Ilomedin: Cardiology - Angeiology - Vasodilators and anti-ischemic drugs: Severe ischemia: route of injection (Prostaglandin analogs: iloprost) MedDRA version: 20.0 Level: PT Classification code 10040070 Term: Septic shock System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Ilomédine
Product Name: Ilomédine
Product Code: B01AC11
Pharmaceutical Form: Concentrate for solution for infusion
Pharmaceutical form of the placebo: Solution for infusion
Route of admini
Sponsors
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria : *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 in 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 serum lactate level > 2 mmol/L despite standard of care hemodynamic optimization (*see check list). - and persistent hypotension requiring vasopressor treatment to maintain mean arterial pressure > 65 mmHg despite standard of care hemodynamic optimization (*see checklist). - and persistence of peripheral hypoperfusion (mottling score > or = 2 and/or finger skin recoloration time > 3sec, and/or knee skin recoloration time > 4sec) - within 6 to 24 hours after norepinephrine onset 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 236 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Non inclusion criteria : - 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 < 30000 /mm3 - unstable angina. - severe cardiac rhythm disorders since Norepinephrine onset (ventricular fibrillation or tachycardia) - severe hypoxemia (PaO2/FiO2 <100) - lack of social Insurance - persons deprived of liberty
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective: to assess the effect of Ilomedin infusion on organ function in septic shock patients with persistent peripheral hypoperfusion despite macrohemodynamic parameter optimization Secondary objectives: to assess the effect of Ilomedin on: - the risk of death during the first 28 days after randomization - the impact on organ support (i.e. renal replacement therapy, vasopressor treatment, mechanical ventilation) - organ failure during the first 7 days after randomization (evaluated with the SOFA score) - safety of the drug and potential side-effects of Ilomedin ;Secondary Objective: ;Primary end point(s): Primary outcome: Delta SOFA (sequential organ failure assessment) score between randomization and day-7). Secondary outcomes : - mean SOFA score during the first 7 days after randomization - number of survival days outside ICU in the 28 days post randomization - number of ventilation-free survival days in the 28 days post randomization - number of renal replacement therapy-free survival days in the 28 days post randomization - number of vasopressor-free survival days in the 28 days post randomization -mottling score at day 1 after randomizationRésultat primaire: Le score Delta SOFA (évaluation séquentielle des défaillances d'organes) entre la randomisation et le jour 7). Résultats secondaires - score SOFA moyen au cours des 7 premiers jours après la randomisation - nombre de jours de survie en dehors des soins intensifs dans les 28 jours suivant la randomisation - nombre de jours de survie sans ventilation dans les 28 jours suivant la randomisation - nombre de jours de survie sans traitement rénal substitutif dans les 28 jours suivant la randomisation - nombre de jours de survie sans vasopresseur dans les 28 jours suivant la randomisation -mottling score au jour 1 après la randomisation | — |
Countries
France
Contacts
Public ContactDRCI Hôpital St Louis
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
Outcome results
None listed