Acute Respiratory Distress Syndrome
Conditions
Brief summary
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: * 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.
Interventions
Sevilastat sodium 4.8 mg/kg/d IV continuous infusion for 14 days or ICU length of stay (within 14 days)
DRUGDexamethasone
Dexamethasone 10 mg IV once a day for 5 days or until extubation (within 5 days)
DRUGSivelestat 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 10 mg IV once a day for 5 days or until extubation (within 5 days)
Sponsors
Peking University
Shanghai Huilun Pharmaceutical Co., Ltd.
Peking Union Medical College Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with moderate-to-severe ARDS in the acute exacerbation phase who meet the diagnostic criteria for moderate-to-severe ARDS * 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
* Pregnancy or breastfeeding * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 28-day ventilator-free days | 28 days after randomization | ventilator-free days within 28 days |
| Informed consent rate | 90 days after randomization | The rate of informed consent |
| Recruitment rate | 90 days after randomization | The rate of recruitment |
| Recruitment compliance rate | 90-day after randomization | The rate of recruitment compliance |
| Protocol adherence rate | 90 days after randomization | The rate of protocol adherence |
| Completion of follow-up visits | 90 days after randomization | The rate of completion of follow-up visits |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| C-reactive protein (CRP) | 14 days after randomization | C-reactive protein (CRP) |
| Interleukin-6 (IL-6) | 14 days after randomization | Interleukin-6 (IL-6) |
| Interleukin-8 (IL-8) | 14 days after randomization | Interleukin-8 (IL-8) |
| Procalcitonin (PCT) | 14 days after randomization | Procalcitonin (PCT) |
| 28-day mortality | 28 days after randomization | 28-day mortality |
| Neutrophil elastase | 14 days after randomization | Neutrophil elastase level of blood and alveolar fluid |
| New-onset infection rate | 28 days after randomization | Rate of new-onset infection |
| Re-intubation rate | 28 days after randomization | Rate of unplanned re-intubation |
| Adverse event | 28 days after randomization | 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 |
| Neutrophil-to-lymphocyte Ratio (NLR) | 14 days after randomization | Neutrophil-to-lymphocyte Ratio (NLR) |
| 90-day mortality | 90 days after randomization | 90-day mortality |
| 28-day length of stay | 28 days after randomization | 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-day organ support free day | 28 days after randomization | Days without intensive care-based respiratory or cardiovascular organ support within 28 days of randomization. |
| Sequential organ failure assessment (SOFA) | 14 days after randomization | 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. |
| Murray's acute lung injury score | 14 days after randomization | 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. |
Countries
China
Contacts
Primary ContactYan Chen
Outcome results
None listed