Biomarkers and the Potential Role in Clinical Trials of Acute Kidney Injury: Consensus Report of Acute Dialysis Quality Initiative XIX

Abstract

Biomarkers play important roles in clinical practices including diagnosis and treatment selection. With regard to acute kidney injury (AKI), the use of biomarkers to guide clinical trials is very promising. The committee of the 19th Acute Dialysis Quality Initiative (ADQI) conference met in April 2017 and discussed the integration of biomarkers within clinical trials of acute kidney injury. Consensus had been reached for the significant benefits of integration of biomarkers in clinical trials as well as some potential limitations. Authors concluded the potential role of biomarkers from risk stratification to identification of AKI as well as to monitor therapeutic effects. The group also concluded that biomarkers included within clinical trails could provide both sensitivity and specificity to facilitate trial design. Then the group discussed the role of biomarkers within the PICO (Patient, Intervention, Comparator, Outcome) framework, including the use of biomarkers in patient selection, intervention guidance, comparator and end-point decision. Finally, the committee concluded both the benefits and potential drawbacks of implementing biomarkers in clinical trials of acute kidney injury.