Collaborative Pediatric Critical Care Research Network - Clinical Site

PROJECT ABSTRACT - University of California Consortium The University of California, San Francisco (UCSF) Benioff Children's Hospital has been a Clinical Site in the Eunice Kennedy Shriver National Institutes of Child Health and Development (NICHD) Collaborative Pediatric Critical Care Research Network (CPCCRN) since 2014 (3rd cycle) and is enthusiastic about participating as a Clinical Hub in the newly organized and expanded network. During the 3rd cycle, Dr Anil Sapru (original PI) relocated to University of California, Los Angeles (UCLA) and UCLA joined UCSF as a consortium site. More recently UCSF has affiliated with the former Children's Hospital Oakland resulting in the new Benioff Children's Hospitals at San Francisco (BCHSF) and Oakland (BCHO). Thus, BCHSF and BCHO, along with UCLA, will comprise a clinical consortium or hub site in the present site application. We will work closely with our ancillary site, University of California, Davis Children's Hospital. In combination with this partner, our site will provide access to 104 PICU beds with approximately 4500 annual admissions, enabling us to participate fully in the “Personalized Immunomodulation in Sepsis-induced MODS” trial described in the Overall Component of this application. Our site proposal has three specific aims: Specific Aim 1. Actively collaborate in implementation of CPCCRN, including participation on the Steering Committee and other committees, attendance at meetings, facilitating contracting with the Data Coordinating Center, and complying with the standard operating procedures and performance expectations of the network. Specific Aim 2. Provide opportunities for young investigators to participate in CPCCRN meetings, committees, or trial implementation, with the goal of developing these talented individuals into fundable clinician scientists. Specific Aim 3. Implement the Personalized Immunomodulation in Sepsis-induced MODS trial, including enrollment of patients by trained research staff, adhering to the study protocol, prompt data entry, and full compliance with Good Clinical Practice (GCP) and other regulatory requirements.