Clinical Core

Modified Project Summary/Abstract Section: Clinical Core Acute kidney injury (AKI) is a public health concern with direct impact on clinical and patient-centered outcomes, and healthcare resource utilization and policy. Recognizing the paucity of breakthrough discoveries in AKI and the growing burden of this condition, the UAB-UCSD O’Brien Clinical Core (Core A) is designed to reduce the barriers for investigators to conduct effective clinical and translational research by providing a robust infrastructure to promote collaborative projects across pre-clinical, clinical and industry researchers. Core A will provide multifaceted consultation through a customized Project Gateway, access to clinical databases, available biorepositories, and novel bioinformatics and computational technologies such as the U-BRITE and Nightingale collaborative digital workspaces in partnership with the Clinical and Translational Science Awards (CTSA) programs at both institutions for the harmonization and interrogation of big data with a focus on personalized medicine in AKI. Specifically, Core A will facilitate collaborative digital workspaces for electronic health record (EHR) data acquisition, transformation, validation, and interrogation. The overarching goal is to catalyze the translation of bench discoveries to applications that impact human AKI. The Specific Aims are structured as follows. In Aim 1, we will provide access to clinical data of patients at risk for or with AKI and consultation for their use. Specifically, we will provide access to curated clinical data from prior clinical studies hosted by Core A (Aim 1A) and provide access to new harmonized real-world data from the EHR to support epidemiological surveillance of AKI (e.g., AKI incidence, risk factors and outcomes) and novel clinical research, including but not limited to AKI risk-classification, sub-phenotyping, and simulated trials (Aim 1B). In Aim 2, we will provide access to biospecimens of patients at risk for or with AKI and consultation for their use. Specifically, we will provide access to biospecimens from prior studies hosted by Core A (Aim 2A). In Aim 2B we will provide a novel platform to link biospecimens of patients at risk for or with AKI with EHR data. Core A will have dynamic communications and collaborations with the Pre-Clinical Core, the Resource Development Core, and the O’Brien Kidney Consortium. In this U54 application, we will build upon our expertise and established successes demonstrated through our currently funded O’Brien Center P30 award. Given our commitment and expertise, we are confident that Core A will provide innovative resources to the growing research community interested in AKI-related research.