NCT06670963 Use of Epoetin Alfa and Iron Derisomaltose in Treatment of Anemia in Patients With Sepsis or Septic Shock: a Randomized Controlled Trial
| NCT ID | NCT06670963 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Piotr Czempik |
| Condition | Anemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-11-10 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 200 participants in total. It began in 2024-11-10 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 iron deficiency. There is a need for a study on the effects of epoetin alfa and iron derisomaltose on hemoglobin (Hb) levels in sepsis patients. Hypothesis and Aim Treating anemia in sepsis patients could increase Hb levels and reduce RBC transfusions, improving patient outcomes. This study aims to evaluate the effects of epoetin alfa ± iron derisomaltose on Hb levels and RBC transfusion rates. Primary Endpoints: 1\. Hb difference at study exit (discharge from ICU/death/bleeding/need for surgery/day 15 whatever comes first) and day 1 corrected for Hb increase due to possible RBC transfusion Secondary Endpoints: 1. Hb difference on days 8 and 1 corrected for Hb increase due to possible RBC transfusion 2. Hb difference on days 15 and 1 corrected for Hb increase due to possible RBC transfusion 3. number of blood transfusions 4. percentage of patients receiving at least one blood transfusion 5. actual vs. predicted mortality 6. prevalence of deep vein thrombosis and pulmonary embolism 7. mortality rates in ICU, hospital, 30-day, and 90-day. Materials and Methods: This will be a randomized controlled clinical trial recruting 200 patients Inclusion Criteria: 1. age ≥18 2. diagnosed sepsis (Sepsis-3 definition) or septic shock (Septic Shock-3 definition) 3. hemoglobin \<120 g/L for both sexes Exclusion Criteria: 1. bleeding 2. decompensated liver disease 3. inherited microcytic disorders 4. macrocytosis 5. contraindications to pharmacological prophylaxis for venous thromboembolism 6. pregnancy 7. allergy to epoetin alfa and/or iron derisomaltose. 8. ferritin \>800 ng/mL. 9. inability to take consent Study Group: 1. epoetin alfa 50 u/kg IV (days 1, 3, 5, 8, 10, 12) 2. iron derisomaltose 0.2g IV when RET-He \<29.3 pg (days 1, 3, 5, 8, 10, 12) 3. algorithm for red blood cell transfusions Control Group: 1\. algorithm for red blood cell transfusions Laboratory Parameters: Initial: interleukin-6, procalcitonin, C-reactive protein, creatinine, ammonia, blood urea nitrogen, aspartate aminotransferase, alanine aminotransferase, total bilirubin, complete blood count (CBC), reticulocytes (RET), ferritin, iron, transferrin. Serial: CBC and RET (days 1, 3, 5, 8, 10, 12)
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06670963 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Anemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06670963 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06670963 currently recruiting?
Yes, NCT06670963 is actively recruiting participants. Contact the research team at pczempik@sum.edu.pl for enrollment information.
Where is the NCT06670963 trial being conducted?
This trial is being conducted at Katowice, Poland.
Who is sponsoring the NCT06670963 clinical trial?
NCT06670963 is sponsored by Piotr Czempik. The trial plans to enroll 200 participants.