Clinical Centers (CC) for the NHLBI Prevention and Early Treatment of Acute Lung

描述（由申请人提供）：PETAL RFA是一个令人兴奋的倡议，旨在创建一个多学科网络，可以开发和开展多中心临床试验，以评估预防和/或治疗急性呼吸窘迫综合征（ARDS）的有前途的疗法和方法。我们建议加入这个网络。该提案的主要机构是贝斯以色列女执事医疗中心（BIDMC），卫星站点是马萨诸塞州总医院（MGH）和密西西比大学。总的来说，我们的站点拥有急诊医学、麻醉师和重症监护医师之间以及我们各个研究站点之间的独特而强大的合作记录。这种经验和专门知识直接解决了提案的意图。我们的研究团队在脓毒症和急性呼吸窘迫综合征（ARDS）方面有着持续的、成功的、高影响的研究记录，涵盖急诊医学、围手术期医学和重症监护。我们的网站已经成为阿司匹林肺损伤预防试验（LIPS-A）的协调中心，这在很多方面都是PETAL网络所设想的研究类型的原型。因此，我们的理想定位是创建一个高性能的PETAL临床中心，并为网络领导和科学方向做出贡献。

DESCRIPTION (provided by applicant): The PETAL RFA is an exciting initiative to create a multi-disciplinary network that can develop and conduct multi-center clinical trials to evaluate promising therapies and approaches for preventing and/or treating acute respiratory distress syndrome (ARDS). We propose participation in this network. The lead institution for this proposal is Beth Israel Deaconess Medical Center (BIDMC), and satellite sites are Massachusetts General Hospital (MGH) and the University of Mississippi. In aggregate, our site possesses a uniquely strong track record of pre- existing collaboration between emergency medicine, anesthesiologists and intensive care physicians, as well as between our individual study sites. This experience and expertise directly addresses the intent of the proposal. Our research team has a sustained, proven track record of successful, high-impact studies in sepsis and ARDS spanning emergency medicine, perioperative medicine and critical care. Our site is already serves as the coordinating center for the Lung Injury Prevention Trial with Aspirin (LIPS-A) which is in many ways the prototype for the type of study envisioned for the PETAL network. Thus, we are ideally positioned to create an extremely high-performing PETAL clinical center, as well as to contribute to network leadership and scientific direction. We also submit two proposals for clinical studies to be undertaken by the PETAL network. Both of these studies are based upon strong preliminary data from our institutions. The first study will examine the ability of rosuvastatin to prevent development of ARDS in patients at risk for development of the syndrome. While statin drugs have previously been tested as a treatment for ARDS there is substantial evidence to suggest that they may be more effective as a prevention strategy. This study builds on our success as the clinical coordinating center of the LIPS-A study. Our second proposed study will test the ability of using personalized physiology, the patient's own pleural pressure as measured using esophageal balloons, to set the level of positive end-expiratory pressure in patients with established ARDS. This proposal will support a phase 3 trial of this promising modality. The expertise and experience of the investigators involved in this proposal will allow the BIDMC clinical site to contribute substantially to the scientific success of the PETAL network.