Use of Epoetin Alfa and Iron Derisomaltose in Treating Anemia in Patients with Sepsis or Septic Shock in the Intensive Care Unit: A Randomized Controlled Clinical Trial

What this Trial Is About

Researchers are investigating the treatment of anemia in patients with sepsis or septic shock who are admitted to the intensive care unit (ICU). Anemia affects up to 66% of these patients upon ICU admission and rises to 95% after 72 hours due to illness and blood loss from medical procedures. This trial aims to evaluate whether using epoetin alfa and iron derisomaltose can improve hemoglobin levels and reduce the need for red blood cell transfusions, potentially improving outcomes for patients with this mixed anemia caused by inflammation and iron deficiency. The study is a randomized controlled clinical trial involving 200 patients divided into two groups. The experimental group receives epoetin alfa intravenously based on body weight on days 1, 3, 5, 8, 10, and 12, plus iron derisomaltose intravenously at a fixed dose of 0.2g on the same days if reticulocyte hemoglobin is below 29.3 pg. Both groups follow a red blood cell transfusion decision algorithm. The control group receives only the transfusion algorithm without these medications. The epoetin alfa is administered as a bolus injection diluted in sodium chloride, and iron derisomaltose is given via infusion pump. Participants will undergo various laboratory tests including measurements of interleukin-6, procalcitonin, C-reactive protein, liver and kidney function, complete blood count, reticulocytes, ferritin, iron, and transferrin at study start and repeatedly during treatment days. Hemoglobin changes are tracked from enrollment to day 15 or until discharge, death, bleeding, or surgery. Researchers will monitor blood transfusions, mortality at multiple time points, and thrombotic events. The study runs from November 2024 to December 2026, with safety and efficacy closely evaluated throughout the ICU stay and follow-up periods.

Use of Epoetin Alfa and Iron Derisomaltose in Treatment of Anemia in Patients With Sepsis or Septic Shock: a Randomized Controlled Trial