septisch shock septic shock and severe blood poisoning
Conditions
Interventions
Infusion: 60 or 90 x 106 MSCs, dependent of weight, supplementary to the
standard care in the experimental arm and only standard care in the control arm.
Frequnecy: daily for 3 days (first dose with
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients between 18 and 75 years, fulfilling the criteria for pneumonia septic shock. ;(see chapter 4.2 and Appendix B of the research protocol)
Exclusion criteria
Exclusion criteria: Moribund and where death is imminent, pregnancy, inflammatory diseases from any other origin then sepsis, chronic pulmonary or kidney disorders, active malignancies, single organ or other stem cell transplantations and participation in other clinical intervention studies. ;(see section 4.3 of the research protocol)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary parameters: the dose of norepinephrine and the systolic blood pressure at specified time points. The primary outcome measure: shock-reversal time. Definition: the reversal of shock is defined as the maintenance of systolic blood pressure of at least 90 mmHg without vasopressor support for at least 24 hours as described earlier. (See section 8.1 of the research protocol) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints: 1. treatment related toxicity 2. systemic immune cell response 3. disease severity and outcome (See for detailed description section 8.2 and 8.3 of the research protocol) | — |
Countries
Netherlands
Outcome results
None listed