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Clinical Trials/EUCTR2017-004123-67-FR
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

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.

Registry
who.int
Start Date
January 15, 2018
End Date
TBD
Last Updated
5 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Centre Hospitalier Régional Universitaire de Nancy

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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