Efficacy and Safety of Sivelestat Sodium and Dexamethasone in the Treatment of ARDS

Acute Respiratory Distress Syndrome Clinical Trial

— STAR  

Official title:

Efficacy and Safety of Sivelestat Sodium and Dexamethasone in the Treatment of ARDS: a Pilot Study of a Prospective, Multicenter, Double-blind, Double-mock Randomized Controlled Clinical Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06387823
• Other study ID #: K5321
• Status: Recruiting
• Phase: N/A
• Start date: April 15, 2024
• Est. completion date: September 1, 2025

Study information

• Verified date: June 2024
• Source: Peking Union Medical College Hospital
• Contact: Yan Chen
• Phone: +8613538700762
• Email: libby0212[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: September 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn

Intervention

Drug:
• Sivelestat sodium
Sevilastat sodium 4.8 mg/kg/d IV continuous infusion for 14 days or ICU length of stay (within 14 days)
• Dexamethasone
Dexamethasone 10 mg IV once a day for 5 days or until extubation (within 5 days)
• Sivelestat 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
Dexamethasone placebo 10 mg IV once a day for 5 days or until extubation (within 5 days)

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing
China	Luoyang Central Hospital	Luoyang	Henan
China	The Third Hospital of Mianyang	Mianyang	Sichuan
China	Yanan University Affiliated Hospital	Yanan	Shaanxi

Sponsors (3)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital	Peking University, Shanghai Huilun Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	28-day ventilator-free days	ventilator-free days within 28 days	28 days after randomization
Primary	Informed consent rate	The rate of informed consent	90 days after randomization
Primary	Recruitment rate	The rate of recruitment	90 days after randomization
Primary	Recruitment compliance rate	The rate of recruitment compliance	90-day after randomization
Primary	Protocol adherence rate	The rate of protocol adherence	90 days after randomization
Primary	Completion of follow-up visits	The rate of completion of follow-up visits	90 days after randomization
Secondary	28-day mortality	28-day mortality	28 days after randomization
Secondary	90-day mortality	90-day mortality	90 days after randomization
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	C-reactive protein (CRP)	C-reactive protein (CRP)	14 days after randomization
Secondary	Interleukin-6 (IL-6)	Interleukin-6 (IL-6)	14 days after randomization
Secondary	Interleukin-8 (IL-8)	Interleukin-8 (IL-8)	14 days after randomization
Secondary	Procalcitonin (PCT)	Procalcitonin (PCT)	14 days after randomization
Secondary	Neutrophil-to-lymphocyte Ratio (NLR)	Neutrophil-to-lymphocyte Ratio (NLR)	14 days after randomization
Secondary	Neutrophil elastase	Neutrophil elastase level of blood and alveolar fluid	14 days after randomization
Secondary	New-onset infection rate	Rate of new-onset infection	28 days after randomization
Secondary	Re-intubation rate	Rate of unplanned re-intubation	28 days after randomization
Secondary	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