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 supplementation 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 erythropoiesis into storage within the reticuloendothelial 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 purpose of this study is to evaluate the efficacy of enteral iron supplementation in critically ill patients. The hypothesis is that enteral iron supplementation will result in both an improved hematocrit and a decreased need for blood transfusion, without increasing the risk of infection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
200
Iron group
Placebo group
Weill Medical College of Cornell University
New York, New York, United States
Hematocrit
Time frame: Day 7, Day 14, Day 21, Day 28
Serum Iron Concentration
Time frame: Day 7, Day 14, Day 21, Day 28
Serum Ferritin Concentration
Time frame: Day 7, Day 14, Day 21, Day 28
Erythrocyte Zinc Protoporphyrin Concentration
Time frame: Day 7, Day 14, Day 21, Day 28
Number of Subjects That Received at Least One RBC Transfusion During Admission to the Hospital
Time frame: Throughout hospital stay up to 6 weeks
Number of Subjects That Incurred at Least One Infection Throughout Hospital Admission
Time frame: Throughout hospital stay up to 6 weeks
Instance of Drug-related Constipation Throughout Hospital Admission
Time frame: Throughout hospital stay up to 6 weeks
Average Number of Days That Subjects Were Taking Antibiotics
Time frame: Throughout hospital stay up to 6 weeks
Hospital Mortality, as Measured by Number of Subject Deaths While Admitted to Hospital
Time frame: Throughout hospital stay up to 6 weeks
Average Length of Stay in the Hospital
Time frame: Throughout hospital stay up to 6 weeks
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