Efficacy of Enteral Iron Supplementation in Critical Illness

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial of the Effects of Enteral Iron Supplementation on Anemia and Risk of Infection in Critical Illness

Conditions
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Anemic, Critically Ill Patients

Intervention / Treatment
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* Drug: Ferrous Sulfate
* Drug: Placebo Oral Tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years Anemia (Hemoglobin < 13.0 g/dL) ≤ 72 hours from hospital admission Current tolerance of enteral medications Expected ICU LOS > 5 days Exclusion Criteria: Active bleeding Chronic inflammatory disease End-stage renal disease Hematologic disorders Macrocytic anemia Current use of erythropoietin Pregnancy Prohibition of RBC transfusions Moribund state in which death is imminent Enrollment in another clinical trial

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Iron Group<br>Ferrous sulfate 325 mg either by capsule or oral solution three times a day at 9 am, 1pm and 5 pm until hospital discharge or for 42 days, whichever occurs first. | Drug: Ferrous Sulfate<br>* Iron group<br>|
| Placebo Comparator: Placebo Group<br>Placebo capsule three times a day at 9 am, 1pm and 5 pm until hospital discharge or for 42 days, whichever occurs first. | Drug: Placebo Oral Tablet<br>* Placebo group<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hematocrit |  | Day 7, Day 14, Day 21, Day 28 | 
| Serum Iron Concentration |  | Day 7, Day 14, Day 21, Day 28 | 
| Serum Ferritin Concentration |  | Day 7, Day 14, Day 21, Day 28 | 
| Erythrocyte Zinc Protoporphyrin Concentration |  | Day 7, Day 14, Day 21, Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects That Received at Least One RBC Transfusion During Admission to the Hospital |  | Throughout hospital stay up to 6 weeks | 
| Number of Subjects That Incurred at Least One Infection Throughout Hospital Admission |  | Throughout hospital stay up to 6 weeks | 
| Instance of Drug-related Constipation Throughout Hospital Admission |  | Throughout hospital stay up to 6 weeks | 
| Average Number of Days That Subjects Were Taking Antibiotics |  | Throughout hospital stay up to 6 weeks | 
| Hospital Mortality, as Measured by Number of Subject Deaths While Admitted to Hospital |  | Throughout hospital stay up to 6 weeks | 
| Average Length of Stay in the Hospital |  | Throughout hospital stay up to 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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iron, critical illness, anemia, infection