EUCTR2017-004123-67-FR
Active, not recruiting
Phase 1
CHOCMSC StudyEffects of mesenchymal stem cells administration on organ failure during septic shock: Phase II randomized placebo-controlled study - CHOCMSC Study
Centre Hospitalier Régional Universitaire de Nancy0 sites66 target enrollmentJanuary 15, 2018
DrugsVIALEBEX 40 mg/ml
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- septic shock
- Sponsor
- Centre Hospitalier Régional Universitaire de Nancy
- Enrollment
- 66
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\-Male Patient 18 years of age or older, or Woman over 65 years
- •2\-Presence of community\-acquired septic shock for less than 12 hours and associated with at least 2 organ failure other than cardiovascular. The time of septic shock onset is defined as the time of catecholamines introduction
- •3\-Septic shock occurring between Monday 8:00 am and Friday 8:00 am (for reasons of availability of the staff of the UTCT)
- •4\-Prior receipt of written consent (patient / trusted person / family member)
- •5\-Person affiliated to a Social Security
- •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 33
- •F.1\.3 Elderly (\>\=65 years) yes
Exclusion Criteria
- •1\-Shock of non\-septic origin
- •2\-Nosocomial septic shock
- •3\-PaO2 / FiO2 ratio \<100
- •4\-Female under 65 years
- •5\-brain death
- •6\-Moribund patient
- •7\-Initial limatation of care or DNR orders
- •8\-Patient already enrolled in another interventional tria, ongoing or for less than 30 days
Outcomes
Primary Outcomes
Not specified
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