Ignite Creation Date:
2024-05-05 @ 5:27 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00450177
Status:
COMPLETED
Last Update Posted:
2019-07-18
First Post:
2007-03-20
Brief Title:
Efficacy of Enteral Iron Supplementation in Critical Illness
Sponsor:
Weill Medical College of Cornell University
Organization:
Weill Medical College of Cornell University
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 riskbenefit 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None