Status:
COMPLETED
ILOPROST in Septic Shock With Persistent Microperfusion Defects (I-MICRO)
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Septic Shock Hyperdynamic
Eligibility:
All Genders
18-99 years
Phase:
PHASE3
Brief Summary
Septic shock remains a major cause of death in critically ill patients. Alterations in microcirculation have long been proposed as a key pathophysiological factor of organ dysfunction and death in sep...
Detailed Description
In the 32 participating centers: patients with septic shock and persistent peripheral hypoperfusion despite hemodynamic optimization (skin mottling and/or finger skin recoloration time \> 3sec, and/or...
Eligibility Criteria
Inclusion
- Patients over 18 years of age
- Signed informed consent or inclusion under the emergency provisions of the law (Article L1122 -1-3 of the PHC / modified by Order n°2016-800 of June 16 2016 - art. 2).
- Patients with septic shock defined by the third international definition:
- suspected or proven infection,
- and organ dysfunction defined by an acute change in total SOFA score \>or=2
- and persistent hypotension requiring vasopressor treatment to maintain mean arterial pressure \> 65 mmHg despite standard of care hemodynamic optimization
- and serum lactate level \> 2 mmol/L despite standard of care hemodynamic optimization
- and persistence of peripheral hypoperfusion (skin mottling and/or finger skin recoloration time \> 3sec, and/or knee skin recoloration time \> 4sec) despite standard of care hemodynamic optimization
- Within 6 to 24 hours after norepinephrine onset
Exclusion
- Refusal to participate in the study
- Pregnancy, breastfeeding
- Hypersensitivity to Ilomedin or to any of the excipients.
- Conditions where the hemorrhagic risk may be increased due to the effects of Ilomedin on platelets (i.e., evolving hemorrhage, trauma, intracranial hemorrhage, active gastric ulcer).
- Platelet count \< 10000 /mm3
- unstable angina.
- severe cardiac rhythm disorders since Norepinephrine onset
- severe hypoxemia (PaO2/FiO2 \<100)
- myocardial infarction in the last 6 months
- lack of Social Insurance
- persons deprived of liberty
- persons of a protective measure
Key Trial Info
Start Date :
July 3 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 18 2024
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT03788837
Start Date
July 3 2019
End Date
January 18 2024
Last Update
July 3 2024
Active Locations (1)
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1
Departement of Anesthesiology, Critical Care and Burn Unit; Saint-Louis hospital
Paris, France, 75010