Hemodialysis international
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Randomized Controlled Trial Multicenter Study
Safety and tolerability of intravenous ferric carboxymaltose in patients with iron deficiency anemia.
There is limited safety information about ferric carboxymaltose (FCM), a new intravenous iron preparation. This randomized, crossover study compared the safety and tolerability of double-blinded intravenous doses of FCM or placebo in patients with iron deficiency anemia. Subjects (559) with iron deficiency anemia received a dose of either FCM (15 mg/kg, maximum 1000 mg) over 15 minutes or placebo on day 0. ⋯ During the first 24 hours of the treatment period, drug-related adverse events were reported in 9.3% of subjects receiving FCM and 4.8% receiving placebo. Of drug-related Grade 3 events, 4 subjects received FCM and 5 subjects received placebo. Administration of FCM (15 mg/kg, maximum of 1000 mg) over 15 minutes was well tolerated and associated with minimal risk of adverse reactions in patients with iron deficiency anemia.
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Acute renal failure with concomitant sepsis in the intensive care unit is associated with significant mortality. The purpose of this study was to determine if the timing of initiation of renal replacement therapy (RRT) in septic patients had an effect on the 28-day mortality. Retrospective data on medical intensive care unit patients with sepsis and acute renal failure requiring RRT were included. ⋯ Survival rates for the late group were 46.7%, 31.7%, and 13.3% at 14, 28, and 365 days. Upon logistic regression analysis, initiating dialysis with a BUN >100 mg/dL predicted death at 14 days (odds ratio [OR] 3.6, 95% confidence interval [CI] 1.7-7.6, P=0.001), 28 days (OR 2.6, 95% CI 1.2-5.7, P=0.01), and 365 days (OR 3.5, 95% CI 1.2-10, P=0.02). Septic patients who started dialysis with a BUN <100 mg/dL had improved mortality rates up to 1 year after initiation of dialysis in this single-center, retrospective analysis.