Clinical trial NCT00450177: Efficacy of Enteral Iron Supplementation in Critical Illness
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Anemic, Critically Ill Patients
Keywords: iron
critical illness
anemia
infection
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2007-03-21
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Hematocrit
timeFrame: Day 7, Day 14, Day 21, Day 28
measure: Serum Iron Concentration
timeFrame: Day 7, Day 14, Day 21, Day 28
measure: Serum Ferritin Concentration
timeFrame: Day 7, Day 14, Day 21, Day 28
measure: Erythrocyte Zinc Protoporphyrin Concentration
timeFrame: Day 7, Day 14, Day 21, Day 28
Secondary outcomes:
measure: Number of Subjects That Received at Least One RBC Transfusion During Admission to the Hospital
timeFrame: Throughout hospital stay up to 6 weeks
measure: Number of Subjects That Incurred at Least One Infection Throughout Hospital Admission
timeFrame: Throughout hospital stay up to 6 weeks
measure: Instance of Drug-related Constipation Throughout Hospital Admission
timeFrame: Throughout hospital stay up to 6 weeks
measure: Average Number of Days That Subjects Were Taking Antibiotics
timeFrame: Throughout hospital stay up to 6 weeks
measure: Hospital Mortality, as Measured by Number of Subject Deaths While Admitted to Hospital
timeFrame: Throughout hospital stay up to 6 weeks
measure: Average Length of Stay in the Hospital
timeFrame: Throughout hospital stay up to 6 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Medical College of Cornell University
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Philip S Barie, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pieracci FM, Henderson P, Rodney JR, Holena DN, Genisca A, Ip I, Benkert S, Hydo LJ, Eachempati SR, Shou J, Barie PS. Randomized, double-blind, placebo-controlled trial of effects of enteral iron supplementation on anemia and risk of infection during surgical critical illness. Surg Infect (Larchmt). 2009 Feb;10(1):9-19. doi: 10.1089/sur.2008.043.