Acute kidney injury (AKI) occurs in a variety of settings and presents with a spectrum of clinical manifestations ranging from a minimal elevation in serum creatinine to anuric renal failure. Although severe acute renal dysfunction has long been known to be associated with a grave prognosis, it is now clear that even minor, often unrecognized, degrees of acute renal dysfunction result in increased morbidity, mortality, n-hospital and post-hospitalization resource utilization and health care costs. There remain several critical deficits in our understanding of AKI in humans: (1) few studies have examined the long-term outcomes of AKI;(2) AKI has an adverse impact on long-term renal function and mortality;(3) AKI may have long-term effects on pulmonary, cardiac and neurologic function;(4) there are no reliable markers to predict prognosis or guide management. In response to these deficits, the National Institutes of Health (NIH) announced its intentions (RFA DK-07- 009) to establish the Natural History of Acute Kidney Injury Consortium (Consortium or NHAKIC). The primary objective of the Consortium is to follow the natural history of patients with Acute Kidney Injury (AKI) after they finish the acute phase of their illness and compare with concurrent relevant control patients. The Consortium will consist of a partnership among the NIH, three to five Participating Clinical Centers (PCCs), and one Data Coordinating Center (DCC). The Consortium will have a Steering Committee (SC), which will be the main governing body to develop and direct its activities. A Scientific Advisory Committee (SAC), an independent committee, will monitor and oversee the Consortium. The Department of Public Health Sciences (DPHS) and the Department of Medicine (Division of Nephrology) at The Pennsylvania State University College of Medicine propose to serve as the DCC for the Consortium. The DCC will have a central role in all stages of the studies, from design and development to implementation, analysis, and dissemination of results.
The specific aims of this application are as follows: (1) provide statistical and data analysis expertise for all studies, including statistical design and sample size estimation;(2) establish and manage the computerized data, such as numeric data and kidney and cardiac imaging data;establish and manage a communication systems;(3) provide scientific coordination for the PCCs that includes collaborating with the Consortium investigators on protocol development and implementation, formatting data collection forms for each protocol, preparing and leading training sessions, establishing certification criteria for Consortium procedures, and writing the manuals of operations;(4) establish, maintain, and provide oversight to subcontracts;(5) collaborate with the NIDDK Biosamples Repository;(6) provide project management and administrative support;(7) provide recruitment support.
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