Efficacy of Enteral Iron Supplementation in Critical Illness
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Anemic, Critically Ill Patients |
Drug: Ferrous Sulfate 325 mg PO TID, or placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial of the Effects of Enteral Iron Supplementation on Anemia and Risk of Infection in Critical Illness |
- 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
| Estimated Enrollment: | 200 |
| Study Start Date: | January 2006 |
| Study Completion Date: | January 2008 |
| Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, New York | |
| Weill Medical College of Cornell University | |
| New York, New York, United States, 10021 | |
| Principal Investigator: | Philip S Barie, MD, MBA | Weill Medical College of Cornell University |
More Information
No publications provided by Weill Medical College of Cornell University
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00450177 History of Changes |
| Other Study ID Numbers: | 052007738 |
| Study First Received: | March 20, 2007 |
| Last Updated: | March 31, 2008 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Weill Medical College of Cornell University:
|
iron critical illness anemia infection |
Additional relevant MeSH terms:
|
Critical Illness Disease Attributes Pathologic Processes |
ClinicalTrials.gov processed this record on May 16, 2013