title: A multicenter, randomized clinical trial of IV iron supplementation for anemia of traumatic critical illness*.
abstract: OBJECTIVE
  To evaluate the efficacy of IV iron supplementation of anemic, critically ill trauma patients.
  
  
  METHODS
  Multicenter, randomized, single-blind, placebo-controlled trial.
  
  
  METHODS
  Four trauma ICUs.
  
  
  METHODS
  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.
  
  
  METHODS
  Randomization to iron sucrose 100 mg IV or placebo thrice weekly for up to 2 weeks.
  
  
  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).
authors.affiliation: 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.
authors.forename: Fredric M
authors.initials: FM
authors.lastname: Pieracci
authors.forename: Robert T
authors.initials: RT
authors.lastname: Stovall
authors.forename: Brant
authors.initials: B
authors.lastname: Jaouen
authors.forename: Maria
authors.initials: M
authors.lastname: Rodil
authors.forename: Anthony
authors.initials: A
authors.lastname: Cappa
authors.forename: Clay Cothren
authors.initials: CC
authors.lastname: Burlew
authors.forename: Daniel N
authors.initials: DN
authors.lastname: Holena
authors.forename: Ronald
authors.initials: R
authors.lastname: Maier
authors.forename: Stepheny
authors.initials: S
authors.lastname: Berry
authors.forename: Jerry
authors.initials: J
authors.lastname: Jurkovich
authors.forename: Ernest E
authors.initials: EE
authors.lastname: Moore
mesh_terms: D018806:APACHE; D061605:Administration, Intravenous; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000740:Anemia / Q000188:drug therapy*; D016638:Critical Illness; D017707:Erythrocyte Transfusion; D004920:Erythropoiesis / Q000502:physiology; D005260:Female; D005290:Ferric Compounds / Q000008:administration & dosage / Q000627:therapeutic use*; D000077605:Ferric Oxide, Saccharated; D005937:Glucaric Acid / Q000008:administration & dosage / Q000627:therapeutic use*; D006397:Hematinics / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D007362:Intensive Care Units / Q000706:statistics & numerical data*; D008297:Male; D008875:Middle Aged; D011524:Protoporphyrins / Q000097:blood; D016037:Single-Blind Method; D014168:Transferrin / Q000378:metabolism; D014193:Trauma Centers; D055815:Young Adult
chemical_list: D005290:Ferric Compounds; D006397:Hematinics; D011524:Protoporphyrins; D014168:Transferrin; C017803:zinc protoporphyrin; D000077605:Ferric Oxide, Saccharated; D005937:Glucaric Acid