Efficacy and Safety of Sivelestat Sodium and Dexamethasone in the Treatment of ARDS
- Conditions
- Acute Respiratory Distress Syndrome
- Interventions
- Registration Number
- NCT06387823
- Lead Sponsor
- Peking Union Medical College Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 300
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sivelestat sodium Dexamethasone placebo Sivelestat sodium and dexamethasone placebo Placebo Dexamethasone placebo Sivelestat sodium placebo and dexamethasone placebo Sivelestat sodium Sivelestat sodium Sivelestat sodium and dexamethasone placebo Dexamethasone Sivelestat sodium placebo Dexamethasone and Sivelestat sodium placebo Placebo Sivelestat sodium placebo Sivelestat sodium placebo and dexamethasone placebo Dexamethasone Dexamethasone Dexamethasone and Sivelestat sodium placebo
- Primary Outcome Measures
Name Time Method Recruitment rate 90 days after randomization The rate of recruitment
Recruitment compliance rate 90-day after randomization The rate of recruitment compliance
Informed consent rate 90 days after randomization The rate of informed consent
Protocol adherence rate 90 days after randomization The rate of protocol adherence
28-day ventilator-free days 28 days after randomization ventilator-free days within 28 days
Completion of follow-up visits 90 days after randomization The rate of completion of follow-up visits
- Secondary Outcome Measures
Name Time Method Interleukin-6 (IL-6) 14 days after randomization Interleukin-6 (IL-6)
90-day mortality 90 days after randomization 90-day mortality
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.
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.
Interleukin-8 (IL-8) 14 days after randomization Interleukin-8 (IL-8)
28-day mortality 28 days after randomization 28-day mortality
C-reactive protein (CRP) 14 days after randomization C-reactive protein (CRP)
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
Procalcitonin (PCT) 14 days after randomization Procalcitonin (PCT)
Neutrophil-to-lymphocyte Ratio (NLR) 14 days after randomization Neutrophil-to-lymphocyte Ratio (NLR)
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
Trial Locations
- Locations (4)
Luoyang Central Hospital
🇨🇳Luoyang, Henan, China
Peking Union Medical College Hospital
🇨🇳Beijing, Beijing, China
Yanan University Affiliated Hospital
🇨🇳Yanan, Shaanxi, China
The Third Hospital of Mianyang
🇨🇳Mianyang, Sichuan, China