Patients with sepsis or septic shock, currently hospitalized at the Intensive Care Unit (ICU) or Intermediate Care (IMC) regardless where the sepsis was first diagnosed. MedDRA version: 20.0 Level: PT Classification code 10040047 Term: Sepsis System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Epirubicin 50 mg HEXAL® Injektionslösung
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Epirubicinhydrochlorid
CAS Number: 56390-09-1
Current Sponsor code:
Sponsors
Friedrich Schiller University
Eligibility
Sex/Gender
All
Inclusion criteria
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. Written informed consent of subject or its authorized representative or legal representative or confirmation of the urgency of participation in the clinical trial and the possible benefit to the subject by an independent consultant or the implementation of other established procedures according to the local regulations of the contributing center to include subjects who are unable to provide informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 35
Exclusion criteria
Exclusion criteria: • Leukopenia/Neutropenia/Thrombocytopenia-prior or upon inclusion (Leukocyte Count 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 or admission to higher level clinical care facility for infection). • Chronic infection. • Cardiomyopathy with a documented ejection fraction 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess safety of low-dose epirubicin as an adjunctive therapy for patients with sepsis and septic shock;Secondary Objective: To assess efficacy of low-dose epirubicin as an adjunctive therapy for patients with sepsis and septic shock;Primary end point(s): Safety as assessed by myelotoxicity until day 14.;Timepoint(s) of evaluation of this end point: continuously, especially at day 0 (15, 60, 120 minutes and 3, 6, 12, 24 Hours after drug Administration), day 1, day 2, day 3, day 5, day 7, day 10, day 12 and day 14. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Degree of organ dysfunction measured by SOFA Score. Occurrence of Adverse events. Occurrence of Cardiotoxicity. Survival at day 14, 28 and 90. SOFA “Success” rate defined as a 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;Timepoint(s) of evaluation of this end point: continuously, especially at day 0 (15, 60, 120 minutes and 3, 6, 12, 24 Hours after drug Administration), day 1, day 2, day 3, day 5, day 7, day 10, day 12, day 14, day 28 and day 90. | — |
Countries
Germany
Contacts
Public ContactProject Manager
Jena University Hospital, Center for Clinical Studies
Outcome results
None listed