Adaptive Clinical Trial Platform Testing New Treatments for Acute Hypoxemic Respiratory Failure and Critical Illness

What this Trial Is About

Researchers are evaluating new treatments for acute hypoxemic respiratory failure AHRF, a serious condition that affects millions worldwide each year and carries high risks of death and long-term health problems. This platform trial, called PRACTICAL, uses adaptive methods to test various interventions at different stages, including mechanical ventilation approaches, extracorporeal life support, drugs, and medical devices. The study aims to find better strategies to protect lungs and diaphragm function during ventilation and improve patient outcomes. The trial includes multiple domains studying different treatments or strategies. These include ultra-protective ventilation using extracorporeal carbon dioxide removal, various invasive mechanical ventilation strategies, corticosteroid use in early and extended phases, nebulized furosemide, positive end-expiratory pressure settings during extracorporeal support, fludrocortisone for airspace disease, and inspiratory muscle training. Some domains are observational, collecting data and biomarkers in immunocompromised patients or examining patient-ventilator interactions. Participants will be randomized to different treatment arms or observed, depending on the domain. Participants will undergo assessments including physiological and biological measurements, mechanical ventilation monitoring, and evaluation of clinical outcomes such as mortality, ventilator-free days, organ failure, and long-term cognitive and physical function. Data will be collected daily or at specified time points up to 180 days. The study uses Bayesian adaptive analysis to efficiently evaluate efficacy and safety of interventions. The total participation time varies by domain but includes active treatment periods, follow-up, and feasibility assessments over months to years.

Platform of Randomized Adaptive Clinical Trials in Critical Illness