The Pittsburgh Scientific and Data Research Center for the COPE-AKI Consortium (Pitt-SDRC)

摘要 急性肾脏损伤(AKI)和慢性肾脏疾病(CKD)是相互关联的综合征 它们相互影响。慢性肾脏病是AKI的危险因素，而AKI对 慢性肾脏病、终末期肾病(ESRD)、心血管症状、 和死亡，更不用说反复发作的AKI和与健康相关的生活质量受损 (HRQOL)。AKI住院后的护理流程被发现是次优的， 缺乏连续性的护理、延迟的随访和不理想的用药管理 加剧了不利后果的风险。此外，最佳药物治疗，如 阻断肾素-血管紧张素-醛固酮系统(RAAS)或钠-葡萄糖共转运体 类型2(SGLT2)尚未定义。急性肾损伤患者的门诊护理 (COPE-AKI)联盟将解决有关最佳 中度(2期)或重度(3期)AKI患者的治疗。这个 COPE-AKI联盟的目标将是开发和测试干预措施，以优化 护理过程并确定关键的药理学和非药理学干预措施 减少这些高危患者的发病率。临床试验和数据中心 匹兹堡大学的协调中心(CCDC)已做好充分准备，将成为科学和 COPE-AKI联盟的数据研究中心(SDRC)。我们的多学科 调查小组有合作的历史、丰富的经验和专门知识，包括 在急慢性肾脏疾病、危重和转化性护理、药物治疗方面的专业知识 管理、临床试验设计、远程医疗、临床和数据协调、项目 管理支持、生物统计学、患者报告结果的测量、健康 服务研究和患者参与。我们的目标是成为科学和数据 COPE-AKI联盟研究中心。具体地说，我们将1)建立一个高效和 设计联合体研究的严格程序，包括协议制定和 调整现有的网上数据收集系统；2)提供全面的专门知识 用于联合体内的数据管理和分析；以及3)提供项目协调 并在研究的所有阶段提供行政支持。

ABSTRACT Acute kidney injury (AKI) and chronic kidney disease (CKD) are “interconnected” syndromes in which each influences the other. CKD is a risk factor for AKI and AKI contributes to the development or progression of CKD, end-stage renal disease (ESRD), cardiovascular symptoms, and death, not to mention recurrent AKI episodes and impaired health-related quality of life (HRQoL). Processes of care after AKI hospitalization have been found to be suboptimal, with lack of continuity of care, delayed follow-up and suboptimal medication management exacerbating the risks of adverse outcomes. In addition, optimal pharmacologic therapy, such as blockade of the renin-angiotensin-aldosterone system (RAAS) or sodium-glucose cotransporter type 2 (SGLT2), has not been defined. The Caring for OutPatiEnts after Acute Kidney Injury (COPE-AKI) Consortium will address these important gaps in knowledge of optimal management of patients surviving an episode of moderate (stage 2) or severe (stage 3) AKI. The goal of the COPE-AKI Consortium will be to develop and test interventions to optimize processes of care and identify key pharmacologic and non-pharmacologic interventions to reduce morbidity among these high-risk patients. The Center for Clinical Trials & Data Coordination (CCDC) at the University of Pittsburgh is well poised to serve as the Scientific and Data Research Center (SDRC) for the COPE-AKI Consortium. Our multidisciplinary investigative team has a history of collaboration, wealth of experience and expertise, including expertise in acute and chronic kidney disease, critical and translational care, medication management, design of clinical trials, telehealth, clinical and data coordination, project administration support, biostatistics, measurement of patient-reported outcomes, health services research and patient engagement. Our goal is to serve as the Scientific and Data Research Center for the COPE-AKI Consortium. Specifically, we will 1) establish an efficient and rigorous process for designing the Consortium study, including protocol development and adaptation of an existing web-based data collection system; 2) provide comprehensive expertise for data management and analysis within the Consortium; and 3) provide program coordination and administrative support throughout all phases of the study.