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: 8143961
• 负责人: Vernon M Chinchilli
• 金额: $ 20万
• 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 2013-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8143961
• 关键词: Acute; Acute Renal Failure with Renal Papillary Necrosis; Address; Advisory Committees; Archives; Biological; Bypass; Cardiac; Certification; Clinical; Clinical Research; Code; Communication; Complex; Creatinine; Data; Data Analyses; Data Collection; Data Coordinating Center; Data Reporting; Databases; Development; Doctor of Philosophy; Eligibility Determination; Functional disorder; Funding; General Population; Health; Health Care Costs; Health Professional; Health Sciences; Hospitalization; Hospitals; Human; Image; Individual; Information Dissemination; Informed Consent; Institutes; Internet; Kidney; Kidney Failure; Laboratory Study; Leadership; Letters; Long-Term Effects; Lung; Manuals; Measures; Medicine; Methods; Minor; Monitor; Morbidity - disease rate; National Institute of Diabetes and Digestive and Kidney Diseases; Natural History; Nephrology; Nervous System Physiology; Office of Administrative Management; Online Systems; Outcome; Patients; Pennsylvania; Pharmaceutical Preparations; Phase; Procedures; Process; Protocols documentation; Public Health; Publications; Quality Control; Renal function; Reporting; Research; Research Design; Research Personnel; Resources; Role; Safety; Sample Size; Sampling; Sampling Studies; Scheme; Secure; Sepsis; Serum; Shipping; Ships; Site Visit; Specimen; Staging; Statistical Data Interpretation; System; Time; TimeLine; Training; United States National Institutes of Health; Universities; Update; Work; Writing; base; cohort; college; computer network; computerized; data exchange; data management; design; editorial; health science research; meetings; member; mortality; operation; organizational structure; outcome forecast; professor; protocol development; quality assurance; repository; response; sample collection; secondary outcome; symposium; web site

DESCRIPTION (provided by applicant): 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.

描述（由申请人提供）： 急性肾损伤（阿基）发生在各种情况下，并表现出一系列临床表现，从血清肌酐的最小升高到无尿肾衰竭。虽然长期以来，人们一直认为严重急性肾功能不全与严重预后相关，但现在很清楚，即使是轻微的、通常未被识别的急性肾功能不全程度，也会导致发病率、死亡率、住院期间和住院后资源利用率和医疗保健成本增加。我们对人类阿基的理解仍存在几个关键缺陷：（1）很少有研究检查阿基的长期结局;（2）阿基对长期肾功能和死亡率有不良影响;（3）阿基可能对肺、心脏和神经功能有长期影响;（4）没有可靠的标志物来预测预后或指导治疗。为了应对这些缺陷，美国国立卫生研究院（NIH）宣布其意图（RFA DK-07- 009）建立急性肾损伤自然史联盟（联盟或NHAKIC）。该联盟的主要目的是在急性肾损伤（阿基）患者完成疾病的急性期后随访其自然史，并与同期相关对照患者进行比较。该联盟将由NIH、三到五个参与临床中心（PCC）和一个数据协调中心（DCC）组成。联合会将设立一个指导委员会，作为制定和指导联合会活动的主要理事机构。科学咨询委员会（SAC）是一个独立的委员会，将监测和监督该联盟。宾夕法尼亚州立大学医学院的公共卫生科学系（DPHS）和医学系（肾脏科）提议担任该联盟的DCC。发展协调委员会将在研究的所有阶段发挥中心作用，从设计和发展到执行、分析和传播结果。本申请的具体目的如下：（1）为所有研究提供统计和数据分析专业知识，包括统计设计和样本量估计;（2）建立和管理计算机化数据，如数字数据和肾脏和心脏成像数据;建立和管理通信系统;（3）为PCC提供科学协调，包括与联盟研究者合作制定和实施方案，为每个方案格式化数据收集表格，准备和领导培训课程，建立联合体程序的认证标准，并编写操作手册;（4）建立、维护和监督分包合同;（5）与NIDDK生物样品储存库合作;（6）提供项目管理和行政支持;（7）提供招聘支持。