Impact of Acute Kidney Injury on Kidney Disease Progression

描述（由申请人提供）：2008年，NIDDK启动了急性肾损伤评估、系列评价和后续后遗症（ASSESS-AKI）研究，该研究在参与临床中心（PCC）前瞻性招募患有和不患有急性肾损伤（阿基）的成人和儿童。该研究的目的是定义阿基的自然史;评估阿基的存在和严重程度对肾脏、心血管和其他临床和以患者为中心的结局的影响;并确定阿基发作后不良事件的预测因素。ASSESS-阿基PCC代表了广泛的临床环境，从心胸外科到重症监护病房，再到地理位置多样化的研究联盟中的综合医院楼层。拟议的ASSESS-AKI-第2阶段将延长随访至2018年9月30日。它将提供一个独特的机会，通过对患有和不患有初始阿基的匹配参与者队列进行长期前瞻性随访，利用ASSESS-AKI-I期的现有努力和成功，以获得各种临床结局， 将支持实现新的科学目标。随附申请是代表范德比尔特大学医学中心PCC对RFA-DK-12-509“急性肾损伤（ASSESS-AKI）研究（U 01）评估、系列评价和后续后遗症的继续有限竞争”的回应。参与PCC的研究中心和数据协调中心要解决的六个具体目标是：目标1）将高比例的ASSESS-AKI参与者重新入组II期;目标2）在ASSESS-AKI参与者中保持出色的保留率、数据质量和结局确定水平;目的3）评估阿基与心肌缺血、纤维化和内皮功能障碍标志物之间的相关性，这些标志物是阿基患者心血管风险增加的潜在因素;目的5）采用无偏倚的蛋白质组学技术来鉴定在短暂性阿基发作后3个月时的新的尿蛋白生物标志物，其鉴定处于进行性肾功能不全风险中的患者;和目标6）促进和支持在ASSESS-AKI中进行辅助研究，包括与更广泛的肾脏学研究界合作。通过PCC的持续参与，ASSESS-AKI-Phase 2将成为无与伦比的资源，将扩展与阿基自然史相关的科学以及阿基对CKD、心血管疾病、生存率、生活质量、功能状态和其他重要结局的发展和进展的影响。

DESCRIPTION (provided by applicant): 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 Vanderbilt University Medical Center 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.