The purpose of the NHLBI sponsored Prevention and Early Treatment of Acute Lung Injury (PETAL) Clinical Trials Network is to constitute a network of Clinical Centers (CC) to collaborate with the Clinical Coordinating Center (CCC) to develop and conduct randomized controlled clinical trials to prevent or treat, and/or improve the outcome of patients with, or who are at risk for, Acute Lung Injury (ALI) or the Acute Respiratory Distress Syndrome (ARDS). Studies conducted by this Network are expected to emphasize prevention, early treatment and multidisciplinary approaches. The Network will consist of approximately eleven Clinical Centers (CCs) and a Clinical Coordinating Center (CCC). Each CC will have two principal investigators, one representing pulmonary and/or critical care medicine and the other representing a specialty with early access to patients at risk for lung injury, such as emergency medicine. Each CC must consist of a primary hospital and at least one other hospital. Each CC will be expected to enroll a minimum of 40 subjects per year for 5.5 years. The "Ohio Consortium Clinical Center" will consist of four major medical institutions in the state of Ohio: Cleveland Clinic, The Ohio State University in Columbus, University of Cincinnati and Summa Health System in Akron. These institutions all treat a large number of critically ill patients, and the investigators and research coordinators of the Ohio Consortium Clinical Center are experienced in the treatment of patients with ALI, and patients at-risk to develop ALI. The personnel of the Ohio Consortium Clinical Center includes two physicians who have served as Clinical Center PIs for the NHLBI sponsored ARDS Clinical Trial Network and two other physicians who have served as site PIs in the NHLBI sponsored multi-center "ProCESS" trial - (Protocolized Care for Early Septic Shock). The Ohio Consortium Clinical Center proposes two clinical trials: 1)Keratinocyte Growth Factor (KGF) for The Prevention or Treatment of Early ALI Due to Infectious Pneumonia and 2) Zinc supplementation for Acute Lung Injury Prevention (ZAP Trial).
Acute lung injury is a serious condition (about 20% of patients die) with multiple causes or risk factors, including pneumonia, severe infection anywhere in the body (sepsis), and trauma. The PETAL Network will evaluate treatments that might be effective in patients with acute lung injury or in patients at-risk for developing it. The Ohio Consortium, which includes four major medical centers in Ohio, specifically proposes two trials: 1) the use of early zinc supplementation, and 2) the use of keratinocyte growth factor (KGF).