Septic Shock
Conditions
Brief summary
The main purpose at the early phase of septic shock on the evolution of organ failure judged by the SOFA (Sepsis Organ Failure Assessment score) score on Day 7 (or the day of death or the day of discharge from the intensive care unit if before Day 7) compared to SOFA score observed in patients in the control group. The secondary purpose is to assess the role of heterologous mesenchymal stem cells on the occurrence and duration of failure of each organ and on the mortality at day 28 and day 90. The safety of administration will be also assessed.
Detailed description
Patients hospitalized in recovery unit and having a very severe septic shock with community origin (≥ 2 organ failures other than hemodynamic) since less than 12 hours, will receive 10\^6/kg heterologous mesenchymal stem cells in 250 ml albumin 4%, infused for 30 minutes in central venous line or 250 ml albumin 4% alone.
Interventions
BIOLOGICALInjection of albumin alone
Injection of albumin alone
BIOLOGICALInjection of mesenchymal stem cells
Injection of mesenchymal stem cells
Sponsors
Central Hospital, Nancy, France
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Septic shock of community origin since less than 12 hours. The onset time of septic shock is the time of catecholamine introduction( adrenaline, noradrenaline, or dopamine \> 8μg/kg/min) * At least 2 organ failure other than hemodynamic * Occurrence between Monday 8am and Friday 8am (for availability reasons of staff) * Signature of informed consent (patient/close relative or reliable person) * Affiliation to social security plan
Exclusion criteria
* Non-septic shock * Nosocomial septic shock * PaO2/FiO2 \<100 * Pregnant or breast-feeding woman * Brain death * Dying person * Therapeutic limitations * Participation to another current interventional clinical trial or since less than 30 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SOFA score | Day 7 (or death day or day of recovery unit exit if before day 7) | To assess the efficacy of a recovery treatment |
Secondary
| Measure | Time frame |
|---|---|
| Number of living days without mechanical ventilation | Day 28 |
| Number of living days without dialysis | Day 28 |
| Number of living days without catecholamines | Day 28 |
| Mortality, across all causes | Day 28 |
| Administration safety (i.e. side effects) | up to 90 days |
| Duration of residence time in recovery unit | Day of exit from recovery unit, up to 90 days |
Countries
France
Contacts
Primary ContactSébastien GIBOT
Backup ContactDaniele BENSOUSSAN
Outcome results
None listed