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

Peking Union Medical College Hospital300 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

300

Conditions

Acute Respiratory Distress Syndrome

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (4)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

RECRUITING

Luoyang Central Hospital

Luoyang, Henan, China

NOT_YET_RECRUITING

Yanan University Affiliated Hospital

Yan’an, Shaanxi, China

RECRUITING

The Third Hospital of Mianyang

Mianyang, Sichuan, China

NOT_YET_RECRUITING

Outcomes

Primary Outcomes

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

Secondary Outcomes

28-day mortality

Time frame: 28 days after randomization

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.