Status:
NOT_YET_RECRUITING
Phase IIb Multicenter Randomized Controlled Trial Evaluating the Efficacy of Sivelestat in Patients With Septic Coagulopathy
Lead Sponsor:
University Hospital, Strasbourg, France
Conditions:
Septic Shock
Coagulopathy
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief Summary
Sepsis-induced disseminated intravascular coagulation (DIC) is a severe complication occurring in one-third of patients with septic shock, for which no specific treatment currently exists. It results ...
Eligibility Criteria
Inclusion
- Adults aged 18 to 85 years
- Patient (male or female) admitted to the ICU with:
- Septic shock defined by Sepsis-3 criteria: acute, life-threatening organ dysfunction related to a suspected or confirmed infection, requiring vasopressor support to maintain a mean arterial pressure ≥ 65 mmHg and a serum lactate level \> 2 mmol/L despite adequate fluid resuscitation.
- Coagulopathy defined by a SIC score ≥ 4 points.
- Randomization within 12 hours after the diagnosis of coagulopathy (positive SIC score).
- Patient affiliated with a national health insurance system.
- Written informed consent: freely given, dated, and signed.
- By the patient
- Or by a legal representative if the patient is unable to provide consent.
- Or through an emergency inclusion procedure if the patient is unable to consent and no family member is available
Exclusion
- History of hypersensitivity reaction to Sivelestat (the only contraindication for Sivelestat)
- Patient weight \> 100 kg
- Severe chronic liver disease (Child-Pugh C)
- Contraindication to the use of unfractionated heparin
- Moribund patient at the time of randomization
- Limitation of active therapeutic interventions at the time of study inclusion
- Under legal protection (guardianship, curatorship, or legal safeguard)
- Pregnancy or breastfeeding
- Participation in another interventional drug clinical trial
Key Trial Info
Start Date :
March 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2032
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT07214103
Start Date
March 1 2026
End Date
December 31 2032
Last Update
October 9 2025
Active Locations (1)
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1
Hôpitaux Universitaires de Strasbourg
Strasbourg, France, France, 67091