EUCTR2017-002867-16-FR进行中（未招募）1 期
Procollagen-3 driven corticosteroids for persistent Acute Respiratory Distress Syndrome - ProCoCo
Assistance Pubique Hôpitaux de Marseille0 个研究点目标入组 356 人开始时间: 2017年7月18日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 356
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Age >= 18 years
- •Continuous endotracheal ventilation
- •Moderate – severe ARDS according to Berlin definition (see appendix) with PaO2/FiO2 = 200 with PEEP>=5 cm H2O
- •(For patients under ECMO, arterial blood gases have to be measured with a pump blood flow of 3 L/min and a FDO2 of 0.21 and FiO2 on mechanical ventilator of 1)
- •Date of ARDS onset : >=day 5 and = day 14 after the onset of ARDS criteria (regardless of ARDS severity)
- •Procollagen III above 9 µg/L in a bronchoalveolar lavage performed by the attending physician between day 3 and day 13 after the onset of ARDS and realized within 5 days prior to randomization
- •Written informed consent of patient or proxy
- •Patients covered by or having the rights to social security
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 178
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 178
排除标准
- •Lack of informed consent
- •Patients deprived of freedom or under legal authority
- •Patients not insured under the national social security system
- •Known pregnancy or breast feeding
- •Participation to another interventional trial within 30 days with mortality or ventilator free days as the main endpoint
- •Clinical evidence of active untreated infection
- •A known, undrained abscess (e.g., Staphylococcal lung abscess or loculated empyema or intra-abdominal abscess)
- •Intravascular nidus of infection (e.g., bacterial or fungal endocarditis or suppurate thrombophlebitis), even if it is being treated with antibiotics.
- •Disseminated fungal infection (EORTC criteria), even if being treated
- •Active tuberculosis, even if being treated
- •New nosocomial infection with less than 72 hours of antibiotics
- •Burns requiring skin grafting
- •Acquired immunodeficiency syndrome
- •Treatment with corticosteroids (> 200 mg/day of hydrocortisone or equivalent at any moment during the month preceding inclusion)
- •Cytotoxic therapy within 3 weeks
- •Myeloproliferative syndrome
- •SAPS II score at the time of enrollment > 75
- •Presence of an advanced directive to withhold life-sustaining treatment or decision to withhold life-sustaining treatment
- •Chronic respiratory disease requiring home oxygen therapy or ventilation
- •Chronic interstitial or fibrotic lung disease or diffuse alveolar hemorrhage from vasculitis
- •Acute or chronic liver disease defined as a Child-Pugh score of C.
- •Preexisting neurological disease with diaphragmatic components (traumatic tetraplegia, amyotrophic lateral sclerosis, diaphragm paralysis…)
- •Myasthenia gravis, Guillain-Barré Syndrome and others polyradiculoneuropathies
- •Known or suspected allergy to methylprednisolone
研究者
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