Pirfenidone to prevent fibrosis in acute respiratory distress syndrome: The PIONEER study protocol
Monti G. Marzaroli M. Tucciariello M.T. Ferrara B. Meroi F. Nakhnoukh C. Zambon M. Borghi G. Guarracino F. Manazza M. Ajello V. Belletti A. Biuzzi C. Plumari V. Filippini M. Cuffaro R. Racanelli G. Pontillo D. Rauch S. Oliva F.M. Tescione M. Baiardo Redaelli M. Melegari G. Maj G. Navalesi P. Gerardi M. Caccioppola A. Bruni A. Ballotta A. Ferri C. Orso D. Di Benedetto V. Baldassarri R. Franceschini G. Alamami A. Pasin L. Putzu A. Romero Garcia C.S. Chen Y.-S. Noto A. Yavorovskiy A. Hajjar L.A. Cortegiani A. Likhvantsev V. Konkayev A. Finco G. Sales G. Brazzi L. Paternoster G. Bellomo R. Zangrillo A. Landoni G. Di Tomasso N. Bonizzoni M.A. Borello M. Chiodi B. DAmico F. De Piccoli N. Fiorito S. Fresilli S. Giardina G. Labanca R. Lembo R. Licheri M. Losiggio R. Marmiere M. Nardelli P. Notarianni L. Nutta A. Oriani A. Ortalda A. Pieri M. Pruna A. Ronca E. Scquizzato T. Turi S. Vietri S. Tomasi E. Veneziano M. Asiller Ö.Ö. Azimova B. Kabibulatov A. Doroni L. Villano M. Berikashvili L. Kadantseva K. Piva S. Carmela Izzi M. Milano S. Sannicandro M.S. Petrun A.M. Montrucchio G. Sanna V. Simonetti U. Ollosu M. Sardo S. Bresssan S. DAndrea N. Lugano M. Roveri G. Seraglio P. Ippolito M. Catalisano G. Perna R. Farinaccio A. Flaminio M. Scaini R. Corradi F. Cucciolini G. Scopelliti C. Vadalà E.G. Ricciardi R. Taniguchi L.U. Mendes P.V. Krzych Cabrini L.
June 2025Elsevier Inc.
Contemporary Clinical Trials
2025#153
Background: Pulmonary fibrosis is a major complication of the Acute Respiratory Distress Syndrome (ARDS). Pirfenidone is an approved treatment for idiopathic pulmonary fibrosis. It may attenuate ARDS-related fibrosis and decrease the need for prolonged ventilation. Accordingly, we aimed to evaluate the effect of pirfenidone on ventilator-free days in patients with ARDS. Methods: In a multi-center, randomized, double-blind, placebo-controlled trial, we plan to randomly assign 130 adults invasively ventilated for ARDS to receive pirfenidone or placebo for up to 28 days. The primary outcome is days alive and ventilator free at 28 days. Secondary outcomes include ICU-free days, hospital free days all at 28 day, ICU mortality and hospital mortality. We will also assess fibroproliferative changes on high-resolution CT scans at ICU discharge and quality of life. Data analysis will be on an intention-to-treat basis. Discussion: The trial is ongoing and currently recruiting. It will be the first randomized controlled study to investigate whether, compared to placebo, pirfenidone increases the number of days alive and ventilator-free in patients with ARDS. Its double-blind multicenter design will provide internal validity, minimal bias, and a degree of external validity. If our hypothesis is confirmed, this treatment would justify larger trials of this intervention. Trial registration: This trial was registered on ClinicalTrials.gov with the trial identification NCT05075161.
