Efficacy of Enteral Iron Supplementation in Critical Illness

This study has been completed.
Sponsor:
Information provided by:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00450177
First received: March 20, 2007
Last updated: March 31, 2008
Last verified: March 2008
  Purpose

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 supplamentation and risk of infection.


Condition Intervention Phase
Anemic, Critically Ill Patients
Drug: Ferrous Sulfate 325 mg PO TID, or placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • Weekly hemoglobin, days 0 -42
  • Weekly serum iron concentration, days 0 - 42
  • Weekly serum ferritin concentration, days 0 -42
  • Weekly erythrocyte zinc protoporphyrin concentration, days 0 -42
  • Blood transfusion
  • Infection
  • Drug-related Constipation
  • Drug-related nausea/vomiting
  • ICU mortality
  • Hospital mortality

Estimated Enrollment: 200
Study Start Date: January 2006
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Detailed Description:

Critical illness is characterized by the anemia of inflammation, which is partially caused by sequestration of iron from bone marrow sites of erythropoeisis into storage within the reticulendothelial 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 purose of this study is to evaluate the efficacy of enteral iron supplamentation in critically ill patients. The hypothesis is that enteral iron supplamentation will result in both an improved hematocrit and a decreased need for blood transfusion, without increasing the risk of infection.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18 years
  • Anemia (Hemoglobin > 13.0 g/dL)
  • expected ICU LOS > 4 days

Exclusion Criteria:

  • active bleeding
  • chronic inflammatory disease
  • immunosuppression
  • hematogolic disease (e.g. thalassemia)
  • prohibited from receiving bloo transfusion
  • moribund state in which death is imminent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00450177

Locations
United States, New York
Weill Medical College of Cornell University
New York, New York, United States, 10021
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: Philip S Barie, MD, MBA Weill Medical College of Cornell University
  More Information

No publications provided by Weill Medical College of Cornell University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00450177     History of Changes
Other Study ID Numbers: 052007738
Study First Received: March 20, 2007
Last Updated: March 31, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Weill Medical College of Cornell University:
iron
critical illness
anemia
infection

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on July 29, 2014