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• Status: Withdrawn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: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Denver Health and Hospital Authority
• Treatments: Ferric Compounds; Ferric Oxide, Saccharated; Iron

Criteria

Inclusion Criteria:

• Anemia (hemoglobin < 12 g/dL).

• Functional iron deficiency:

1. Serum iron concentration < 40 ug/dL

2. TSAT < 25%

3. Serum ferritin concentration > 28 ng/mL

• < 72 hours from ICU admission.

• Expected ICU length of stay ≥ 7 days.

Exclusion Criteria:

• Age < 18 years.

• Active bleeding requiring pRBCs transfusion

• Iron overload (serum ferritin concentration ≥ 1,500 ng/mL). The serum ferritin concentration is an acute phase reactant that is increased during critical illness regardless of total body iron [3]. Substantial levels of hyperferritinemia (serum ferrinin concentration > 1,000 ng/dL) were observed in both NCT00450177 and NCT01180894 without increased risk of infection and despite both low TSAT and IDE. For these reasons, we believe that relative hyperferritinemia (serum ferritin concentration 500 - 1,500 ng/dL) is neither harmful nor indicative of bone marrow iron availability.

• Infection, defined using US Centers for Disease Control and Prevention (CDC) guidelines, with the exception of ventilator-associated pneumonia (VAP), which is defined as clinical suspicion for pneumonia along with a lower respiratory tract culture with ≥ 105 colony forming units per mL.

• Chronic inflammatory conditions (e.g., systemic lupus erythematosis, rheumatoid arthritis, ankylosing spondilitis).

• Pre-existing hematologic disorders (e.g., thalassemia, sickle cell disease, hemophilia, von Willibrand's disease, or myeloproliferative disease).

• Macrocytic anemia (admission mean corpuscular volume ≥ 100 fL).

• Current or recent (within 30 days) use of immunosuppressive agents.

• Use of any recombinant human erythropoietin formulation within the previous 30 days.

• Pregnancy or lactation.

• Legal arrest or incarceration.

• Prohibition of pRBCs transfusion.

• Stay of ≥ 48 hours duration in the ICU of a transferring hospital.

• History of intolerance or hypersensitivity to iron.

• Moribund state in which death was imminent.