Can a japanese ARDS drug fix deadly clots in septic shock?

NCT ID NCT07214103

Disease control Sponsor: University Hospital, Strasbourg, France Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Aug 21, 2026 · Updated 4 times

Summary

This study tests whether sivelestat, a drug used in Japan for lung injury, can help restore the body's ability to break down harmful blood clots in people with septic shock. About 120 adults with septic shock and early blood clotting problems will receive either sivelestat or a placebo for 72 hours. The main goal is to see if sivelestat raises plasminogen levels, a key protein for dissolving clots.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Sivelestat (a drug that blocks neutrophil elastase, given as a continuous IV infusion for 72 hours)
What this could lead to: If it works, this could point toward a new treatment to improve blood clot breakdown in septic shock patients, potentially reducing organ damage and death.
What could go wrong: This is an early Phase IIb trial with only 120 patients, so results may not be conclusive. The drug has not been proven for this specific condition, and risks like bleeding or allergic reactions are possible.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2027

An estimate. Start dates often move.

Expected to finish

Dec 2032

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

blood coagulation disease disseminated intravascular coagulation toxic shock syndrome vascular hemostatic disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Coagulopathy Septic shock

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

1 site. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

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Can a japanese ARDS drug fix deadly clots in septic shock?

What the study statuses mean