The overall aim of this proposal is to establish Einstein-PETAL under the Albert Einstein College of Medicine as a Clinical Center in the PETAL Network.
The specific aims of Einstein-PETAL are: 1) To optimize the identification and recruitment of a diverse population of patients into PETAL trials by building upon the expertise and established collaboration between critical care and emergency medicine. 2) To facilitate the efficiency and operation of the PETAL Network by leveraging the local and national infrastructure, resources, and expertise of the sites and PIs, including the US Critical Illness an Injuries Trials Group, the CTSA supported Einstein- Montefiore Institute of Clinical and Translational Research (ICTR) with its multiple cores including the Einstein-Montefiore ICTR Clinical Research Informatics Core (RIC), and the electronic medical records at each site. 3) To propose for PETAL two significant clinical trials (Checklist for Lung Injury Prevention (CLIP) and Lung Injury Prevention Study Aspirin II (LIPS-A II)) aimed at the prevention of ARDS and mortality in patients at high risk for ARDS. To achieve these objectives, we have assembled institutions in New York City with outstanding clinical and academic critical care and emergency medicine delivery systems. These sites include the Montefiore Medical Center and its satellite site, the Mount Sinai Medical Center. Together these sites in Manhattan and the Bronx represent 126 adult medical and surgical intensive care unit beds that admitted 6,873 patients in 2012, a busy critical care consultative / rapid response team that sees over 6,619 patients a year, and one of the busiest EDs in the country with over 350,000 adult visits a year. The critical care and emergency medicine services are supplemented by strong institutional research infrastructure and support. The deliverables will include: participation of the PI and co-PI, with their expertise in ARDS prevention and emergency research, on the PETAL steering committees, a commitment to enroll 40 patients a year for the 5 1/2 years of enrollment into PETAL trials, and to implement high quality and timely study procedures and data and sample collection, as per our objectives above.
PETAL represents the first instrumental step towards prevention of acute organ failure that may significantly reduce both the mortality and the comorbidities associated with acute critical illness. The two proposed clinical trials, if proven effective, are cheap and readily available for rapid implementation to improve outcomes for large populations of injured patients. Einstein-PETAL is uniquely and optimally well suited to conduct PETAL trials in a diverse population of patients.