Efficacy and Safety of Sivelestat Sodium and Dexamethasone in the Treatment of ARDS
NCT ID: NCT06387823
Last Updated: 2024-06-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
300 participants
INTERVENTIONAL
2024-04-15
2025-09-01
Brief Summary
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* Is Sivelestat sodium more effective in the treatment of patients with moderate to severe ARDS compared with placebo?
* Is dexamethasone more effective in the treatment of patients with moderate to severe ARDS compared with placebo? Participants will receive Sivelestat sodium, dexamethasone or placebo. Researchers will compare the efficacy and safety of Sivelestat sodium, dexamethasone and placebo.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Sivelestat sodium
Sivelestat sodium and dexamethasone placebo
Sivelestat sodium
Sevilastat sodium 4.8 mg/kg/d IV continuous infusion for 14 days or ICU length of stay (within 14 days)
Dexamethasone placebo
Dexamethasone placebo 10 mg IV once a day for 5 days or until extubation (within 5 days)
Dexamethasone
Dexamethasone and Sivelestat sodium placebo
Dexamethasone
Dexamethasone 10 mg IV once a day for 5 days or until extubation (within 5 days)
Sivelestat sodium placebo
Sivelestat sodium placebo 4.8 mg/kg/d IV continuous infusion for 14 days or ICU length of stay (within 14 days)
Placebo
Sivelestat sodium placebo and dexamethasone placebo
Sivelestat sodium placebo
Sivelestat sodium placebo 4.8 mg/kg/d IV continuous infusion for 14 days or ICU length of stay (within 14 days)
Dexamethasone placebo
Dexamethasone placebo 10 mg IV once a day for 5 days or until extubation (within 5 days)
Interventions
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Sivelestat sodium
Sevilastat sodium 4.8 mg/kg/d IV continuous infusion for 14 days or ICU length of stay (within 14 days)
Dexamethasone
Dexamethasone 10 mg IV once a day for 5 days or until extubation (within 5 days)
Sivelestat sodium placebo
Sivelestat sodium placebo 4.8 mg/kg/d IV continuous infusion for 14 days or ICU length of stay (within 14 days)
Dexamethasone placebo
Dexamethasone placebo 10 mg IV once a day for 5 days or until extubation (within 5 days)
Eligibility Criteria
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Inclusion Criteria
* Receiving tracheal intubation for mechanical ventilation within 72 hours after an episode of moderate-to-severe ARDS
* ARDS onset to randomized grouping within 72 hours (starting at the time of onset documented in the medical record)
* Patient volunteers to participate in the study and signs an informed consent form
Exclusion Criteria
* brain death
* Advanced cancer or other terminal disease
* History of allergy to Sivelestat Sodium and Dexamethasone
* Severe chronic obstructive pulmonary disease
* History of severe cardiovascular disease, such as heart failure, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled cardiac arrhythmia, uncontrolled hypertension, or history of heart or cerebral infarction within the past six months
* Organ transplant or allogeneic stem cell transplant recipients
* Fatal active fungal infections
* neuromuscular disease that affects voluntary breathing
* Genetic or acquired severe immunodeficiencies such as human immunodeficiency virus (HIV) infection, chronic granulomatous disease, severe combined immunodeficiencies
* Patients and/or legal representatives who sign a Do Not Resuscitate (DNR) advance directive, or who abandon treatment
* Participating in other clinical trials
18 Years
ALL
No
Sponsors
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Peking University
OTHER
Shanghai Huilun Pharmaceutical Co., Ltd.
INDUSTRY
Peking Union Medical College Hospital
OTHER
Responsible Party
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Principal Investigators
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Bin Du, MD
Role: STUDY_CHAIR
Peking Union Medical College
Locations
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Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Luoyang Central Hospital
Luoyang, Henan, China
Yanan University Affiliated Hospital
Yan’an, Shaanxi, China
The Third Hospital of Mianyang
Mianyang, Sichuan, China
Countries
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Central Contacts
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Facility Contacts
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Chunyan Li
Role: primary
Zhiyan Hui
Role: primary
Qionglan Dong
Role: primary
Other Identifiers
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K5321
Identifier Type: -
Identifier Source: org_study_id
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