Epirubicin for the Treatment of Sepsis & Septic Shock - EPOS-1

Friedrich-Schiller-Universität Jena0 个研究点目标入组 45 人开始时间: 2022年2月24日最近更新: 2024年8月19日

适应症

试验速览

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•Patients >18 years with sepsis or septic shock, currently hospitalized at the ICU or IMC regardless where the sepsis was first diagnosed.
•Sepsis diagnosis within 48 hours prior to screening regardless of site of infection.

•Leukopenia/Neutropenia/Thrombocytopenia-prior or upon inclusion (Leukocyte Count <4,000/µL; Neutrophil/Thrombocyte Count below Lower Limit of Normal)
•Weight >135 kg/BMI >45.
•Ongoing or 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 for an infection or in case of hospital acquired infection transfer to a higher level of care due to the infection)
•Chronic infection.
•Cardiomyopathy with a documented ejection fraction <30% or ICD 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
•Pregnancy during all trimester/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.

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