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

RecruitingPhase 4Ages 18 Years - anyAllPiotr Czempik
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In plain words

What the trial is, and whether it could suit you

Background Up to 66% of have anemia at the admission to the intensive care unit. This number increases to 95% after 72 hours of hospitalization in the intensive care unit due to illness and iatrogenic blood loss. Anemia worsens tissue oxygenation, especially in patietns with sepsis or septic shock, who already have blood flow issues. Instead of giving blood transfusions, which can have side effects, we aim to address the root causes of anemia in these patients. Sepsis can cause "inflammatory anemia" and combine with iron deficiency anemia. Current anemia treatments include drugs that stimulate red blood cell production and intravenous iron supplements. Some think that iron supplements can worsen infections by feeding pathogens, but this is not conclusively proven. Since transfused red blood cells (RBC) also contain iron, small doses of intravenous iron might help sepsis patients with iro

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📋 Eligibility rules (as published)
Inclusion criteria: 1. age ≥18, 2. diagnosed sepsis (Sepsis-3) or septic shock (Septic Shock-3), 3. hemoglobin \<120 g/L in both sexes. Exclusion criteria: 1. bleeding, 2. decompensated liver disease, 3. inherited microcytic disorders, 4. macrocytosis, 5. contraindications to pharmacological prophylaxis of VTE, 6. pregnancy, 7. allergy to epoetin alfa and/or iron derisomaltose, 8. ferritin concentration \>800 ng/mL, 9. unable to take informed consent.
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What it tests

  • Iron
  • EPO
  • 0.9 % NaCl
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Where

1 site
Uniwersyteckie Centrum Kliniczne im. prof. K. Gibińskiego Śląskiego Uniwersytetu Medycznego w Katowicach
Katowice, Poland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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