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.
Conditions
Brief summary
Safety as assessed by myelotoxicity until day 14 is the primary endpoint.
Detailed description
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.
Interventions
Sponsors
Friedrich-Schiller-Universitaet Jena, Friedrich-Schiller-Universitaet Jena
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety as assessed by myelotoxicity until day 14 is the primary endpoint. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Germany
Outcome results
None listed