Efficacy of Enteral Iron Supplementation in Critical Illness

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2008-01-31

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.

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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.

Conditions

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Anemic, Critically Ill Patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Ferrous Sulfate

Intervention Type DRUG

Iron group

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.

Group Type PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type DRUG

Placebo group

Interventions

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Ferrous Sulfate

Iron group

Intervention Type DRUG

Placebo Oral Tablet

Placebo group

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No