Randomized Study Comparing Ferric Carboxymaltose to Iron Sucrose to Treat Fe Deficiency in the Surgically Critically Ill
Status:
Withdrawn
Trial end date:
2017-09-01
Target enrollment:
Participant gender:
Summary
Critically ill surgical patients are observed to have a functional iron deficiency which
contributes to anemia, iron-deficient erythropoiesis, and an increased red blood cell
transfusion requirement. Previously, iron supplementation has been studied in this population
with the administration of enteral ferrous sulfate and intravenous iron sucrose but without
robust results in resolving serum and bone marrow iron debts.
Ferric carboxymaltose (FCM) is novel iron-containing complex that allows for the
administration of a large dose of iron over a short infusion period to allow for sustained
delivery of iron to target tissues with minimal hypersensitivity reactions. While there has
been reported increased efficacy and comparable safety of FCM when compared to iron sucrose
in the outpatient setting, there is no data comparing these two medications in surgical
critical illness.
The aim of this pilot trial is to compare two novel dosing schemes of these medications for
treatment of functional iron deficiency in surgical ICU patients. The investigators
hypothesize that iron supplementation with FCM, as compared to both iron sucrose and placebo,
is more effective and equally safe for replacing the serum iron debt.