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

描述（由申请方提供）：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。该提案的目的是在新英格兰建立一个创新的多学科临床研究联盟，以促进NHLBI PETAL网络的研究。我们将该临床中心命名为急性肺损伤组新英格兰（ALIGNE）。我们的研究人员在重症监护研究方面拥有丰富的经验。主要研究者（PI）Jay Steingrub博士是一名重症监护医师，目前是位于马萨诸塞州斯普林菲尔德的Baystate临床中心的PI和高效ARDS网络临床中心的负责人。主要合作研究者Peter Hou博士是马萨诸塞州波士顿布里格姆妇女医院的急诊医学和重症监护医生。ALIGN临床中心（CC）的主要地点将是Baystate医学中心（BMC），塔夫茨大学医学院的西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网络进行临床试验。这四家医院是三级转诊中心，在马萨诸塞州的三个地点和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（斯普林菲尔德，马萨诸塞州），布里格姆和妇女医院（波士顿，马萨诸塞州），塔夫茨医疗中心（波士顿，马萨诸塞州）和缅因州医疗中心（波特兰，ME），塔夫茨大学医学院的教学附属机构。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。这些研究中心的研究者和协调员积极参与临床研究，许多研究者在研究设计和实施中发挥领导作用。他们的专业知识和创新技能将用于PETAL网络，以探索ARDS的预防和治疗方式。我们提出的两项临床试验方案代表了这些研究者的合作努力，考虑到ALIGNE内的急诊科年度总就诊人数超过275，000人，每年有超过15，000人入住ICU，以及超过1，000例需要机械通气的肺炎病例，这四家医院招募的研究受试者可能会超过最低预期。获得一个大的招募库是至关重要的，以获得所需的样本量，以权力复杂的研究，以预防和治疗ARDS。这些医院所服务的社区和招募的受试者在民族、种族和社会经济方面各不相同。该联盟将共同努力优化研究流程，以筛选，招募和保留危重患者的招募人群。我们将专注于我们的临床研究人员和协调员在重症监护研究的各个方面的大量专业知识，以及他们对PETAL网络试验的预期贡献。我们建议的CC将在参与机构中涉及多个学科，包括重症监护医学，急诊医学，肺部疾病，医院医学，呼吸治疗和护理，并将维持PETAL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.