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.

Public Health Relevance

To participate in the NHLBI PETAL Network, Baystate Medical Center has developed an innovative and multidisciplinary clinical research consortium, referred to as the Acute Lung Injury Group New England (ALIGNE) Clinical Center (CC). The PI of the new CC, Dr. Jay Steingrub, has created a partnership involving academic medical schools and community teaching hospitals to accelerate the development of interventions for patients at high risk for, or with, early ARDS. Recruitment of research subjects at ALIGNE hospitals will likely exceed minimum expectations given that the Baystate Medical Center research group will provide invaluable resources and a model through its expertise in having instituted embedded processes and procedures for screening, recruitment, and retention of patients for both ARDS Network 1 and 2.

National Institute of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Research Project--Cooperative Agreements (U01)
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Special Emphasis Panel (ZHL1-CSR-S (F1))
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Harabin, Andrea L
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Baystate Medical Center
United States
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