The Wake Forest Clinical Center Investigators will collaborate with and contribute to the goals and operations of the Wake Forest Clinical Center (WFCC), other Clinical Centers (CC) within the PETAL Network, the Clinical Coordinating Center (CCC) and NHLBI. The work proposed will organize and manage experienced personnel with expertise and leadership in the management of patients with and at risk for ALI including critical care, trauma, emergency general surgery and emergency medicine, for the purposes of fulfilling the RFA's request to support research in this patient population. The WFCC will be readily able to meet the long-term objectives and specific aims of the RFA by inclusion of 4 separate, outstanding research institutions with active Emergency Medicine and ICU research capabilities. The WFCC sites include: Wake Forest University Health Sciences (WFUHS), the University of Virginia Health System (UVaHS), the Moses Cone Health Systems (MCHS)) and the Virginia Commonwealth Health System (VCUHS). The WFCC will work to further develop and support PETAL protocols for clinical trials that will impact the outcome of patients at risk fo and with established ALI. Within the application, we propose 2 innovative protocols (the Vitamin C to prevent lung injury and a novel post-hospital discharge communication intervention to reduce hospital readmissions in Survivors of ALI/ARDs) for consideration by the Steering Committee, and commit our support to all active protocols selected during the course of the proposed funding period. The track record of WFCC's performance in the ARDSnetwork I and II demonstrated an enrollment of subjects above our predictions. Importantly, the WFCC, now with a 4th new site, is again well positioned to meet or exceed the enrollment requirements of 40 subjects at risk for ALI or with established ALI/ARDS per year over the 5.5 year Trial enrollment period for a minimum total of 220 patients enrolled over the full duration of the grant's period. The enrollment objective will include recognition of the need to address the distribution of enrolled subjects within important demographic groups.

U01HL123027

2014-06-17

2021-04-30