Using Epoetin Alfa and Iron Derisomaltose to Treat Anemia in Sepsis Patients
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
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 |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medical University of Silesia Academic / other |
| Locations | 1 site (Katowice) |
| Trial ID | NCT06670963 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with bleeding disorders, decompensated liver disease, or those who are pregnant will not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Katowice
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.