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| Name | Class |
|---|---|
| Peking University | OTHER |
| Shanghai Huilun Pharmaceutical Co., Ltd. | INDUSTRY |
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The goal of this clinical trial is to evaluate the efficacy and safety of Sivelestat sodium and dexamethasone in the treatment of patients with moderate to severe ARDS. The main questions it aims to answer are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sivelestat sodium | Active Comparator | Sivelestat sodium and dexamethasone placebo |
|
| Dexamethasone | Active Comparator | Dexamethasone and Sivelestat sodium placebo |
|
| Placebo | Placebo Comparator | Sivelestat sodium placebo and dexamethasone placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sivelestat sodium | Drug | Sevilastat sodium 4.8 mg/kg/d IV continuous infusion for 14 days or ICU length of stay (within 14 days) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 28-day ventilator-free days | ventilator-free days within 28 days | 28 days after randomization |
| Informed consent rate | The rate of informed consent | 90 days after randomization |
| Recruitment rate | The rate of recruitment | 90 days after randomization |
| Recruitment compliance rate | The rate of recruitment compliance | 90-day after randomization |
| Protocol adherence rate | The rate of protocol adherence | 90 days after randomization |
| Completion of follow-up visits | The rate of completion of follow-up visits | 90 days after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| 28-day mortality | 28-day mortality | 28 days after randomization |
| 90-day mortality | 90-day mortality | 90 days after randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yan Chen | Contact | +8613538700762 | libby0212@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Bin Du, MD | Peking Union Medical College | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Recruiting | Beijing | Beijing Municipality | 100730 | China |
IPD will be shared upon proper requirement.
After publication of the study.
Upon proper requirement sent to the primary investigator.
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| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| Dexamethasone | Drug | Dexamethasone 10 mg IV once a day for 5 days or until extubation (within 5 days) |
|
| Sivelestat sodium placebo | Drug | Sivelestat sodium placebo 4.8 mg/kg/d IV continuous infusion for 14 days or ICU length of stay (within 14 days) |
|
| Dexamethasone placebo | Drug | Dexamethasone placebo 10 mg IV once a day for 5 days or until extubation (within 5 days) |
|
| 28-day length of stay | The time interval between randomization and transfer out of ICU. Recorded as 28 days for those who were not transferred out of the ICU 28 days after randomization or those who died during ICU stay | 28 days after randomization |
| 28-day organ support free day | Days without intensive care-based respiratory or cardiovascular organ support within 28 days of randomization. | 28 days after randomization |
| Sequential organ failure assessment (SOFA) | Sequential organ failure assessment (SOFA) score evaluation within 14 days. The minimum value is 0 and maximum value is 24, and higher scores mean a worse outcome. | 14 days after randomization |
| Murray's acute lung injury score | Murray's acute lung injury score within 14 days after randomization. The minimum value is 0 and maximum value is 4, and higher scores mean a worse outcome. | 14 days after randomization |
| C-reactive protein (CRP) | C-reactive protein (CRP) | 14 days after randomization |
| Interleukin-6 (IL-6) | Interleukin-6 (IL-6) | 14 days after randomization |
| Interleukin-8 (IL-8) | Interleukin-8 (IL-8) | 14 days after randomization |
| Procalcitonin (PCT) | Procalcitonin (PCT) | 14 days after randomization |
| Neutrophil-to-lymphocyte Ratio (NLR) | Neutrophil-to-lymphocyte Ratio (NLR) | 14 days after randomization |
| Neutrophil elastase | Neutrophil elastase level of blood and alveolar fluid | 14 days after randomization |
| New-onset infection rate | Rate of new-onset infection | 28 days after randomization |
| Re-intubation rate | Rate of unplanned re-intubation | 28 days after randomization |
| Adverse event | Pneumatic trauma (pneumothorax, mediastinal emphysema, subcutaneous emphysema, or imaging findings), infection, sepsis, respiratory acidosis, severe acidosis (pH < 7.10), refractory hypoxemia (PaO2 < 55 mmHg), severe hypotension (mean arterial pressure < 65 mmHg), new-onset arrhythmia (new-onset atrial fibrillation or supraventricular tachycardia), cardiac arrest, and all serious adverse events | 28 days after randomization |
| Luoyang Central Hospital | Not yet recruiting | Luoyang | Henan | China |
|
| Yanan University Affiliated Hospital | Recruiting | Yan’an | Shaanxi | China |
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| The Third Hospital of Mianyang | Not yet recruiting | Mianyang | Sichuan | China |
|
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |