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Critical care medicine · Sep 2014
Randomized Controlled Trial Multicenter StudyA Multicenter, Randomized Clinical Trial of IV Iron Supplementation for Anemia of Traumatic Critical Illness.
- Fredric M Pieracci, Robert T Stovall, Brant Jaouen, Maria Rodil, Anthony Cappa, Clay Cothren Burlew, Daniel N Holena, Ronald Maier, Stepheny Berry, Jerry Jurkovich, and Ernest E Moore.
- 1Department of Surgery, Denver Health Medical Center/University of Colorado School of Medicine, Denver, CO. 2Department of Surgery, University of Pennsylvania School of Medicine, Philadelphia, PA. 3Department of Surgery, Harborview Medical Center/University of Washington School of Medicine, Seattle, WA. 4Department of Surgery, University of Kansas Medical Center, Kansas City, KS.
- Crit. Care Med. 2014 Sep 1; 42 (9): 2048-57.
ObjectiveTo evaluate the efficacy of IV iron supplementation of anemic, critically ill trauma patients.DesignMulticenter, randomized, single-blind, placebo-controlled trial.SettingFour trauma ICUs.PatientsAnemic (hemoglobin < 12 g/dL) trauma patients enrolled within 72 hours of ICU admission and with an expected ICU length of stay of more than or equal to 5 days.InterventionsRandomization to iron sucrose 100 mg IV or placebo thrice weekly for up to 2 weeks.Measurements And Main ResultsA total of 150 patients were enrolled. Baseline iron markers were consistent with functional iron deficiency: 134 patients (89.3%) were hypoferremic, 51 (34.0%) were hyperferritinemic, and 64 (42.7%) demonstrated iron-deficient erythropoiesis as evidenced by an elevated erythrocyte zinc protoporphyrin concentration. The median baseline transferrin saturation was 8% (range, 2-58%). In the subgroup of patients who received all six doses of study drug (n = 57), the serum ferritin concentration increased significantly for the iron as compared with placebo group on both day 7 (808.0 ng/mL vs 457.0 ng/mL, respectively, p < 0.01) and day 14 (1,046.0 ng/mL vs 551.5 ng/mL, respectively, p < 0.01). There was no significant difference between groups in transferrin saturation, erythrocyte zinc protoporphyrin concentration, hemoglobin concentration, or packed RBC transfusion requirement. There was no significant difference between groups in the risk of infection, length of stay, or mortality.ConclusionsIron supplementation increased the serum ferritin concentration significantly, but it had no discernible effect on transferrin saturation, iron-deficient erythropoiesis, hemoglobin concentration, or packed RBC transfusion requirement. Based on these data, routine IV iron supplementation of anemic, critically ill trauma patients cannot be recommended (NCT 01180894).
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