Using Epoetin Alfa and Iron Derisomaltose to Treat Anemia in Sepsis Patients
Official title: 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
Run by Medical University of Silesia · NCT06670963 · Data updated 2026-11-12
This study is testing if a combination of epoetin alfa and iron derisomaltose can help improve anemia in patients with sepsis in the ICU, instead of using blood transfusions.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Medical University of Silesia Academic / other |
| Locations | 1 site (Katowice) |
| Status | Recruiting |
| Started | November 10, 2024 |
| Main results expected | December 31, 2026 |
| Study ends | April 1, 2027 |
| Registry record updated | December 27, 2024 |
| Trial ID | NCT06670963 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 and older who have been diagnosed with sepsis or septic shock and have low hemoglobin levels.
✕Probably not a fit
Patients with bleeding disorders, decompensated liver disease, or those who are pregnant will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the effectiveness of epoetin alfa and iron derisomaltose in treating anemia among patients diagnosed with sepsis or septic shock in the intensive care unit. The study aims to address the underlying causes of anemia, which can worsen tissue oxygenation in critically ill patients, rather than relying on blood transfusions that may have adverse effects. By utilizing a randomized controlled design, the trial will assess the safety and efficacy of these treatments in improving hemoglobin levels and overall patient outcomes. The study is particularly focused on patients who develop mixed anemia due to sepsis, combining inflammatory anemia and iron deficiency anemia.
Why it matters
Potential benefit: If successful, this treatment approach could significantly improve hemoglobin levels and tissue oxygenation in critically ill patients with sepsis, potentially reducing the need for blood transfusions.
How similar studies have gone: While there is ongoing debate regarding the use of intravenous iron in infection settings, this study explores a novel combination approach that has not been extensively tested in similar patient populations.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Uniwersyteckie Centrum Kliniczne im. prof. K. Gibińskiego Śląskiego Uniwersytetu Medycznego w Katowicach
Katowice, Poland Recruiting
Study contacts
- Study coordinator: Piotr F. Czempik, MD, PhD
- Email: pczempik@sum.edu.pl
- Phone: 00487894201
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.