TY - JOUR
T1 - A multicenter, randomized clinical trial of IV iron supplementation for anemia of traumatic critical illness
AU - Pieracci, Fredric M.
AU - Stovall, Robert T.
AU - Jaouen, Brant
AU - Rodil, Maria
AU - Cappa, Anthony
AU - Burlew, Clay Cothren
AU - Holena, Daniel N.
AU - Maier, Ronald
AU - Berry, Stepheny
AU - Jurkovich, Gregory
AU - Moore, Ernest E.
PY - 2014/1/1
Y1 - 2014/1/1
N2 - Objective: To evaluate the efficacy of IV iron supplementation of anemic, critically ill trauma patients. Design: Multicenter, randomized, single-blind, placebo-controlled trial. Setting: Four trauma ICUs. Patients: Anemic (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. Interventions: Randomization to iron sucrose 100 mg IV or placebo thrice weekly for up to 2 weeks. Measurements and Main Results: A 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. Conclusions: Iron 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).
AB - Objective: To evaluate the efficacy of IV iron supplementation of anemic, critically ill trauma patients. Design: Multicenter, randomized, single-blind, placebo-controlled trial. Setting: Four trauma ICUs. Patients: Anemic (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. Interventions: Randomization to iron sucrose 100 mg IV or placebo thrice weekly for up to 2 weeks. Measurements and Main Results: A 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. Conclusions: Iron 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).
KW - anemia
KW - iron supplementation
KW - iron-deficient erythropoiesis
KW - randomized clinical trial
KW - red blood cell transfusion
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U2 - 10.1097/CCM.0000000000000408
DO - 10.1097/CCM.0000000000000408
M3 - Article
C2 - 24797376
AN - SCOPUS:84906789925
VL - 42
SP - 2048
EP - 2057
JO - Critical Care Medicine
JF - Critical Care Medicine
SN - 0090-3493
IS - 9
ER -