Efficacy of Enteral Iron Supplementation in Critical Illness

Anemic, Critically Ill Patients Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00450177
• Other study ID #: 052007738
• Status: Completed
• Phase: Phase 2
• Start date: January 2006
• Est. completion date: January 2008

Study information

• Verified date: July 2019
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: January 2008
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemic, Critically Ill Patients
• Critical Illness

Intervention

Drug:
• Ferrous Sulfate
Iron group
• Placebo Oral Tablet
Placebo group

Locations

Country	Name	City	State
United States	Weill Medical College of Cornell University	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hematocrit		Day 7, Day 14, Day 21, Day 28
Primary	Serum Iron Concentration		Day 7, Day 14, Day 21, Day 28
Primary	Serum Ferritin Concentration		Day 7, Day 14, Day 21, Day 28
Primary	Erythrocyte Zinc Protoporphyrin Concentration		Day 7, Day 14, Day 21, Day 28
Secondary	Number of Subjects That Received at Least One RBC Transfusion During Admission to the Hospital		Throughout hospital stay up to 6 weeks
Secondary	Number of Subjects That Incurred at Least One Infection Throughout Hospital Admission		Throughout hospital stay up to 6 weeks
Secondary	Instance of Drug-related Constipation Throughout Hospital Admission		Throughout hospital stay up to 6 weeks
Secondary	Average Number of Days That Subjects Were Taking Antibiotics		Throughout hospital stay up to 6 weeks
Secondary	Hospital Mortality, as Measured by Number of Subject Deaths While Admitted to Hospital		Throughout hospital stay up to 6 weeks
Secondary	Average Length of Stay in the Hospital		Throughout hospital stay up to 6 weeks