Collaborative Pediatric Critical Care Research Network - Clinical Site

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ABSTRACT – University of Colorado Denver With our participation in this iteration of the Collaborative Pediatric Critical Care Research Network (CPCCRN), we contributed to a series of discoveries that enhanced our understanding of disease processes and resulted in a multitude of potentially effective treatments for critically ill and injured children that require definitive evaluation in clinical trials. There continues to be tremendous need for a collaborative research network in pediatric critical care to facilitate the swift and effective translation of scientific and technologic discoveries into clinical advances. Access to appropriate patients and expertise in the execution of clinical trials must be linked to scientists and laboratories working within and across disciplines at the cutting edge of scientific advancement. At the University of Colorado Denver (UCD) and Children’s Hospital Colorado (CHCO), we have a long history of successful collaborative basic, translational, and clinical science programs focused on pediatric critical illness and injury. We will provide several unique areas of strength to the CPCCRN, including: 1) a distinctive multidisciplinary team of collaborative researchers with specific expertise in mechanistic investigations of cardiovascular and pulmonary diseases, 2) a proven and successful track record as a clinical site in CPCCRN, 3) expertise with pediatric clinical trials execution, including innovative programs to enhance positive research culture among clinical staff and participation among patients and families, 4) a 7-state catchment area with high volumes of critically ill and injured children, 5) an in-house rehabilitation program and extensive outpatient outreach program capable of providing follow-up care to nearly all our critically ill patients, and 6) a dynamic partnership with the Children’s Hospital Colorado Research Institute and Colorado Clinical Translational Science Institute to provide extensive research resources. Our ancillary site, Arkansas Children’s Hospital (ACH) provides 1) experience with pediatric clinical trials execution, including previous successful membership in CPCCRN 2) provision of care to nearly all of the critically ill children from the State of Arkansas and a 4-state catchment area, 3) representation of an Institutional Development Award (IDeA) state (historically received low levels of NIH support) and involving their unique populations (rural, Marshallese, and medically underserved communities) in the NIH mission, and 4) a rich partnership with the ACH Research Institute and University of Arkansas Clinical Translational Science Award to provide comprehensive research resources. Utilizing these assets, we will augment the contributions of CPCCRN to the care of critically ill children through rigorous clinical trial execution, innovative translational and clinical trial proposals, participation in CPCCRN leadership committees, and training the next generation of pediatric critical care researchers. The proposed trial of “Personalized Immunomodulation in Sepsis induced Multiple Organ Dysfunction Syndrome” is an incredibly innovative approach that moves beyond a “one therapy for all” paradigm to an individualized therapeutic approach that will dramatically improve outcomes for children with sepsis. We are enthusiastic and committed to participate in this project with the new 24-site CPCCRN.