Epirubicin for the Treatment of Sepsis & Septic Shock

• Status: Not yet recruiting
• Trial end date: 2023-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The study will assess the safety of low doses of epirubicin in sepsis patients. Therefore the study will look for side effects in patients treated with low dose epirubicin compared to control patients.

In animals, low dose epirubicin has been shown to induce tolerance to infection and increase survival in septic mice.

The study will also look for positive effects on organ function in humans. The investigators hypothesize that low-dose epirubicin can be used therapeutically to improve the disease course and lessen mortality of patients with sepsis. In a first step, the investigators aim at proving that low-dose epirubicin can safely be administered to sepsis patients and will perform a dose-escalation multi-center trial.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jena University Hospital
• Collaborators: Ruhr University of Bochum; University Medicine Greifswald
• Treatments: Epirubicin

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.