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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Iron Group | Experimental | 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. |
|
| Placebo Group | Placebo Comparator | Placebo capsule three times a day at 9 am, 1pm and 5 pm until hospital discharge or for 42 days, whichever occurs first. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ferrous Sulfate | Drug | Iron group |
| |
| Placebo Oral Tablet |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philip S Barie, MD, MBA | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Medical College of Cornell University | New York | New York | 10021 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19245362 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Iron Group | 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. Ferrous Sulfate: Iron group |
| FG001 | Placebo Group | Placebo capsule three times a day at 9 am, 1pm and 5 pm until hospital discharge or for 42 days, whichever occurs first. Placebo Oral Tablet: Placebo group |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Iron Group | 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. Ferrous Sulfate: Iron group |
| BG001 | Placebo Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Hematocrit | Posted | Mean | Standard Deviation | percentage of RBC in blood | Day 7, Day 14, Day 21, Day 28 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Iron Group | 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. Ferrous Sulfate: Iron group |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal upset | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Philip S. Barie, MD | Weill Cornell Medical College | 646-962-2580 | pbarie@med.cornell.edu |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| D000740 | Anemia |
| D007239 | Infections |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006402 | Hematologic Diseases |
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| ID | Term |
|---|---|
| C020748 | ferrous sulfate |
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| Drug |
Placebo group |
|
| 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 |
| Withdrawal by Primary Team |
|
Placebo capsule three times a day at 9 am, 1pm and 5 pm until hospital discharge or for 42 days, whichever occurs first.
Placebo Oral Tablet: Placebo group
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Baseline hematocrit | Mean | Standard Deviation | % of RBC in total blood volume |
|
| Baseline MCV | Mean Corpuscular Volume (MCV) | Mean | Standard Deviation | femtoliters |
|
| Baseline EBL | Estimated Blood Loss (EBL) | Mean | Standard Deviation | milliliters |
|
| Baseline RBC transfusion | Red Blood Cell (RBC) | Count of Participants | Participants |
|
| Baseline RBC transfusion | Red Blood Cell (RBC) | Mean | Standard Deviation | milliliters |
|
| Admission to enrollment | Mean | Standard Deviation | days |
|
| Admission APACHE II | Acute Physiology and Chronic Health Evaluation (APACHE): Designed to measure the severity of disease for adult patients admitted to intensive care units. The point score is calculated from a patient's age and 12 routine physiological measurements: alveolar-arterial oxygen gradient or arterial blood gasses, temperature, mean arterial pressure, pH arterial, heart rate, respiratory rate, sodium (serum), potassium (serum), creatinine, hematocrit, white blood cell count, glasgow coma scale. The APACHE score ranges from 0 to 71, with 0 indicating a higher mortality risk and 71 a lower risk. | Mean | Standard Deviation | units on a scale |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Primary | Serum Iron Concentration | Posted | Mean | Standard Deviation | mcg/mL | Day 7, Day 14, Day 21, Day 28 |
|
|
|
| Primary | Serum Ferritin Concentration | Posted | Mean | Standard Deviation | ng/mL | Day 7, Day 14, Day 21, Day 28 |
|
|
|
| Primary | Erythrocyte Zinc Protoporphyrin Concentration | Posted | Mean | Standard Deviation | micromol:mol heme | Day 7, Day 14, Day 21, Day 28 |
|
|
|
| Secondary | Number of Subjects That Received at Least One RBC Transfusion During Admission to the Hospital | Posted | Count of Participants | Participants | Throughout hospital stay up to 6 weeks |
|
|
|
|
| Secondary | Number of Subjects That Incurred at Least One Infection Throughout Hospital Admission | Posted | Count of Participants | Participants | Throughout hospital stay up to 6 weeks |
|
|
|
| Secondary | Instance of Drug-related Constipation Throughout Hospital Admission | Posted | Count of Participants | Participants | Throughout hospital stay up to 6 weeks |
|
|
|
| Secondary | Average Number of Days That Subjects Were Taking Antibiotics | Posted | Mean | Standard Deviation | days | Throughout hospital stay up to 6 weeks |
|
|
|
| Secondary | Hospital Mortality, as Measured by Number of Subject Deaths While Admitted to Hospital | Posted | Count of Participants | Participants | Throughout hospital stay up to 6 weeks |
|
|
|
| Secondary | Average Length of Stay in the Hospital | Posted | Mean | Standard Deviation | days | Throughout hospital stay up to 6 weeks |
|
|
|
| 0 |
| 97 |
| 7 |
| 97 |
| EG001 | Placebo Group | Placebo capsule three times a day at 9 am, 1pm and 5 pm until hospital discharge or for 42 days, whichever occurs first. Placebo Oral Tablet: Placebo group | 0 | 103 | 4 | 103 |
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| D006425 | Hemic and Lymphatic Diseases |
| Day 21 |
|
| Day 28 |
|
| Day 21 |
|
| Day 28 |
|
| Day 21 |
|
| Day 28 |
|