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Septic Shock / NaCl intravenous infusion / Coagulopathy · Phase 2 Trial
ClinicalTrials.gov · August 20, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a planned phase IIb multicenter randomized controlled trial of sivelestat versus placebo in septic shock with coagulopathy, registered but not yet recruiting. The study aims to test whether a neutrophil elastase inhibitor can restore fibrinolysis by preventing plasminogen degradation, informed by mechanistic data and prior ARDS mortality data. No results are available; the registry record describes intent and rationale only.
Phase 2, Interventional, Randomized, Parallel, Quadruple masking, Treatment purpose. Septic Shock, Coagulopathy; age from 18 Years; to 85 Years. Intervention: Active therapy. Compared with: Placebo therapy — Placebo Comparator. n = 120. 1 site: France.
Prior meta-analysis (15 studies, 2,050 patients) showed sivelestat reduced ARDS mortality at day 28–30 with RR = 0.81 (95% CI = 0.66–0.98, p = 0.03) Mechanistic rationale: neutrophil elastase bound to NET DNA degrades plasminogen, limiting fibrinolysis in sepsis-induced DIC
Primary outcome is a surrogate (plasma plasminogen at 24 h); hard clinical outcomes (mortality, organ dysfunction) not yet stated. Prior meta-analysis (15 studies, 2,050 patients) showed sivelestat reduced ARDS mortality at day 28–30 with RR = 0.81 (95% CI = 0.66–0.98, p = 0.03)
If results confirm efficacy in restoring fibrinolysis, sivelestat could address an unmet need in sepsis-induced DIC, for which no specific treatment currently exists. Clinicians should await completion and publication of results; this registration does not yet inform practice.
This is a study registration with no results posted; the trial is not yet recruiting and has not been conducted, making it a planning document describing a future phase IIb study.
As stated by the source record.
Quoted from the source exactly as published.
If results confirm efficacy in restoring fibrinolysis, sivelestat could address an unmet need in sepsis-induced DIC, for which no specific treatment currently exists. Clinicians should await completion and publication of results; this registration does not yet inform practice.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
Registry record from ClinicalTrials.gov (NCT07214103). This is a study registration, not published results. Lead sponsor: University Hospital, Strasbourg, France. Recruitment status: NOT_YET_RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 120 participants (ESTIMATED). Conditions: Septic Shock, Coagulopathy. Interventions: DRUG: • Sivelestat intravenous infusion; DRUG: NaCl intravenous infusion. Primary outcome measures: Plasma plasminogen levels , 24 hours. 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 from excessive systemic activation of coagulation and impaired fibrinolysis, leading to the development of disseminated microthromboses. We have recently demonstrated: 1) the contribution of NETs to the hypercoagulability observed in DIC, and 2) the role of neutrophil elastase-bound to NET DNA-in degrading plasminogen, a key factor limiting fibrinolysis and thus preventing the lysis of microthrombi in DIC. Sivelestat is a neutrophil elastase inhibitor used in Japan for the treatment of acute respiratory distress syndrome (ARDS). It has the potential to inhibit: 1) neutrophil activation and the release of inflammatory mediators, and 2) plasminogen degradation, which drives fibrinolytic failure. A recent meta-analysis including 2,050 patients across 15 studies showed that Sivelestat reduced ARDS patient mortality at day 28-30 (RR = 0.81, 95% CI = 0.66-0.98, p = 0.03), decreased mechanical ventilation duration and ICU length of stay, and improved oxygenation. We propose to conduct a multicenter, double-blind, placebo-controlled phase IIb trial evaluating the efficacy of Sivelestat in restoring fibrinolysis in patients with septic shock complicated by coagulopathy, defined by a positive SIC score (≥ 4 points).
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.