Informations générales (source: ClinicalTrials.gov)
Effects of Mesenchymal Stem Cells Administration on Organ Failure During Septic Shock: Phase II Randomized Comparator-controlled Study (CHOCMSC)
Interventional
N/A
Central Hospital, Nancy, France (Voir sur ClinicalTrials)
décembre 2019
novembre 2022
29 juin 2024
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.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Hôpital Hautepierre, Service de réanimation médicale - Strasbourg - France | Contact (sur clinicalTrials) | ||||
| Service de Réanimation Médicale, Hôpital Bocage - Dijon - France | Contact (sur clinicalTrials) | ||||
| Service de Réanimation Médicale, Hôpital Central - Nancy - France | Contact (sur clinicalTrials) | ||||
| UTCT, Hôpital Brabois - Vandoeuvre-les-Nancy - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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
- 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
- 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