ARDS , Critical care , Fibrosis , Intensive care , Mechanical ventilation , Pirfenidone
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Department of Anaesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy
School of Medicine, Vita-Salute San Raffaele University, Milan, Italy
Cardiovascular Anesthesia and ICU, San Carlo Hospital, Potenza, Italy
Department of Emergency “Santa Maria Della Misericordia”, Azienda Sanitaria Universitaria Friuli Centrale, University Hospital of Udine, Udine, Italy
Anestesia e Rianimazione, Ospedale Uboldo – Cernusco sul Naviglio ASST Melegnano e Martesana, Cernusco Sul Naviglio, Italy
Department of Cardiothoracic and Vascular Anaesthesia and Intensive Care, Azienda Ospedaliero Universitaria Pisana, Pisa, Italy
Department of Cardiothoracic Anesthesia, University Hospital Tor Vergata, Rome, Italy
Department of Medical Science, Surgery and Neurosciences, Trauma Anesthesia and Intensive Care Unit, University Hospital of Siena, Siena, Italy
Department of Anesthesia, Intensive Care and Emergency, ASST Spedali Civili University Hospital, Brescia, Italy
Anesthesia and ICU 1° Department, Casa Sollievo della Sofferenza Opera San Pio da Pietrelcina Hospital, San Giovanni Rotondo, Italy
Department of Anesthesia and Intensive Care Medicine, Merano Hospital, Merano, Italy
Anesthesia and Intensive Care Unit, Grande Ospedale Metropolitano, Reggio Calabria, Italy
Department of Biotechnologies and Life Science, University of Insubria, Varese, Italy
Azienda Ospedaliera Ospedale di Circolo e Fondazione Macchi di Varese, Varese, Italy
Department of Anaesthesia and Intensive Care, AOU Policlinico di Modena, Modena, Italy
Cardiothoracic and Vascular Anesthesia and Intensive Care, AOU SS Antonio e Biagio e Cesare Arrigo, Alessandria, Italy
Department of Medicine, University of Padua, Padua, Italy
Anesthesia and Intensive Care, Padua University Hospital, Padua, Italy
GVM Ospedale Santa Maria, Bari, Italy
Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Milan, Italy
Department of Medical and Surgical Sciences, Magna Graecia University, Catanzaro, Italy
Department of Cardiac Anesthesia and Intensive Care Unit, Cardiac Anaesthesia and Intensive Care Unit, Centro Cardiologico Monzino, IRCSS, Milan, Italy
Hospital Pharmacy, IRCCS San Raffaele Scientific Institute, Milan, Italy
Department of Critical Care Medicine, Hamad General Hospital, Doha, Qatar
Anesthesia and Intensive Care Unit, Casa di Cura Villa Maria, Padua, Italy
Division of Anaesthesiology, Department of Anaesthesiology, Pharmacology, Intensive Care, and Emergency Medicine, Geneva University Hospitals, Geneva, Switzerland
Department of Anaesthesiology and Critical Care, Hospital General Universitario De Valencia, Valencia, Spain
Methodology Department, European University of Valencia, Valencia, Spain
National Taiwan University Hospital, Taipei, Taiwan
Division of Anesthesia and Critical Care, Department of Human Pathology of the adult and evolutive age “Gaetano Barresi”, University of Messina, Messina, Italy
Department of Anesthesiology and Intensive Care, I.M. Sechenov First Moscow State Medical University of the Russian Ministry of Health, Moscow, Russian Federation
Critical Care and Emergency Department, University of São Paulo, São Paulo, Brazil
Department of Precision Medicine in Medical, Surgical and Critical Care (Me.Pre.C.C.), University of Palermo, Palermo, Italy
Department of Anaesthesia, Intensive Care and Emergency, University Hospital Policlinico Paolo Giaccone, Palermo, Italy
Federal Research and Clinical Center of Intensive Care Medicine and Rehabilitology, Moscow, Russian Federation
Astana Medical University, Astana, Kazakhstan
National Scientific Center of Traumatology and Orthopedia, Astana, Kazakhstan
Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy
Department of Surgical Sciences, University of Turin, Turin, Italy
Department of Health Science, Anesthesia and ICU, School of Medicine University of Basilicata San Carlo Hospital, Potenza, Italy
