In 2008, the NIDDK initiated the Assessment, Serial Evaluation, and Subsequent Sequelae of Acute Kidney Injury (ASSESS-AKI) Study which is prospectively enrolling adults and children with and without acute kidney injury (AKI) at Participating Clinical Centers (PCC). The goals of the study are to define the natural history of AKI;to evaluate the impact of the presence and severity of AKI on renal, cardiovascular and other clinical and patient-centered outcomes;and to identify predictors of adverse events after an episode of AKI. The ASSESS- AKI PCCs represent a broad spectrum of clinical settings ranging from cardiothoracic surgery to intensive care units to general hospital floors in a geographically diverse research consortium. The proposed ASSESS-AKI- Phase 2 will extend follow-up through September 30, 2018. It will offer a unique opportunity to leverage the existing effort and success of ASSESS-AKI-Phase 1 through long-term prospective follow-up of a matched cohort of participants with and without initial AKI for a variety of clinical outcomes that will support addressing novel scientific goals. The enclosed application is in response to RFA-DK-12-509, "Limited Competition for the Continuation of the Assessment, Serial Evaluation, and Subsequent Sequelae of Acute Kidney Injury (ASSESS-AKI) Study (U01)," on behalf of the Kaiser Permanente Northern California/University of California, San Francisco PCC. The six Specific Aims to be addressed by the participating PCC sites and Data Coordinating Center are:
Aim 1) To re-enroll a high percentage of ASSESS-AKI participants into Phase 2;
Aim 2) To maintain outstanding levels of retention, data quality and outcome ascertainment among ASSESS-AKI participants;
Aim 3) To evaluate the association between AKI and markers of cardiac ischemia, fibrosis, and endothelial dysfunction as potential contributors to excess cardiovascular risk in patients with AKI;
Aim 4) To examine the impact of AKI on the future development of metabolic disturbances among ASSESS-AKI participants;
Aim 5) To employ unbiased proteomic techniques to identify novel urinary protein biomarkers at 3 months after an episode of transient AKI that identify patients at risk for progressive renal dysfunction;
and Aim 6) To promote and support the conduct of ancillary studies in ASSESS-AKI, including collaboration with the broader nephrology research community. Through the ongoing participation of the PCCs, ASSESS-AKI-Phase 2 will become an unparalleled resource that will expand the science related to AKI natural history as well as the impact of AKI on the development and progression of CKD, cardiovascular disease, survival, quality of life, functional status and other important outcomes.

Public Health Relevance

This project is the continuation of the NIDDK-sponsored Assessment, Serial Evaluation, and Subsequent Sequelae of Acute Kidney Injury (ASSESS-AKI) Study. ASSESS-AKI is a prospective cohort study that will enroll approximately 1500 adults and 100 children with and without acute kidney injury (AKI) at Participating Clinical Centers. The overarching goals of this renewal are to re-enroll a high percentage of ASSESS-AKI participants into Phase 2 while maintaining outstanding levels of retention, data quality and outcome ascertainment among ASSESS-AKI participants to complete the goals of Phase 1. We will also evaluate novel associations between AKI and markers of cardiac ischemia, fibrosis, endothelial dysfunction and metabolic and nutritional disturbances among ASSESS-AKI participants and employ unbiased proteomic techniques to identify novel urinary protein biomarkers at 3 months after an episode of transient AKI that identify patients at risk for progressive renal dysfunction.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project--Cooperative Agreements (U01)
Project #
2U01DK082185-06
Application #
8585723
Study Section
Special Emphasis Panel (ZDK1-GRB-C (M1))
Program Officer
Kimmel, Paul
Project Start
2008-09-01
Project End
2018-06-30
Budget Start
2013-09-19
Budget End
2014-06-30
Support Year
6
Fiscal Year
2013
Total Cost
$476,000
Indirect Cost
$154,510
Name
Yale University
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
043207562
City
New Haven
State
CT
Country
United States
Zip Code
06520
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Coca, Steven G; Garg, Amit X; Swaminathan, Madhav et al. (2013) Preoperative angiotensin-converting enzyme inhibitors and angiotensin receptor blocker use and acute kidney injury in patients undergoing cardiac surgery. Nephrol Dial Transplant 28:2787-99
Jayakumar, Calpurnia; Ranganathan, Punithavathi; Devarajan, Prasad et al. (2013) Semaphorin 3A is a new early diagnostic biomarker of experimental and pediatric acute kidney injury. PLoS One 8:e58446
Perazella, Mark A; Coca, Steven G (2013) Three feasible strategies to minimize kidney injury in 'incipient AKI'. Nat Rev Nephrol 9:484-90

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