Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as • Sivelestat intravenous infusion
Sivelestat infusion · 1 trial · 2 indications
Change in plasma plasminogen levels after 24 hours of treatment with either placebo or Sivelestat.
| Arm | Type | Description |
|---|---|---|
| Active therapy | EXPERIMENTAL | • Sivelestat |
| Placebo therapy | PLACEBO_COMPARATOR | • NaCl |
| Name | Type | Description |
|---|---|---|
| • Sivelestat intravenous infusion | DRUG | * Intervention: Sivelestat 0.20 mg/kg/h via continuous intravenous infusion (IVSE) for 72 hours * Anticoagulation: Unfractionated heparin (UFH) at a minimum dose of 100 IU/24h (or higher if required) |
| NaCl intravenous infusion | DRUG | * Intervention: NaCl 0.9% (normal saline) via continuous intravenous infusion (IVSE) at the same rate as the experimental group for 72 hours * Anticoagulation: Unfractionated heparin (UFH) at a minimum dose of 100 IU/24h (or higher if required) |
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 pr...