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是一项令人兴奋的举措，旨在创建一个多学科网络，该网络可以开发和进行多中心临床试验，以评估有希望的疗法和方法，以防止和/或治疗急性呼吸窘迫综合征（ARDS）。我们建议参与该网络。该提案的主要机构是贝丝以色列执事医疗中心（BIDMC），卫星站点是马萨诸塞州综合医院（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师以及我们的个体研究地点之间的现有合作中具有独特的良好记录。这种经验和专业知识直接解决了该提案的意图。我们的研究团队拥有涉及急诊医学，围手术医学和重症监护的败血症和ARDS的成功，高影响力研究的持续，可靠的记录。我们的站点已经成为与阿司匹林（LIPS-A）的肺损伤预防试验协调中心，在许多方面，它是花瓣网络所设想的研究类型的原型。因此，理想情况下，我们可以创建一个非常高性能的花瓣临床中心，并为网络领导和科学方向做出贡献。 我们还提交了两项建议，供花瓣网络进行临床研究。这两项研究均基于我们机​​构的强大初步数据。第一个研究将 检查美伐伐汀在综合征发育风险的患者中防止ARDS发育的能力。虽然他汀类药物以前已被用于治疗ARDS的治疗方法，但有大量证据表明，它们可能更有效地作为预防策略。这项研究以我们作为LIPSA研究的临床协调中心的成功为基础。我们提出的第二项研究将测试使用个性化生理学的能力，即使用食道气球测量的患者自身的胸膜压力，以设定既定ARDS患者的阳性末期 - 呼吸压力水平。该提案将支持这种有希望的方式的第三阶段试验。 参与该建议的研究人员的专业知识和经验将使BIDMC临床站点能够为花瓣网络的科学成功做出重大贡献。