An interventional study of Sivelestat sodium and Dexamethasone in Acute Respiratory Distress Syndrome, sponsored by Peking Union Medical College Hospital. Recruiting at 4 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-04.
Sponsored by Peking Union Medical College Hospital · Not applicable, Interventional, and Treatment
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:
1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.
This study's planned enrollment of 300 is above the median of 60 across 961 interventional studies indexed under Respiratory Distress Syndrome.
Browse Respiratory Distress Syndrome studies →Peking Union Medical College Hospital is the lead sponsor of 1,115 studies on the registry; 463 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Sivelestat sodium and dexamethasone placebo
Drug: Sivelestat sodium · Drug: Dexamethasone placebo
Dexamethasone and Sivelestat sodium placebo
Drug: Dexamethasone · Drug: Sivelestat sodium placebo
Sivelestat sodium placebo and dexamethasone placebo
Drug: Sivelestat sodium placebo · Drug: Dexamethasone placebo
Sevilastat sodium 4.8 mg/kg/d IV continuous infusion for 14 days or ICU length of stay (within 14 days)
Dexamethasone 10 mg IV once a day for 5 days or until extubation (within 5 days)
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)
28-day ventilator-free days
ventilator-free days within 28 days
Time frame: 28 days after randomization
Informed consent rate
The rate of informed consent
Time frame: 90 days after randomization
Recruitment rate
The rate of recruitment
Time frame: 90 days after randomization
Recruitment compliance rate
The rate of recruitment compliance
Time frame: 90-day after randomization
Protocol adherence rate
The rate of protocol adherence
Time frame: 90 days after randomization
Completion of follow-up visits
The rate of completion of follow-up visits
Time frame: 90 days after randomization
28-day mortality
28-day mortality
Time frame: 28 days after randomization
90-day mortality
90-day mortality
Time frame: 90 days after randomization
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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 14 days after randomization
C-reactive protein (CRP)
C-reactive protein (CRP)
Time frame: 14 days after randomization
Interleukin-6 (IL-6)
Interleukin-6 (IL-6)
Time frame: 14 days after randomization
Interleukin-8 (IL-8)
Interleukin-8 (IL-8)
Time frame: 14 days after randomization
Procalcitonin (PCT)
Procalcitonin (PCT)
Time frame: 14 days after randomization
Neutrophil-to-lymphocyte Ratio (NLR)
Neutrophil-to-lymphocyte Ratio (NLR)
Time frame: 14 days after randomization
Neutrophil elastase
Neutrophil elastase level of blood and alveolar fluid
Time frame: 14 days after randomization
New-onset infection rate
Rate of new-onset infection
Time frame: 28 days after randomization
Re-intubation rate
Rate of unplanned re-intubation
Time frame: 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
Time frame: 28 days after randomization
Plan to share: Yes — IPD will be shared upon proper requirement.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
No publications or documents are linked to this record.
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