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Phase IIb Multicenter Randomized Controlled Trial Evaluating the Efficacy of Sivelestat in Patients with Septic Coagulopathy
EU CTIS ID: 2025-523397-16-00
What this study is testing
To evaluate the efficacy of Sivelestat, compared with placebo, in restoring fibrinolysis in septic shock patients with coagulopathy defined by a positive CIS score (≥ 4 points)
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Adults aged 18 to 85
- Patient (male or female) admitted to intensive care with: septic shock as defined by Sepsis-3 criteria [7]: o patient with acute life-threatening organ dysfunction(s) related to suspected or proven infection, requiring vasopressor support to maintain a mean arterial pressure ≥ 65 mmHg, and a serum lactate level > 2 mmol/L in the absence of hypovolaemia o and coagulopathy defined by a SIC score ≥ 4 points [21, 22]
- Randomisation within 12 hours of 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.
- - For women of childbearing age (negative blood pregnancy test)
You likely can't join if
- History of hypersensitivity reaction to Sivelestat (only contraindication to Sivelestat)
- - History of HIT (heparin-induced thrombocytopenia)
- Patient weight > 100 kg
- Severe chronic liver disease (Child-Pugh C)
- Contraindication to the use of unfractionated heparin
- Patient moribund on the day of randomisation
See the full eligibility criteria
- Adults aged 18 to 85
- Patient (male or female) admitted to intensive care with: septic shock as defined by Sepsis-3 criteria [7]: o patient with acute life-threatening organ dysfunction(s) related to suspected or proven infection, requiring vasopressor support to maintain a mean arterial pressure ≥ 65 mmHg, and a serum lactate level > 2 mmol/L in the absence of hypovolaemia o and coagulopathy defined by a SIC score ≥ 4 points [21, 22]
- Randomisation within 12 hours of 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.
- - For women of childbearing age (negative blood pregnancy test)
- History of hypersensitivity reaction to Sivelestat (only contraindication to Sivelestat)
- - History of HIT (heparin-induced thrombocytopenia)
- Patient weight > 100 kg
- Severe chronic liver disease (Child-Pugh C)
- Contraindication to the use of unfractionated heparin
- Patient moribund on the day of randomisation
- Limitation of active therapeutic interventions at the time of study inclusion
- Under legal protection (guardianship, curatorship, or legal safeguard)
- Pregnancy (positive blood pregnancy test) or breastfeeding
- - Participation in another interventional drug clinical trial
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.