Pirfenidone to Prevent Fibrosis in ARDS. A Randomized Controlled Trial - PIONEER
Acute respiratory distress syndrome (ARDS) is a severe form of acute lung injury and a major cause of Intensive Care Unit (ICU) admission worldwide. Despite a large number of randomized clinical trials, a specific and effective pharmacological approach for patients with ARDS is still lacking. Fibroproliferation is a crucial part of the host defence response, and severe fibrotic lung disease affects ARDS patients even years after acute phase resolution. Pirfenidone is an oral anti-fibrotic drug, approved and largely used for treatment of idiopathic pulmonary fibrosis (IPF). The effect of Pirfenidone in ARDS has been evaluated only in animal models. This is a randomized controlled study to evaluate for the first time the efficacy of Pirfenidone in ARDS.
∙ Concomitant presence of:
• ARDS (moderate and severe) - Berlin definition
‣ Within 1 week of a known clinical insult or new or worsening respiratory symptoms
⁃ Bilateral opacities on CXR which are not fully explained by effusions, lobar/lung collapse or nodules
⁃ Respiratory failure not fully explained by cardiac failure or fluid overload
⁃ PaO2/FiO2\<200 mmHg with PEEP\<=5 cmH2O (invasive mechanical ventilation)
• 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.
• Age \>=18 years