Impact of Acute Kidney Injury on Kidney Disease Progression

描述(由申请人提供)：2008年，NIDDK发起了急性肾损伤的评估、系列评估和后续后遗症(EASSISH-AKI)研究，该研究预期在参与的临床中心(PCC)招募患有和不患有急性肾脏损伤(AKI)的成人和儿童。这项研究的目标是确定AKI的自然历史；评估AKI的存在和严重程度对肾脏、心血管和其他以临床和患者为中心的结局的影响；并确定AKI发作后不良事件的预测因素。评估-AKI PCCs代表了广泛的临床环境，从心胸手术到重症监护病房，再到地理上不同的研究联盟中的普通医院楼层。拟议的评估-AKI-阶段2将延长后续行动至2018年9月30日。它将提供一个独特的机会，通过对匹配的有和没有初始AKI的参与者队列进行长期前瞻性跟踪，利用评估-AKI-阶段1的现有努力和成功，获得各种临床结果 将支持解决新的科学目标。所附申请是代表范德比尔特大学医学中心PCC对RFA-DK-12-509“急性肾损伤评估、系列评估及后续后遗症研究(U01)的有限竞争”做出的回应。参与的PCC站点和数据协调中心要解决的六个具体目标是：目标1)重新登记高比例的评估-AKI参与者进入第二阶段；目标2)在评估-AKI参与者中保持突出的保留、数据质量和结果确定水平；目标3)评估AKI与心肌缺血、纤维化和内皮功能障碍的标记物之间的关联，作为AKI患者过度心血管风险的潜在贡献者；目的4)研究AKI对评估-AKI参与者未来代谢紊乱发展的影响；目的5)利用无偏见的蛋白质组学技术，在短暂性急性肾损伤发作后3个月识别新的尿蛋白生物标志物，以确定进行性肾功能障碍的风险；以及目的6)促进和支持在评估急性肾功能衰竭中进行辅助研究，包括与更广泛的肾脏病研究社区的合作。通过PCCs的持续参与，评估-AKI-阶段2将成为一个无与伦比的资源，将扩大与AKI自然历史以及AKI对慢性肾脏病、心血管疾病、存活率、生活质量、功能状态和其他重要结果的发展和进展的影响相关的科学。

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.