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
PHASE4
324 participants
INTERVENTIONAL
2022-04-18
2026-03-30
Brief Summary
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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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Saline
Saline
50ml normal saline was continuously pumped in the dark for 24h. Applied for 5 consecutive days
Sivelestat Sodium
Sivelestat sodium
4.8mg/kg sivelestat sodium was given in 50ml normal saline, and was continuously pumped in the dark for 24h, equivalent to 0.2mg/kg/h.Applied for 5 consecutive days
Interventions
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Sivelestat sodium
4.8mg/kg sivelestat sodium was given in 50ml normal saline, and was continuously pumped in the dark for 24h, equivalent to 0.2mg/kg/h.Applied for 5 consecutive days
Saline
50ml normal saline was continuously pumped in the dark for 24h. Applied for 5 consecutive days
Eligibility Criteria
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Inclusion Criteria
2. Patients fulfilled the Berlin diagnostic criteria of acute respiratory distress syndrome, with a arterial oxygen partial pressure (PaO2) to fraction of inspired oxygen (FiO2) between 150 mmHg and 300 mmHg.
3. Signed written informed consent has been obtained
Exclusion Criteria
2. Single cardiogenic pulmonary edema
3. Apach2 score ≥21 points
4. Complicated with end-stage disease, or poor prognosis judged by the clinical doctor in charge
5. ARDS course\>3 days
6. Agranulocytosis or receiving immunosuppressive agents or high doses of corticosteroids (methylprednisolone\>40mg/day)
7. Pregnancy or breastfeeding
8. Participated in this study
9. Do not agree to participate in this experiment
18 Years
75 Years
ALL
No
Sponsors
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Sichuan Provincial People's Hospital
OTHER
Responsible Party
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He Hongli
Principal Investigator
Principal Investigators
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Xiaobo Huang, MD
Role: PRINCIPAL_INVESTIGATOR
Sichuan Academy of Medical Sciences
Locations
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Sichuan provincial people's hospital
Chengdu, Sichuan Privince, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SichuanPPHospital
Identifier Type: -
Identifier Source: org_study_id
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