Collaborative Pediatric Critical Care Research Network - Clinical Site

PROJECT SUMMARY/ABSTRACT – University of Minnesota The Collaborative Pediatric Critical Care Research Network (CPCCRN) has been critical in building the knowledge base of pediatric critical care medicine. The overall aim of this site proposal is for the University of Minnesota Masonic Children's Hospital (UMMCH), under the leadership of Site Principal Investigator, Marie Steiner, MD, MS, to join this expanded iteration of CPCCRN. UMMCH is a free-standing, quaternary care, academic children's hospital located in Minneapolis, MN, serving children and families across a diverse range of racial, ethnic, and socioeconomic backgrounds. It has a 24-bed mixed medical/surgical and cardiac pediatric intensive care unit and offers the full spectrum of pediatric and surgical subspecialty services. UMMCH has a strong history of clinical research and innovation in conjunction with the resources of the University of Minnesota, the state's land grant university. Pediatric critical care research includes numerous completed and ongoing studies championed by multiple faculty, including the Co-Investigators for this grant. With increasing support from internal and external grants and the development of the Pediatric Device Innovation Center, the Division was third in the Department in launching new studies in 2019, behind Hematology/Oncology and HSCT. Children's Minnesota (Children's) will serve as our Ancillary Site under the leadership of Alberto Orioles, MD. Children's is a not-for-profit, freestanding children's hospital also located in Minneapolis, with a long-standing history of participation in critical care research, including several CPCCRN studies. Together, UMMCH and Children's will provide access to 55 pediatric ICU beds and over 3500 annual admissions, which captures the majority of critically ill children throughout the Upper Midwest and will facilitate participation in large clinical trials. The proposed “Personalized Immunomodulation in Sepsis-Induced Multiple Organ Dysfunction Syndrome (MODS)” trial addresses the hypothesis that immunosuppressed children will benefit from administration of granulocyte macrophage-colony stimulating factor and that children with hyperinflammation will benefit from targeted anti-inflammatory therapy. Benefit will be evaluated in terms of recovery from MODS, as well as short- and long-term health-related quality of life measures. This partnership has the knowledge and skills to successfully complete this trial, including sample collection and processing for immunophenotyping and collection of short- and long-term outcomes. Drs. Steiner and Orioles have the full support of their respective institutions to participate in CPCCRN and to prioritize patient recruitment and accrual to its studies. The institutions are strongly committed to collaboration with CPCCRN sites and the Data Coordinating Center to conduct the proposed and future research. Our clinical center and ancillary site will provide local mentorship for our highly talented young faculty and will support their participation in the central CPCCRN mentoring activities that are described in Section B.3 of the required CPCCRN Network Organizational Structure attachment to the Overall Component of this PL1 application.