Department of Critical Care, University of Melbourne, Melbourne, Australia
Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, Australia
Department of Anesthesiology and Intensive Care, Faculty of Medicine, Ankara University, Ankara, Turkey
Department of Medical and Surgical Specialties, Radiological Sciences and Public Health, University of Brescia, Brescia, Italy
Cardiovascular Anesthesia and ICU, San Carlo Hospital, Potenza, Italy
Department of Anesthesiology, Intensive Therapy and Pain Management, University Medical Centre Maribor, Maribor, Slovenia
Faculty of Medicine, University of Maribor, Maribor, Slovenia
Department of Anesthesia, Intensive Care and Emergency, A.O.U. Città della Salute e della Scienza, Turin, Italy
Department of Emergency “Santa Maria Della Misericordia”, Azienda Sanitaria Universitaria Friuli Centrale, University Hospital of Udine, Udine, Italy
Department of Anesthesia and Intensive Care Medicine, Merano Hospital, Merano, Italy
Casa Sollievo della Sofferenza Opera San Pio da Pietrelcina Hospital, San Giovanni Rotondo, Italy
Department of Surgical, Medical and Molecular Pathology and Critical Care Medicine, University of Pisa, Pisa, Italy
Department of Anesthesia and Critical Care Medicine, Azienda Ospedaliero Universitaria Pisana, Pisa, Italy
Anesthesia and Intensive Care Unit, Grande Ospedale Metropolitano, Reggio Calabria, Italy
Operative Research Unit of Anesthesia and Intensive Care, Campus Bio-Medico University Hospital, Rome, Italy
Departament of Acute Medicine, Medical University of Silesia in Katowice, Silesian Centre for Heart Disease, Zabrze, Poland
Department of Anaesthesia and Intensive Care
School of Medicine
Cardiovascular Anesthesia and ICU
Department of Emergency “Santa Maria Della Misericordia”
Anestesia e Rianimazione
Department of Cardiothoracic and Vascular Anaesthesia and Intensive Care
Department of Cardiothoracic Anesthesia
Department of Medical Science
Department of Anesthesia
Anesthesia and ICU 1° Department
Department of Anesthesia and Intensive Care Medicine
Anesthesia and Intensive Care Unit
Department of Biotechnologies and Life Science
Azienda Ospedaliera Ospedale di Circolo e Fondazione Macchi di Varese
Department of Anaesthesia and Intensive Care
Cardiothoracic and Vascular Anesthesia and Intensive Care
Department of Medicine
Anesthesia and Intensive Care
GVM Ospedale Santa Maria
Department of Anesthesia
Department of Medical and Surgical Sciences
Department of Cardiac Anesthesia and Intensive Care Unit
Hospital Pharmacy
Department of Critical Care Medicine
Anesthesia and Intensive Care Unit
Division of Anaesthesiology
Department of Anaesthesiology and Critical Care
Methodology Department
National Taiwan University Hospital
Division of Anesthesia and Critical Care
Department of Anesthesiology and Intensive Care
Critical Care and Emergency Department
Department of Precision Medicine in Medical
Department of Anaesthesia
Federal Research and Clinical Center of Intensive Care Medicine and Rehabilitology
Astana Medical University
National Scientific Center of Traumatology and Orthopedia
Department of Medical Sciences and Public Health
Department of Surgical Sciences
Department of Health Science
Department of Critical Care
Australian and New Zealand Intensive Care Research Centre
Department of Anesthesiology and Intensive Care
Department of Medical and Surgical Specialties
Cardiovascular Anesthesia and ICU
Department of Anesthesiology
Faculty of Medicine
Department of Anesthesia
Department of Emergency “Santa Maria Della Misericordia”
Department of Anesthesia and Intensive Care Medicine
Casa Sollievo della Sofferenza Opera San Pio da Pietrelcina Hospital
Department of Surgical
Department of Anesthesia and Critical Care Medicine
Anesthesia and Intensive Care Unit
Operative Research Unit of Anesthesia and Intensive Care
Departament of Acute Medicine
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