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Open Access Highly Accessed Study protocol

The assessment, serial evaluation, and subsequent sequelae of acute kidney injury (ASSESS-AKI) study: design and methods

Alan S Go12*, Chirag R Parikh3, T Alp Ikizler4, Steven Coca3, Edward D Siew4, Vernon M Chinchilli5, Chi-yuan Hsu2, Amit X Garg6, Michael Zappitelli7, Kathleen D Liu2, W Brian Reeves5, Nasrollah Ghahramani5, Prasad Devarajan8, Georgia Brown Faulkner5, Thida C Tan1, Paul L Kimmel9, Paul Eggers9, John B Stokes10 and the Assessment Serial Evaluation, and Subsequent Sequelae of Acute Kidney Injury (ASSESS-AKI) Study Investigators

Author Affiliations

1 Kaiser Permanente Northern California, Oakland, CA, USA

2 University of California, San Francisco, San Francisco, CA, USA

3 Yale University, New Haven, CT, USA

4 Vanderbilt University, Nashville, TN, USA

5 Pennsylvania State University, Hershey, PA, USA

6 London Health Sciences Centre, Ontario, Canada

7 Montreal Children's Hospital, Montreal, Canada

8 Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA

9 National Institute of Diabetes, Digestive and Kidney Diseases, Bethesda, MD, USA

10 University of Iowa, Iowa City, IA, USA

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BMC Nephrology 2010, 11:22  doi:10.1186/1471-2369-11-22

Published: 27 August 2010

Abstract

Background

The incidence of acute kidney injury (AKI) has been increasing over time and is associated with a high risk of short-term death. Previous studies on hospital-acquired AKI have important methodological limitations, especially their retrospective study designs and limited ability to control for potential confounding factors.

Methods

The Assessment, Serial Evaluation, and Subsequent Sequelae of Acute Kidney Injury (ASSESS-AKI) Study was established to examine how a hospitalized episode of AKI independently affects the risk of chronic kidney disease development and progression, cardiovascular events, death, and other important patient-centered outcomes. This prospective study will enroll a cohort of 1100 adult participants with a broad range of AKI and matched hospitalized participants without AKI at three Clinical Research Centers, as well as 100 children undergoing cardiac surgery at three Clinical Research Centers. Participants will be followed for up to four years, and will undergo serial evaluation during the index hospitalization, at three months post-hospitalization, and at annual clinic visits, with telephone interviews occurring during the intervening six-month intervals. Biospecimens will be collected at each visit, along with information on lifestyle behaviors, quality of life and functional status, cognitive function, receipt of therapies, interim renal and cardiovascular events, electrocardiography and urinalysis.

Conclusions

ASSESS-AKI will characterize the short-term and long-term natural history of AKI, evaluate the incremental utility of novel blood and urine biomarkers to refine the diagnosis and prognosis of AKI, and identify a subset of high-risk patients who could be targeted for future clinical trials to improve outcomes after AKI.