Evaluation of the Efficacy of Inhaled Nitric Oxide Therapy in Patients With Moderate to Severe Acute Respiratory Distress Syndrome: A Multicenter, Prospective, Randomized Controlled Clinical Trial (ENARCT-ARDS)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 536
- 试验地点
- 1
- 主要终点
- 28-day mortality
研究概览
简要总结
The goal of this clinical trial is to evaluate whether inhaled nitric oxide (iNO), added to standard care, can reduce mortality in adults with moderate-to-severe Acute Respiratory Distress Syndrome (ARDS). The main questions it aims to answer are:
Does iNO therapy reduce 28-day all-cause mortality compared to standard care alone? Does iNO therapy increase the number of ventilator-free days through day 28? If there is a comparison group: Researchers will compare the group receiving iNO plus standard care with the group receiving placebo plus standard care to see if iNO improves survival and other clinical outcomes.
Participants will:
Be randomly assigned to receive either iNO or a placebo through the ventilator.
Receive all other standard treatments for ARDS as per current guidelines. Be closely monitored for 28 days to track survival, time on the ventilator, and safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Age ≥ 18 years.
- •Patients diagnosed with moderate-to-severe ARDS according to the 2023 Global (or international) criteria.
排除标准
- •Known allergy to iNO.
- •Congenital methemoglobinemia.
- •End-stage chronic lung disease (e.g., lung cancer, prior pneumonectomy/lung transplant).
- •Shock (norepinephrine >0.5 μg/kg/min or equivalent for >6 hours) at treatment initiation.
- •Pulmonary hypertension (PASP >45 mmHg by echo or mPAP ≥25 mmHg by catheterization).
- •Serum creatinine >2.5 mg/dL (221 μmol/L).
- •Major bleeding (e.g., intracranial, pulmonary) or platelet count <20×10⁹/L.
- •Expected ICU/mechanical ventilation <24 hours.
- •Pre-enrollment ECMO therapy.
- •Any investigator-assessed unsuitability for the study.
结局指标
主要结局
28-day mortality
时间窗: within 28 days after randomization
The primary outcome was 28-day all-cause mortality, defined as death from any cause occurring within 28 days following randomization. All patients must be followed up through day 28, regardless of hospital discharge status.
次要结局
未报告次要终点