Collaborative Pediatric Critical Care Research Network - Clinical Site

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PROJECT SUMMARY/ABSTRACT – Children's Hospital of Michigan The Collaborative Pediatric Critical Care Research Network (CPCCRN) is essential to advancing the science and practice of pediatric critical care medicine. The overall aim of this site proposal is for Children's Hospital of Michigan (CHM), under the leadership of Kathleen Meert, MD, to continue as a clinical site in the new and expanded CPCCRN. Dr. Meert, site-PI for the CPCCRN for the past 15 years, is a pediatric intensivist with a wealth of clinical and translational research experience. Dr. Meert has successfully mentored many junior investigators at CHM and other CPCCRN sites, and produced numerous scientific publications for the CPCCRN. CHM is a free-standing, tertiary care, academic children's hospital located in Detroit, Michigan, that serves children and families with diverse racial, ethnic and socioeconomic backgrounds. Strengths of CHM as a clinical site include the new (2017) Pediatric (PICU) and Cardiac (CICU) intensive care units with a total of 48 beds and over 2,000 admissions annually. CHM offers the full spectrum of pediatric and surgical subspecialty services, and is an American College of Surgeons Level 1 Pediatric Trauma Center and an American Burn Association Pediatric Burn Center. In addition to the resources available at CHM, Spectrum Health DeVos Children's Hospital in Grand Rapids, Michigan, will serve as an Ancillary Site under the leadership of Surender Rajasekaran, MD, MPH. DeVos has a total of 32 ICU beds that include a 24-bed PICU and 8-bed CICU; these units admit approximately 1,500 children annually. Together, CHM and DeVos will provide access to 80 ICU beds and over 3,500 annual admissions, enabling full participation in large randomized controlled trials (RCT). The “Personalized Immunomodulation in Sepsis-Induced Multiple Organ Dysfunction Syndrome (MODS)” trial proposed in this application is a large RCT of personalized, targeted management of immune function in children with sepsis-induced MODS. The trial addresses the hypothesis that immunosuppressed children will benefit from granulocyte macrophage-colony stimulating factor (GM-CSF), and children with hyperinflammation will benefit from targeted anti-inflammatory therapy with anakinra (recombinant IL-1 receptor antagonist) or tocilizumab (IL-6 receptor blocking antibody). Benefit will be evaluated in terms of duration and severity of organ dysfunction, and health-related quality of life and family functioning at 3 and 12 months. Dr. Meert and her research team are thoroughly familiar with the CPCCRN studies on which this trial is based including methods of sample collection and processing for immunophenotyping, dosing and administration of GM-CSF, and collection of short- and long-term sepsis-related outcomes. Dr. Rajasekaran has research expertise in the pathogenetic mechanisms underlying pediatric MODS making him well-suited to conduct this trial. Dr. Meert and Dr. Rajasekaran have the full support of their respective institutions to participate in the CPCCRN, and are strongly committed to collaboration with other CPCCRN sites and the Data Coordinating Center in conducting the proposed research, as well as the inclusion and mentoring of junior investigators in CPCCRN activities.