NCT07214103View on ClinicalTrials.gov

Phase IIb Multicenter Randomized Controlled Trial Evaluating the Efficacy of Sivelestat in Patients With Septic Coagulopathy

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

March 1, 2026

Primary Completion Date

December 31, 2032

Study Completion Date

December 31, 2032

Conditions
Septic ShockCoagulopathy
Interventions
DRUG

• Sivelestat intravenous infusion

"* 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)"

DRUG

NaCl intravenous infusion

"* 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)"

Trial Locations (1)

67091

Hôpitaux Universitaires de Strasbourg, Strasbourg

All Listed Sponsors
lead

University Hospital, Strasbourg, France

OTHER