Efficacy of Enteral Iron Supplementation in Critical Illness

Weill Cornell Medicine (WCM)

Status and phase: Completed; Phase 2

Conditions: Anemic, Critically Ill Patients

Treatments: Drug: Placebo Oral Tablet; Drug: Ferrous Sulfate

Study type: Interventional

Funder types: Other

Identifiers

NCT00450177

052007738

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups, including a placebo group

Iron Group

Experimental group

Description:

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.

Treatment:

Drug: Ferrous Sulfate

Placebo Group

Placebo Comparator group

Description:

Placebo capsule three times a day at 9 am, 1pm and 5 pm until hospital discharge or for 42 days, whichever occurs first.

Treatment:

Drug: Placebo Oral Tablet