Effects of mesenchymal stem cells administration on organ failure during septic shock: Phase II randomized comprator-controlled study CHOC-MSC

Conditions

La population concernée est celle des patients hospitalisés en réanimation présentant un choc septique d’origine communautaire très sévère (≥ 2 défaillances d’organes autres qu’hémodynamiques) depuis moins de 12 heures.

Brief summary

The primary endpoint is the SOFA score (clinico-biological severity score ranging from 0 to 24 points) at D7 (or the day of death or discharge from intensive care if before D7) compared with that observed in patients in the control group.

Detailed description

For objective 1: Time to SOFA < 3 (in days). Start date = date of arrival in the intensive care unit, end date = D7., For the 2nd objective: i) Number of days living without respiratory assistance at D28, ii) Number of days living without catecholamines at D28, iii) Number of days living without extra-renal purification at D28, iv) Length of stay in intensive care and in hospital,, For the 3rd objective: i) mortality at D28, ii) mortality at D90, For the 4th objective i) Transient fall in PaO2/FiO2 ratio (or arterial desaturation >5%) within 2 hours of MSC administration ii) Transient rise in mean pulmonary arterial pressure (>5 mHg) within 2 hours of MSC administration iii) Shivering, hyperthermia within 2 hours of MSC administration iv) occurrence of pulmonary embolism within 2 hours of MSC administration v) occurrence of adverse events up to 90 days after MSC injection.

Related papers

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Interventions

DRUGVIALEBEX 40 g/L

DRUGsolution pour perfusion

DRUGMesenchymal Stem Cells (MSCs)

DRUGSODIUM CHLORIDE

DRUGALBUMIN

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the SOFA score (clinico-biological severity score ranging from 0 to 24 points) at D7 (or the day of death or discharge from intensive care if before D7) compared with that observed in patients in the control group.	—

Secondary

Measure	Time frame
For objective 1: Time to SOFA < 3 (in days). Start date = date of arrival in the intensive care unit, end date = D7., For the 2nd objective: i) Number of days living without respiratory assistance at D28, ii) Number of days living without catecholamines at D28, iii) Number of days living without extra-renal purification at D28, iv) Length of stay in intensive care and in hospital,, For the 3rd objective: i) mortality at D28, ii) mortality at D90, For the 4th objective i) Transient fall in PaO2/FiO2 ratio (or arterial desaturation >5%) within 2 hours of MSC administration ii) Transient rise in mean pulmonary arterial pressure (>5 mHg) within 2 hours of MSC administration iii) Shivering, hyperthermia within 2 hours of MSC administration iv) occurrence of pulmonary embolism within 2 hours of MSC administration v) occurrence of adverse events up to 90 days after MSC injection.	—

Measure

Time frame

For objective 1: Time to SOFA < 3 (in days). Start date = date of arrival in the intensive care unit, end date = D7., For the 2nd objective: i) Number of days living without respiratory assistance at D28, ii) Number of days living without catecholamines at D28, iii) Number of days living without extra-renal purification at D28, iv) Length of stay in intensive care and in hospital,, For the 3rd objective: i) mortality at D28, ii) mortality at D90, For the 4th objective i) Transient fall in PaO2/FiO2 ratio (or arterial desaturation >5%) within 2 hours of MSC administration ii) Transient rise in mean pulmonary arterial pressure (>5 mHg) within 2 hours of MSC administration iii) Shivering, hyperthermia within 2 hours of MSC administration iv) occurrence of pulmonary embolism within 2 hours of MSC administration v) occurrence of adverse events up to 90 days after MSC injection.

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Countries

France

Outcome results

None listed