Pilot Study Evaluating Efficacy and Economic Advantage of Sucrosomial® Iron Post-operative Supplementation vs Standard of Care in Patients After Cardiac Surgery
Englewood Hospital and Medical Center
Summary
Primary objective: to evaluate the non-inferiority in terms of improvement of hemoglobin (Hg) levels within 30 days postoperatively between two proposed treatments. Secondary objective: to evaluate the financial costs associated with Sucrosomial® Iron treatment compared to Iron Sucrose (IV), while demonstrating non-inferiority in the improvement of hemoglobin levels, reduction in transfusion requirements, and reduction of hospital/ICU stay length
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * ICU hospitalized patients who underwent non-emergent cardiac surgery * Post operative iron deficient or anemic patients (Hb\< 12 for both men and women). * Patients following the same pre-operative protocol * Age \>18 years Exclusion Criteria: * Post operative day 1 Hg \<9 * Age \>90 years * Patients with cancer or other chronic conditions that impair erythropoiesis (e.g. MDS) * Stage 3, 4 renal disease * Intraoperative transfusion of PRBC
Interventions
- Dietary SupplementSucrosomial Iron (SI)
The Sucrosomial Iron (SI) you may receive is a considered a supplement, so it has not been approved by the U.S. Food \& Drug Administration (FDA) for sale. However, it is available for over-the-counter purchase. Sucrosomial Iron (SI) has been developed by PharmaNutra.
Location
- Englewood HospitalEnglewood, New Jersey