Efficacy of Enteral Iron Supplementation in Critical Illness
- Conditions
- Anemic, Critically Ill Patients
- Interventions
- Drug: Placebo Oral Tablet
- Registration Number
- NCT00450177
- Lead Sponsor
- Weill Medical College of Cornell University
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
- Age > 18 years
- Anemia (Hemoglobin < 13.0 g/dL)
- ≤ 72 hours from hospital admission
- Current tolerance of enteral medications
- Expected ICU LOS > 5 days
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Iron Group Ferrous Sulfate 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 Oral Tablet Placebo capsule three times a day at 9 am, 1pm and 5 pm until hospital discharge or for 42 days, whichever occurs first.
- Primary Outcome Measures
Name Time Method Serum Ferritin Concentration Day 7, Day 14, Day 21, Day 28 Hematocrit Day 7, Day 14, Day 21, Day 28 Serum Iron Concentration Day 7, Day 14, Day 21, Day 28 Erythrocyte Zinc Protoporphyrin Concentration Day 7, Day 14, Day 21, Day 28
- Secondary Outcome Measures
Name Time Method Average Length of Stay in the Hospital 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 Number of Subjects That Incurred at Least One Infection 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 Instance of Drug-related Constipation Throughout Hospital Admission Throughout hospital stay up to 6 weeks Number of Subjects That Received at Least One RBC Transfusion During Admission to the Hospital Throughout hospital stay up to 6 weeks
Trial Locations
- Locations (1)
Weill Medical College of Cornell University
🇺🇸New York, New York, United States