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

NHLBI 急性肺疾病预防和早期治疗临床中心 (CC)

• 批准号: 9266811
• 负责人: NATHAN I SHAPIRO
• 金额: $ 45.78万
• 依托单位: BETH ISRAEL DEACONESS MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-06-17 至 2021-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9266811
• 关键词: Accident and Emergency department; Acute; Address; Adult Respiratory Distress Syndrome; Affect; Aftercare; Anesthesia procedures; Aspirin; Caring; Cessation of life; Clinical; Clinical Research; Clinical Trials; Collaborations; Critical Care; Critical Illness; Data; Data Collection; Development; Early treatment; Emergency Department Physician; Emergency Medicine; Enrollment; Esophageal; Functional disorder; Funding; General Hospitals; Goals; Health Care Costs; Heart Arrest; Home environment; Individual; Institutes; Institution; Intensive Care; Intensive Care Units; Interdisciplinary Study; Israel; Joints; Lead; Leadership; Lung; Manuscripts; Massachusetts; Measures; Medical; Medical center; Medicine; Methodology; Methods; Mississippi; Modality; Morbidity - disease rate; Multi-Institutional Clinical Trial; National Heart, Lung, and Blood Institute; Organ failure; Patients; Perioperative; Pharmaceutical Preparations; Phase III Clinical Trials; Physicians; Physiology; Pleural; Positioning Attribute; Positive-Pressure Respiration; Prevention; Prevention strategy; Prevention therapy; Prevention trial; Procedures; Protocols documentation; Public Health; Publications; Publishing; Reporting; Research; Research Design; Research Infrastructure; Research Personnel; Resources; Risk; Sepsis; Shock; Site; Syndrome; Testing; United States; Universities; Work; Writing; base; clinical research site; cost; experience; interdisciplinary approach; lung injury; medical schools; mortality; multidisciplinary; pressure; prevent; prototype; public health relevance; rosuvastatin; septic; success

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.

描述（由申请人提供）：PETAL RFA是一项令人兴奋的倡议，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）的有前途的疗法和方法。我们建议加入这一网络。该提案的牵头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，我们的研究中心在急诊医学、麻醉师和重症监护医生之间以及我们的各个研究中心之间的预先存在的合作方面拥有独特的良好记录。这种经验和专门知识直接涉及提案的意图。我们的研究团队在败血症和ARDS的成功，高影响力的研究方面拥有持续，可靠的记录，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，该试验在许多方面都是PETAL网络设想的研究类型的原型。因此，我们处于理想的位置，可以创建一个非常高性能的PETAL临床中心，并为网络领导和科学方向做出贡献。 我们还提交了两项由PETAL网络进行临床研究的建议。这两项研究都是基于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有发生综合征风险的患者发生ARDS的能力。虽然他汀类药物先前已被测试为治疗ARDS，但有大量证据表明，它们作为预防策略可能更有效。这项研究建立在我们作为LIPS-A研究临床协调中心的成功基础上。我们的第二项研究将测试使用个性化生理学的能力，即使用食管球囊测量患者自身的胸膜压，以设定患有ARDS的患者的呼气末正压水平。该提案将支持这一有希望的模式的第三阶段试验。 参与本提案的研究者的专业知识和经验将使BIDMC临床研究中心能够为PETAL网络的科学成功做出重大贡献。