Clinical trial Recruiting at 1 site Phase 4 Interventional Ages 18 and up

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.

More Sepsis trials

Quick facts

PhasePhase 4
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment200 (estimated)
SponsorMedical University of Silesia
Academic / other
Locations1 site (Katowice)
StatusRecruiting
StartedNovember 10, 2024
Main results expectedDecember 31, 2026
Study endsApril 1, 2027
Registry record updatedDecember 27, 2024
Trial IDNCT06670963 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.