Preventive and Early Treatment of Acute Lung Injury Clinical Trials Network- Pgh

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DESCRIPTION (provided by applicant): The University of Pittsburgh seeks to join the PETAL network, with Penn State University Hershey Medical Center as our satellite partner. Our goal is to participate fully in the PETAL network as a Clinical Center, with the shared mission of achieving better understanding, treatment, and outcomes for those with or at risk for acute lung injury (ALI) or acute respiratory distress syndrome (ARDS). We have assembled a team of senior thought leaders and talented investigators with expertise in basic, translational, clinical and outcomes research relevant to ALI/ARDS. We detail the qualifications of our dual PIs, presenting evidence for their ability to work as a pat of the network leadership in defining work, operational solutions needed, future opportunities, and creation of material to share the scientific results for PETAL research efforts. We next note the features that allow our clinical center to successfully participate, including meeting enrollment needs and doing so in key and early care sites. Our clinical center proposes two interventional studies for PETAL evaluation and implementation: A trial of nebulized DNAase as an ARDS-prevention strategy; and trial of protocolized neuromuscular blockade as an ARDS early treatment strategy. We describe the scientific background, key features of each intervention, present our plans that include clinical outcome assessment and focused biomarker collection, and consider threats and contingencies where applicable. We also describe our research and clinical environments, IRB support, procedures to ensure appropriate human subjects protection, to obtain and manage all data and biospecimens with appropriate security, to comply with all training and regulatory requirements, and to maintain local structured oversight to ensure optimal participation within the network.