Data Coordinating Center for the Natural History of AKI Consortium

AKI 联盟自然历史数据协调中心

• 批准号: 8737229
• 负责人: Vernon M Chinchilli
• 金额: $ 90.76万
• 依托单位: PENNSYLVANIA STATE UNIV HERSHEY MED CTR
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-09-01 至 2018-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8737229
• 关键词: Acute Renal Failure with Renal Papillary Necrosis; Address; Adult; Adverse event; Ancillary Study; Archives; Biological Markers; Biotechnology; California; Cardiac; Cardiovascular Diseases; Cardiovascular system; Certification; Child; Clinical; Code; Cognitive; Collaborations; Communication; Communities; Data; Data Analyses; Data Coordinating Center; Data Quality; Data Reporting; Databases; Development; Disease Outcome; Electrocardiogram; Enrollment; Equipment; Evaluation; Event; Fibrosis; Floor; Functional disorder; Funding; Future; General Hospitals; Goals; Health Sciences; Hospitalization; Informed Consent; Intensive Care Units; Internet; Ischemia; Kidney; Laboratories; Leadership; Measures; Metabolic; National Institute of Diabetes and Digestive and Kidney Diseases; Natural History; Nephrology; Office of Administrative Management; Operative Surgical Procedures; Outcome; Participant; Patient-Focused Outcomes; Patients; Pennsylvania; Pharmacologic Substance; Phase; Process; Proteins; Proteomics; Protocols documentation; Public Health; Publications; Quality of life; Reading; Research; Research Design; Research Personnel; Resources; Risk; Sample Size; Sampling; Sampling Studies; San Francisco; Scheme; Science; Secure; Severities; Shipping; Ships; Site; Site Visit; Statistical Data Interpretation; System; Techniques; TimeLine; Universities; Vendor; Washington; Work; cardiovascular risk factor; cohort; computer network; computerized; editorial; endothelial dysfunction; follow-up; functional outcomes; functional status; meetings; mortality; novel; prospective; public health relevance; quality assurance; repository; response; success; symposium; urinary

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 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.

描述（由申请人提供）：2008 年，NIDDK 启动了急性肾损伤的评估、系列评估和后续后遗症 (ASSESS-AKI) 研究，该研究前瞻性地招募患有或不患有急性肾损伤 (AKI) 的成人和儿童参与研究。临床中心（PCC）。该研究的目标是定义 AKI 的自然史；评估 AKI 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果的影响；并确定 AKI 发作后不良事件的预测因素。 ASSESS-AKI PCC 代表了广泛的临床环境，从心胸外科到重症监护病房，再到地域不同的研究联盟中的综合医院楼层。拟议的 ASSESS-AKI-第 2 阶段将把后续行动延长至 2018 年 9 月 30 日。它将提供一个独特的机会，通过对匹配的长期前瞻性后续行动来利用 ASSESS-AKI-第 1 阶段的现有努力和成功。具有或不具有初始 AKI 的参与者队列的各种临床结果 将支持解决新的科学目标。随附的申请是为了响应 RFA-DK-12-509“急性肾损伤 (ASSESS-AKI) 研究 (U01) 继续评估、系列评估和后续后遗症的有限竞争”，代表北加州凯撒医疗机构/加州大学旧金山分校 PCC。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) 将高比例的 ASSESS-AKI 参与者重新纳入第 2 阶段；目标 2) 保持 ASSESS-AKI 参与者出色的保留率、数据质量和结果确定水平；目标 3) 评估 AKI 与心脏缺血、纤维化和内皮功能障碍标志物之间的关联，这些标志物是 AKI 患者心血管风险过高的潜在因素；目标 4) 研究 AKI 对 ASSESS-AKI 参与者未来代谢紊乱发展的影响；目标 5) 采用公正的蛋白质组学技术来鉴定短暂性 AKI 发作后 3 个月时的新型尿蛋白生物标志物，以识别有进展性肾功能障碍风险的患者；目标 6) 促进和支持 ASSESS-AKI 辅助研究的开展，包括与更广泛的肾病学研究界的合作。通过 PCC 的持续参与，ASSESS-AKI-第 2 阶段将成为无与伦比的资源，将扩展与 AKI 自然史相关的科学以及 AKI 对 CKD、心血管疾病、生存、质量的发展和进展的影响生命、功能状态和其他重要结果。