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

描述(由申请人提供)：Petal RFA是一项令人兴奋的创举，旨在创建一个多学科网络，可以开发和进行多中心临床试验，以评估预防和/或治疗急性呼吸窘迫综合征(ARDS)的有前景的疗法和方法。我们建议加入这个网络。这项提议的牵头机构是贝丝以色列女执事医疗中心(BIDMC)，附属机构是马萨诸塞州总医院(MGH)和密西西比大学。总体而言，我们的网站在急诊医学、麻醉师和重症监护医生之间以及我们的个人研究网站之间先前存在的合作方面拥有独特的强大记录。这些经验和专业知识直接解决了提案的意图。我们的研究团队在脓毒症和ARDS方面拥有持续、可靠的高影响力研究记录，研究范围涵盖急诊医学、围手术期医学和危重护理。我们的网站已经作为阿司匹林(LIPS-A)肺损伤预防试验的协调中心，在许多方面，这是花瓣网络所设想的研究类型的原型。因此，我们处于创建一个极高性能的花瓣临床中心的理想位置，并为网络领导和科学方向做出贡献。 我们还提出了两项由Petal网络进行的临床研究的建议。这两项研究都是基于来自我们机构的强有力的初步数据。第一项研究将 检查瑞舒伐他汀预防ARDS高危患者发生ARDS的能力。尽管他汀类药物以前曾被测试为ARDS的治疗方法，但有大量证据表明，作为一种预防策略，它们可能更有效。这项研究建立在我们作为唇部临床协调中心的成功基础上--一项研究。我们第二项拟议的研究将测试使用个性化生理学的能力，即患者自己使用食道气囊测量的胸膜压力，来设置已确诊的ARDS患者的呼气末正压水平。这项提议将支持这一前景看好的模式的第三阶段试验。 参与这项提议的研究人员的专业知识和经验将使BIDMC临床站点能够为Petal网络的科学成功做出重大贡献。

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.