Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-26 @ 10:57 AM
NCT ID:
NCT05033808
Eligibility Criteria:
Inclusion Criteria:
* admitted to the ICU with sepsis or septic shock, diagnosed within the previous 24 hours
Exclusion Criteria:
* Leukopenia/Neutropenia/Thrombocytopenia-prior or upon inclusion (Leucocyte Count \<4000/μL; Neutrophile/ platelets Count below Lower Limit of Normal).
* Weight \>135 kg/BMI \>45.
* Active neoplasia.
* History of chemotherapy.
* Hypersensitivity to epirubicin
* History of bone marrow or solid organ transplantation.
* Immunosuppressive therapy.
* Acute severe infection within 4 weeks prior to admission (Hospitalization or admission to higher level clinical care facility for infection).
* Chronic infection.
* Cardiomyopathy with a documented ejection fraction \<30% or AICD (automatic internal cardioverter defibrillator) implantation.
* Acute liver failure following the European Association for the Study of the Liver definition as International Normalized Ratio (INR) \>1.5 and elevation of transaminases \> 3 times of the upper normal limit (2).
* Pregnancy during all trimesters/breast-feeding.
* Chronic mechanical ventilation dependency.
* Cystic fibrosis.
* Concomitant medication with Verapamil or Cimetidine.
* Prior enrollment in this study.
* Participation in another clinical intervention trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05033808
Study Brief:
Protocol Section:
NCT05033808