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Efficacy of Enteral Iron Supplementation in Critical Illness

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ClinicalTrials.gov Identifier: NCT00450177
Recruitment Status : Completed
First Posted : March 21, 2007
Last Update Posted : April 3, 2008
Information provided by:
Weill Medical College of Cornell University

March 20, 2007
March 21, 2007
April 3, 2008
January 2006
January 2008   (Final data collection date for primary outcome measure)
  • Weekly hemoglobin, days 0 -42
  • Weekly serum iron concentration, days 0 - 42
  • Weekly serum ferritin concentration, days 0 -42
  • Weekly erythrocyte zinc protoporphyrin concentration, days 0 -42
  • Blood transfusion
  • Infection
  • Drug-related Constipation
  • Drug-related nausea/vomiting
  • ICU mortality
  • Hospital mortality
Same as current
Complete list of historical versions of study NCT00450177 on ClinicalTrials.gov Archive Site
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Efficacy of Enteral Iron Supplementation in Critical Illness
A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial of the Effects of Enteral Iron Supplementation on Anemia and Risk of Infection in Critical Illness
The purpose of this study is to investigate the efficacy of enteral iron supplementation for improving anemia, decreasing the risk of blood transfusion, and decreasing mortality in patients who are hospitalized in the intensive care unit. This study will also address any relationship between enteral iron supplamentation and risk of infection.
Critical illness is characterized by the anemia of inflammation, which is partially caused by sequestration of iron from bone marrow sites of erythropoeisis into storage within the reticulendothelial system as ferritin. Also the majority of critically ill patients are hypoferremia, the efficacy of iron supplementation remains unknown. Furthermore, several retrospective studies have found an association between iron overload and infection. However, the relative risk/benefit profile of enteral iron supplementation with respect to infection has not been studied. The purose of this study is to evaluate the efficacy of enteral iron supplamentation in critically ill patients. The hypothesis is that enteral iron supplamentation will result in both an improved hematocrit and a decreased need for blood transfusion, without increasing the risk of infection.
Phase 2
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Anemic, Critically Ill Patients
Drug: Ferrous Sulfate 325 mg PO TID, or placebo
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Pieracci FM, Henderson P, Rodney JR, Holena DN, Genisca A, Ip I, Benkert S, Hydo LJ, Eachempati SR, Shou J, Barie PS. Randomized, double-blind, placebo-controlled trial of effects of enteral iron supplementation on anemia and risk of infection during surgical critical illness. Surg Infect (Larchmt). 2009 Feb;10(1):9-19. doi: 10.1089/sur.2008.043.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
January 2008
January 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age > 18 years
  • Anemia (Hemoglobin > 13.0 g/dL)
  • expected ICU LOS > 4 days

Exclusion Criteria:

  • active bleeding
  • chronic inflammatory disease
  • immunosuppression
  • hematogolic disease (e.g. thalassemia)
  • prohibited from receiving bloo transfusion
  • moribund state in which death is imminent
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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Weill Medical College of Cornell University
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Principal Investigator: Philip S Barie, MD, MBA Weill Medical College of Cornell University
Weill Medical College of Cornell University
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP