The Use of Epoetin Alfa and Iron Derisomaltose in the Treatment of Anemia in Patients With Sepsis or Septic Shock Hospitalized in the Intensive Care Unit: a Randomized Controlled Clinical Trial
Methods: This will be a randomized controlled clinical trial recruting 200 patients Inclusion Criteria: 1. age ≥18 2. diagnosed sepsis (Sepsis-3 definition) or septic shock (Septic Shock-3 definition) 3. hemoglobin \<120 g/L for both sexes Exclusion Criteria: 1. bleeding 2. decompensated liver disease 3. inherited microcytic disorders 4. macrocytosis 5. contraindications to pharmacological prophylaxis for venous thromboembolism 6. pregnancy 7. allergy to epoetin alfa and/or iron derisomaltose. 8. ferritin \>800 ng/mL. 9. inability to take consent Study Group: 1. epoetin alfa 50 u/kg IV (days 1, 3, 5, 8, 10, 12) 2. iron derisomaltose 0.2g IV when RET-He \<29.3 pg (days 1, 3, 5, 8, 10, 12) 3. algorithm for red blood cell transfusions Control Group: 1\. algorithm for red blood cell transfusions Laboratory Parameters: Initial: interleukin-6, procalcitonin, C-reactive protein, creatinine, ammonia, blood urea nitrogen, aspartate aminotransferase, alanine aminotransferase, total bilirubin, complete blood count (CBC), reticulocytes (RET), ferritin, iron, transferrin. Serial: CBC and RET (days 1, 3, 5, 8, 10, 12)
• age ≥18,
• diagnosed sepsis (Sepsis-3) or septic shock (Septic Shock-3),
• hemoglobin \<120 g/L in both sexes.