The Assessment, Serial Evaluation, and Subsequent Sequelae of Acute Kidney Injury (ASSESS-AKI) Study: Design and Methods

Alan S Go; Chirag R Parikh; T Alp Ikizler; Steven Coca; Edward D Siew; Vernon M Chinchilli; Chi-yuan Hsu; Amit X Garg; Michael Zappitelli; Kathleen D Liu; W Brian Reeves; Nasrollah Ghahramani; Prasad Devarajan; Georgia Brown Faulkner; Thida C Tan; Paul L Kimmel; Paul Eggers; John B Stokes


BMC Nephrology 

In This Article


As currently defined, acute kidney injury (AKI) refers to a sudden decrease in kidney function as measured by changes in serum creatinine concentration and/or urine output. This phenomenon has been best studied among hospitalized patients and is associated with a high risk (>30%) of short-term mortality in severe cases.[1] The importance of AKI as a clinical and public health problem is underscored by recent studies showing a rising incidence in the U.S. over the past several decades.[2,3]

The vast majority of published studies on AKI have focused primarily on clinical outcomes that occur during the index hospitalization complicated by AKI.[4–8] In 2005, the American Society of Nephrology Renal Research Report listed as a "critically important knowledge gap" studies addressing "long-term outcomes" after an episode of AKI.[1] Recently, several studies have attempted to examine the impact of hospital-acquired AKI on longer-term outcomes, including the risk of development and acceleration of chronic kidney disease (CKD), end-stage renal disease (ESRD), and death.[9–14] However, many existing studies have important methodological challenges that hamper their ability to determine the independent contribution of AKI to these outcomes. These include retrospective study designs, suboptimal quantification of severity of baseline CKD and severity of AKI, ascertainment of clinical outcomes based on data collected as part of routine clinical care and limited ascertainment of important confounding variables. Consequently, there has been a growing appreciation of the need to more rigorously address this question.

In 2007, the National Institute of Diabetes, Digestive and Kidney Diseases (NIDDK) released an Request For Applications (DK-07-009 "Ancillary Studies in the Natural History of Acute Kidney Injury") to create a multi-center research consortium to address these knowledge gaps by expanding our understanding of the natural history of patients suffering from AKI. The Assessment, Serial Evaluation and Subsequent Sequelae of Acute Kidney Injury (ASSSESS-AKI) Consortium was established in 2008 to compare prospectively differences in the occurrence of renal and cardiovascular outcomes and death within a diverse, matched cohort of patients with and without AKI. The overall goals of ASSESS-AKI are to:

  • Establish a diverse prospective, parallel, matched cohort of adults and children with and without AKI.

  • Characterize the short-term and long-term natural history of AKI based on current serum creatinine-based diagnostic criteria.

  • Evaluate the incremental utility of novel blood and urine biomarkers to refine the diagnosis and prognosis of AKI.

  • Develop a prognostic risk model that integrates patient characteristics and biomarkers to help inform providers and patients about the risks of adverse events after an episode of AKI.

  • Identify the subset of high-risk patients who could be targeted for future interventional clinical trials to improve outcomes after an episode of AKI.

The ASSESS-AKI Study will leverage ongoing studies involving patients undergoing cardiac surgery or in the intensive care unit and expand the study population to include a more general hospitalized population to provide a broadly representative study of the natural history of AKI.


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