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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 4
- 主要终点
- Recruitment rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Sivelestat sodium
Sivelestat sodium and dexamethasone placebo
干预措施: Sivelestat sodium (Drug)
Sivelestat sodium
Sivelestat sodium and dexamethasone placebo
干预措施: Dexamethasone placebo (Drug)
Dexamethasone
Dexamethasone and Sivelestat sodium placebo
干预措施: Dexamethasone (Drug)
Dexamethasone
Dexamethasone and Sivelestat sodium placebo
干预措施: Sivelestat sodium placebo (Drug)
Placebo
Sivelestat sodium placebo and dexamethasone placebo
干预措施: Sivelestat sodium placebo (Drug)
Placebo
Sivelestat sodium placebo and dexamethasone placebo
干预措施: Dexamethasone placebo (Drug)
结局指标
主要结局
Recruitment rate
时间窗: 90 days after randomization
The rate of recruitment
Recruitment compliance rate
时间窗: 90-day after randomization
The rate of recruitment compliance
Informed consent rate
时间窗: 90 days after randomization
The rate of informed consent
Protocol adherence rate
时间窗: 90 days after randomization
The rate of protocol adherence
28-day ventilator-free days
时间窗: 28 days after randomization
ventilator-free days within 28 days
Completion of follow-up visits
时间窗: 90 days after randomization
The rate of completion of follow-up visits
次要结局
- 90-day mortality(90 days after randomization)
- Interleukin-6 (IL-6)(14 days after randomization)
- Murray's acute lung injury score(14 days after randomization)
- 28-day organ support free day(28 days after randomization)
- 28-day length of stay(28 days after randomization)
- Sequential organ failure assessment (SOFA)(14 days after randomization)
- Interleukin-8 (IL-8)(14 days after randomization)
- 28-day mortality(28 days after randomization)
- C-reactive protein (CRP)(14 days after randomization)
- Procalcitonin (PCT)(14 days after randomization)
- Neutrophil-to-lymphocyte Ratio (NLR)(14 days after randomization)
- Neutrophil elastase(14 days after randomization)
- New-onset infection rate(28 days after randomization)
- Re-intubation rate(28 days after randomization)
- Adverse event(28 days after randomization)