Randomized Controlled Phase II Trial of Poractant Alfa (Curosurf®) by Fiberoptic Bronchoscopy-directed Endobronchial Administration in Acute Respiratory Distress Syndrome (ARDS) Due to COVID-19 Viral Pneumonia
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Evolution of the PaO2 / FiO2 ratio between the measurements taken before (t0) and one hour after the end of the invasive procedure (H1).
研究概览
简要总结
Surfactant replacement therapy (SRT) improves oxygenation and survival in NRDS and some infant ARDS. SRT was tried in adult ARDS with conflicting results. Research by Filoche and Grotberg helped to understand the failure of previous clinical trials and yielded a strong scientific rationale for SRT success, now allowing to design a new administration protocol for SRT in adults, to be tested by this clinical trial in COVID-19 adult ARDS patients.
Patients will be randomized to receive either a bronchial fibroscopy alone (with aspiration of secretions) or a bronchial fibroscopy with administration of 3 mL/kg of a solution of poractant alpha diluted to 16 mg/mL and distributed into each of the 5 lobar bronchi.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 18 years
- •Intensive care unit admission.
- •Intubation and mechanical ventilation since less than 72h.
- •Positive end-expiratory pressure ≥ 5 cmH2O.
- •Acute respiratory distress syndrome following Berlin definition.
- •PaO2/FiO2 ratio < 150 mmHg during at least 3 hours despite PEP trial.
- •Compliance of the respiratory system < 50 mL/cmH2O
排除标准
- •Contraindication to prone position.
- •Pregnancy.
- •Weight < 40 kg
- •height < 140 cm or height > 190 cm.
- •Profuse bronchorrhea (at least 1 succion per hour during 3 hours).
- •Other significant cause than ARDS to the respiratory failure.
- •Decision to limit active therapies.
- •No arterial line in place.
- •Obesity with weight / height ratio > 1 kg / cm.
- •Impossible to give neuromuscular blockers (e.g. drug unavailable owing to global pandemia).
- •Severe chronic respiratory failure with oxygen at home.
- •Other severe acute or chronic organ faillure (eg severe liver cirrhosis, severe chronic cardiac failure).
- •History of pneumonectomy or pulmonary lobectomy.
- •Patient scheduled for extracorporeal membrane oxygenation.
- •Known hypersensibility to Curosurf.
- •Contraindication to bronchial fibroscopy.
- •Person under legal protection.
研究组 & 干预措施
Surfactant arm
patient receiving the surfactant
干预措施: poractant alfa (Drug)
结局指标
主要结局
Evolution of the PaO2 / FiO2 ratio between the measurements taken before (t0) and one hour after the end of the invasive procedure (H1).
时间窗: 1 hour post treatment
次要结局
- Oxygenation : area under the PaO2 / FiO2 curve.(up to Day 1 and up to Day 7)
- Oxygenation : PaO2 / FiO2 ratio.(up to Day 1 and up to Day 7)
- Oxygenation : area under the SpO2 curve.(up to Hour 1 and up to Hour 24)
- Evolution of thoraco-pulmonary compliance (mL / mbar) between before and one hour after the procedure.(1 hour)
- Overall survival rate(at 28 days, 56 days.)
- Mortality rate at discharge from the intensive care unit.(through study completion, an average of 6 months.)
- Mortality rate at discharge from the hospital.(through study completion, an average of 6 months.)
- Number of ventilator-free days(Day 28, Day 56)
- Number of prone position sessions.(up to 56 days)
- Time between inclusion and the last prone position session.(up to 56 days)
研究者
Dr Christophe LENCLUD
Principal Investigator
Versailles Hospital