Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:25 PM
Ignite Modification Date:
2025-12-24 @ 7:25 PM
NCT ID:
NCT07214103
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT07214103
Study Brief:
Protocol Section:
NCT07214103