Acute Lung Injury Group New England Program to Support PETAL Network Research

描述(由申请人提供)：急性呼吸窘迫综合征(ARDS)仍然是危重患者死亡和发病的重要原因。这项建议的目标是在新英格兰发展一个创新的多学科临床研究联盟，以促进NHLBI Petal网络的研究。我们已将该临床中心命名为新英格兰急性肺损伤组织(ALIGNE)。我们的研究人员在重症监护研究方面拥有丰富的经验。首席研究员Jay Steingrub博士是一名危重护理医生，目前是首席研究员兼位于马萨诸塞州斯普林菲尔德的高效ARDS网络临床中心--贝州临床中心的负责人。主要合作调查员Peter Hou博士是马萨诸塞州波士顿布里格姆妇女医院的急诊内科和重症监护内科医生。Aligne临床中心(CC)的主要地点将是贝州医学中心(BMC)、塔夫茨大学医学院的西部校区及其最大的临床培训地点。Aligne CC的研究人员提出了一个由四个医疗中心组成的小组，为Petal Network进行临床试验。这四家医院是第三转诊中心，在马萨诸塞州的三个地点和缅因州波特兰的一个地点为大量患者提供服务。这些医疗中心包括贝州医疗中心(马萨诸塞州斯普林菲尔德)、布里格姆和妇女医院(马萨诸塞州波士顿)、塔夫茨医疗中心(马萨诸塞州波士顿)和缅因州医疗中心(缅因州波特兰)，后者是塔夫茨大学医学院的附属教学机构。这个由四个医疗中心组成的联盟已经存在学术和/或研究联系。这些地点的研究人员和协调员积极参与临床研究，许多研究人员在研究设计和实施方面发挥着领导作用。他们的专门知识和创新技能将用于PEATAL网络，以探索ARDS的预防和治疗方式。我们建议的两项临床试验方案代表了这些研究人员在这四家医院招募研究对象的合作努力，可能会超出最低预期，因为ALIGN内的急诊科年就诊总数超过275,000人次，每年有超过15,000名ICU住院患者，以及超过1,000例需要机械通风的肺炎病例。获得大量招募人员对于获得所需的样本量至关重要，这些样本量有助于开展复杂的ARDS预防和治疗研究。这些医院服务的社区和招募的对象在种族、种族和社会经济方面都是不同的。该联盟将共同努力，优化研究流程，以筛选、招募和留住招募的危重患者群体。我们将重点关注我们的临床研究人员和协调员在危重护理研究的各个方面的丰富专业知识，以及他们对PEAL网络试验的预期贡献。我们建议的CC将涉及多个学科，包括重症监护医学、急诊医学、肺部疾病、医院医学、呼吸疗法和护理，并将维持PEATL网络确定的绩效目标。

DESCRIPTION (provided by applicant): Acute respiratory distress syndrome (ARDS) remains a significant cause of mortality and morbidity in critically ill patients. The objective of this proposal is to develop an innovative and multidisciplinary clinical research consortium in New England to facilitate research by the NHLBI PETAL Network. We have named this Clinical Center Acute Lung Injury Group New England (ALIGNE). Our investigators have extensive experience in critical care research. The Principal Investigator (PI), Dr. Jay Steingrub, a critica care physician, is currently PI and leader of a highly productive ARDS Network Clinical Center, Baystate Clinical Center, in Springfield, MA. The key co-Investigator, Dr. Peter Hou, is an Emergency Medicine and critical care physician, at Brigham and Women's Hospital in Boston, MA. The primary site of the ALIGNE Clinical Center (CC) will be Baystate Medical Center (BMC), the Western Campus of Tufts University School of Medicine and its largest clinical training site. The investigators of ALIGNE CC put forward a group of four medical centers to conduct clinical trials for the PETAL Network. The four hospitals are tertiary referral centers, serving large populations of patients at three sites in Massachusetts and one site in Portland, ME. These medical centers include Baystate Medical Center (Springfield, MA), Brigham and Women's Hospital (Boston, MA), Tufts Medical Center (Boston, MA), and Maine Medical Center (Portland, ME), a teaching affiliate of Tufts University School of Medicine. This consortium of four medical centers has preexisting academic and/or research ties. Investigators and coordinators at these sites are active in clinical research, and many investigators have leadership roles in research design and conduct. Their expertise and innovative skills will be put to use for the PETAL Network to explore prevention and treatment modalities of ARDS. The two clinical trial protocols that we propose represent the collaborative efforts of these investigators Recruitment of research subjects at these four hospitals will likely exceed minimum expectations, given that total annual Emergency Department visits within ALIGNE exceed 275,000, with more than 15,000 annual ICU admissions, and more than 1,000 cases of pneumonia requiring mechanical ventilation. Access to a large recruitment pool is crucial for obtaining the sample sizes needed to power sophisticated studies into the prevention and treatment of ARDS. The communities served by these hospitals and the subjects to be recruited are diverse ethnically, racially, and socioeconomically. This consortium will work together to optimize research processes to screen, enroll, and retain a recruited population of critically ill patients. We will focus on the considerable expertise of our clinical researchers and coordinators in all aspects of critical care research, and their anticipated contribution to PETAL Network trials. Our proposed CC will engage multiple disciplines including Critical Care Medicine, Emergency Medicine, Pulmonary Diseases, Hospital Medicine, Respiratory Therapy, and Nursing at the participating institutions and will sustain performance goals determined by the PETAL Network.