Databases and tools to support Clinical Studies in AKI

To support the design and conduct of clinical research in AKI

1. Core A provides innovative clinical resources to support clinical and translational research in AKI. Firstly, the core provides consulting for study design with appropriate endpoints, selection of biomarker assays (available through Core C), protocol development including case report forms, and training for study personnel to conduct AKI studies. Secondly, the database management system (DBMS) provides the infrastructure, procedures and tools for data management on an open platform that can be customized for future studies and includes lab sample tracking linked to clinical events. Finally, the core provides investigators access to protocols and assays for renal functional measurement which can be coupled with the array of biomarkers available through Bioanalytical Core C to provide investigators a comprehensive tool kit for AKI research.
2. Centralized web-based database management system (DBMS) with standardized clinical data: Core A provides investigators access to the ongoing web-based DBMS that includes core variables that have been standardized and identified as being relevant and necessary for AKI research. The database is designed to be accessible worldwide and is HIPAA compliant. In addition to common data elements to capture patient demographics, sequential clinical and lab data and medications the database has built in risk scores, dialysis procedures and outcomes. It hosts customizable modules for specific settings including parameters relevant for ICU patients, cardiac surgery, contrast nephropathy, cardiac catheterization, drug-induced kidney disease, post AKI Care, and transplant-related AKI. The database has built in event recording, audits and automated query generation and tracking for completeness and can generate randomization schedules. It provides customized summary profiles for patient adjudication. It is complemented by a laboratory sample management system with barcoding and sample tracking.
3.  Established collaborative networks in AKI: Core A has established a large international collaborative network of experienced investigators who are engaged in AKI studies. They represent >40 Centers with a mix of academic and community based settings in Asia, Africa, Europe, North and South America and Australia. Participating centers in this network have been part of the AKI registry and the DIRECT study. The network has facilitated the development of a robust biological sample repository for blood, urine and DNA. For example, the International Safety Adverse Events Consortium (ISAEC) has utilized the Core A network for the DIRECT study designed to collect DNA and biomarker samples from 634 well-characterized adult and pediatric patients with drug-induced kidney disease.