Ilomedin for treatment of septic shock with persistent microperfusion defects

Phase 1

• Conditions: Ilomedin: Cardiology - Angeiology - Vasodilators and anti-ischemic drugs: Severe ischemia: route of injection (Prostaglandin analogs: iloprost); MedDRA version: 20.0Level: PTClassification code 10040070Term: Septic shockSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2018-001709-10-FR
• Lead Sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-07-11
• Last Update Posted: 2 April 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 236

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified