Clinical trial NCT06387823: Efficacy and Safety of Sivelestat Sodium and Dexamethasone in the Treatment of ARDS
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Respiratory Distress Syndrome
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: Peking University
name: Shanghai Huilun Pharmaceutical Co., Ltd.
First posted: 2024-04-29
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 28-day ventilator-free days
timeFrame: 28 days after randomization
measure: Informed consent rate
timeFrame: 90 days after randomization
measure: Recruitment rate
timeFrame: 90 days after randomization
measure: Recruitment compliance rate
timeFrame: 90-day after randomization
measure: Protocol adherence rate
timeFrame: 90 days after randomization
measure: Completion of follow-up visits
timeFrame: 90 days after randomization
Secondary outcomes:
measure: 28-day mortality
timeFrame: 28 days after randomization
measure: 90-day mortality
timeFrame: 90 days after randomization
measure: 28-day length of stay
timeFrame: 28 days after randomization
measure: 28-day organ support free day
timeFrame: 28 days after randomization
measure: Sequential organ failure assessment (SOFA)
timeFrame: 14 days after randomization
measure: Murray's acute lung injury score
timeFrame: 14 days after randomization
measure: C-reactive protein (CRP)
timeFrame: 14 days after randomization
measure: Interleukin-6 (IL-6)
timeFrame: 14 days after randomization
measure: Interleukin-8 (IL-8)
timeFrame: 14 days after randomization
measure: Procalcitonin (PCT)
timeFrame: 14 days after randomization
measure: Neutrophil-to-lymphocyte Ratio (NLR)
timeFrame: 14 days after randomization
measure: Neutrophil elastase
timeFrame: 14 days after randomization
measure: New-onset infection rate
timeFrame: 28 days after randomization
measure: Re-intubation rate
timeFrame: 28 days after randomization
measure: Adverse event
timeFrame: 28 days after randomization
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Luoyang
country: China
facility: Luoyang Central Hospital
state: Henan
city: Yanan
country: China
facility: Yanan University Affiliated Hospital
state: Shaanxi
city: Mianyang
country: China
facility: The Third Hospital of Mianyang
state: Sichuan
Study officials:
affiliation: Peking Union Medical College
name: Bin Du, MD
role: STUDY_CHAIR
References: