Central Biochemistry Laboratory of the CKiD Consortium

CKiD 联盟中央生物化学实验室

• 批准号: 7901894
• 负责人: GEORGE J SCHWARTZ
• 金额: $ 7.51万
• 依托单位: UNIVERSITY OF ROCHESTER
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-28 至 2011-09-27
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7901894
• 关键词: 25-hydroxyvitamin D; Academic Medical Centers; Advisory Committees; Ancillary Study; Bicarbonates; Biochemical; Biochemistry; Biological Assay; Blood; Cardiovascular Diseases; Cardiovascular system; Carrier Proteins; Child; Chronic Kidney Failure; Clinical; Collaborations; Collection; Creatinine; Data; Data Coordinating Center; Databases; Development; Doctor of Medicine; Electrolytes; Epidemiology; Equation; Fingers; Generations; Glomerular Filtration Rate; Glucose; Goals; Growth; Guidelines; Hair; Health Status; High Pressure Liquid Chromatography; Inflammation; Instruction; Iohexol; Isotopes; Kidney; Kidney Diseases; Laboratories; Leadership; Licensing; Lipids; Manuscripts; Mass Spectrum Analysis; Measurement; Measures; Medical center; Medicine; Methodology; Methods; Nail plate; National Institute of Diabetes and Digestive and Kidney Diseases; Nature; Nephrons; Neurocognition; Online Systems; Paper; Pathology; Plasma; Population; Population Study; Positioning Attribute; Process; Prospective Studies; Proteins; Protocols documentation; Pump; Quality Control; Reagent; Recommendation; Reference Standards; Renal function; Reporting; Research; Research Personnel; Sampling; Scientist; Serum; Site; Specimen; Standardization; Time; Training; United States National Institutes of Health; Universities; Update; Urine; Visit; Vitamin D; Work; abstracting; base; clinical research site; cost; improved; meetings; pediatric department; post gamma-globulins; programs; repository; skeletal; success; symposium; tool

The Central Biochemistry Laboratory (CBL) has assumed a key leadership position in the renewal of the Prospective Study of Chronic Kidney Disease in Children (CKiD). The CBL is responsible for providing participating clinical sites with the reagents, supplies, shippers and protocols needed for performing iohexol- based glomerular filtration rate (GFR) studies and transporting blood to the University of Rochester laboratory for analysis of key kidney determinants, including Cr, BUN, electrolytes, glucose, Ca, P, intact PTH, vitamin D, wrCRP, lipid screen, and cystatin C. Similarly, urine is collected and transported for protein, creatinine, and microalbumin to assess the nature of kidney damage. The CBL also provides reagents, shippers, and instructions to all participating sites for submission of blood, plasma, sera, urine, hair and nail samples to NIH repositories. In conjunction with the Clinical Coordinating Centers, the CBL provides training of coordinators and investigators of each participating site, information and instruction concerning the conduct of each study visit, expertise in the biochemical methodology and clinical interpretation of these analyses. The CBL collaborates with the Data Coordinating Center (DCC) to optimize the GFR studies, better understand the progression of chronic kidney disease, provide clinical correlation with epidemiological projections, establish quality control of all assays, and generate new formulas to estimate GFR during visits when an iohexol study is not performed. The CBL regularly participates at Steering Committee meetings and conference calls as well as in the generation of abstracts, presentations, and manuscripts in order to contribute to and document the success of the CKiD study. The CBL's effort in the CKiD study is summarized in five specific aims. First, continue to provide accurate, precise, and most efficient measures of iohexol-based GFR, because it is the key independent variable against which measures of growth, cardiovascular disease, and neurocognition are examined. Second, continue to provide accurate and precise measurements of general kidney health status, utilizing biochemical assays in a licensed clinical laboratory with appropriate quality controls. Third, work closely with the DCC to provide accurate estimates of GFR and determine time-dependent changes in GFR during visits when iohexol GFR is not performed. Fourth, continue to improve and streamline the iohexol-based GFR measurement to maintain recruitment and retention of CKiD subjects. Fifth, continue to provide to the participating clinical sites laboratory kits for the collection and handling of samples, accurately receive, process, and analyze these samples on a daily basis, and provide timely data entry into the CKiD web-based data base for access by the participating clinical sites, Clinical Coordinating Centers, and Data Coordinating Center. The long term goal is to provide accurate assays to characterize the CKiD population and maintain recruitment and retention of CKiD subjects.

中央生物化学实验室（CBL）在更新中取得了关键的领导地位 前瞻性研究儿童慢性肾脏疾病（CKID）。 CBL负责提供 参与临床部位，以及执行iohexol-所需的试剂，供应，托运人和方案 基于肾小球滤过率（GFR）研究并将血液运送到罗切斯特大学 用于分析关键肾脏决定因素的实验室，包括CR，BUN，电解质，葡萄糖，CA，P，完整 PTH，维生素D，WRCRP，脂质筛查和胱抑素C。同样，尿液也被收集并运输以蛋白质， 肌酐和微量白蛋白，以评估肾脏损伤的性质。 CBL还提供试剂， 托运人和所有参与站点的指示，用于提交血浆，血浆，血清，尿液，头发和指甲 样品到NIH存储库。结合临床协调中心，CBL提供培训 每个参与网站的协调员和调查人员，有关该网站的信息和指导 每次研究访问的进行，生化方法论方面的专业知识和这些临床解释 分析。 CBL与数据协调中心（DCC）合作，以优化GFR研究， 更好地了解慢性肾脏疾病的进展，提供与流行病学的临床相关性 预测，建立所有测定法的质量控制，并在访问期间生成新的公式以估算GFR 当未进行iohexol研究时。 CBL定期参加指导委员会会议和 电话会议以及摘要，演示和手稿的产生 为CKID研究的成功做出贡献和记录。 CBL在CKID研究中的努力是 总结以五个具体目标。首先，继续提供准确，精确，最有效的措施 基于iohexol的GFR，因为它是衡量增长度量的关键独立变量 检查了心血管疾病和神经认知。其次，继续提供准确和精确的 使用持牌临床实验室中的生化测定法测量一般肾脏健康状况 具有适当的质量控制。第三，与DCC紧密合作，以提供GFR和GFR的准确估计 当未执行iohexol GFR时，确定访问期间GFR的时间依赖性变化。第四， 继续改进和简化基于iohexol的GFR测量，以维持招聘和 保留CKID受试者。第五，继续向参与的临床站点提供实验室套件 每天准确接收，处理和分析样品的处理和处理这些样品， 并及时将数据输入到基于CKID的基于网络的数据库中，以供参与的临床访问 站点，临床协调中心和数据协调中心。长期目标是提供准确的 表征CKID人群​​并保持CKID受试者的招募和保留的测定。