Epirubicin for the Treatment of Sepsis & Septic Shock

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 45

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber of participants with myelotoxicity:<br>Neutropenia or thrombocytopenia of grade 3 or 4 (neutrophiles <1,000µL or platelets <50,000/µL) at two consecutive study visits up to day 14 accompanied by neutropenia or thrombocytopenia of grade 2, 3 or 4 (neutrophiles <1,500µL or platelets <75,000/µL) at both study visits and accompanied by an IPF (immature platelet fraction) below 2.5% at one or two of the consecutive study visits.

Secondary Outcome Measures

Name	Time	Method
Survival at day 14, 28 and 90; <br>SOFA score: SOFA (sequential organ failure assessment) on days of assessment, mean total SOFA and SOFA changes over time; Cardiotoxicity:<br>Ejection fraction measured via TTE (trans-thoracic echocardiography); Success rate:<br>Decrease of procalcitonin (PCT) serum concentration by 80% or more of its intra-individual peak value or to 0.5 µg/L or lower within 72 hours after randomization; Adverse events:<br>Overall rate of adverse and severe adverse events. The the frequency of other typical side effects (diarrhea, mucositis, alopecia, nausea and vomiting); Quality of life assesed by the SF-36 questionaire; Fluid balance and urine output; Need for renal replacement therapy; Oxygenation index (paO2/FiO2); Need for respiratory support; Need for catecholamines and inotropes;