarter [Q1], 2000), were included. All samples for laboratory values were drawn predialysis for patients on hemodialysis therapy. General characteristics of the population were determined regarding age,

Phase I: defining Hgb level distribution and tracking effects of EPO and/or iron therapy

Sixty-five thousand nine patients contributed data in the phase I cohort of the study. Population demographics are listed in Table 1.Ninety-three percent of patients were on hemodialysis therapy, and the remainder were on peritoneal dialysis therapy. Ninety-eight percent of patients were on EPO therapy, and 48% were on intravenous iron therapy. The 3-month rolling average Hgb level distribution for Q1 of 2000 is shown in Fig 1.

. Three-month rolling average Hgb level for Q1 2000 with DOQI

Discussion

We show that Hgb level variability in individual patients causes a substantial portion of dialysis patients (28%) to move both above and below the target Hgb level range during a relatively short period of follow-up. One component of this Hgb level variability is related to population or interpatient variability. This population variability is not unique to Hgb values because biological variability with a Gaussian distribution is found with nearly all laboratory measurements. In the case of Hgb

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    Address reprint requests to Eduardo Lacson, Jr, MD, Fresenius Medical Care, North America, 95 Hayden Ave, Lexington, MA 02420. E-mail: [email protected]

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