PIrfenidone to prevent fibrOsis in ARDS. A RaNdomizEd controllEd tRial (PIONEER) GR-2019-12371063 - Pioneer

OSPEDALE SAN RAFFAELE0 个研究点目标入组 130 人开始时间: 2021年6月7日最近更新: 2022年3月2日

适应症

试验速览

暂无简介。

•Concomitant presence of:
•1. ARDS (moderate and severe)
•2. Inflammatory ARDS phenotype (28), defined by at least one of the following:
•- High plasma levels of inflammatory biomarkers
•- Vasopressor dependence
•- Lower serum bicarbonate or increased serum lactate
•-Informed consent expressed by the patient or by legal representative or on the Ethical Committee indication.
•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 65
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 65

•1. Intubated and mechanically ventilated via an endotracheal or tracheostomy tube (>7 days) up to the time of randomization
•2. ARDS severe or moderate for more than 36 hours
•3. Untreated pulmonary embolism, pleural effusion or pneumothorax as the primary cause of ARF
•4. ARF fully explained by left ventricular failure or fluid overload
•5. Consent declined
•6. Severe chronic respiratory disease requiring domiciliary ventilation
•7. Clinical suspicion for significant restrictive lung disease
•8. Pregnant women ore women of childbearing potential who are sexually active
•9. Known allergy to pirfenidone
•10.Concomitant use of fluvoxamine
•11. Known severe hepatic failure
•12. Known severe renal failure or necessity of dialysis not related to acute disease
•13. Little chance of survival (SAPS II score>75)

发起方

OSPEDALE SAN RAFFAELE