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)在更新生物化学实验室方面发挥了关键的领导作用 儿童慢性肾脏病的前瞻性研究CBL负责提供 参与临床现场，提供实施碘海醇所需的试剂、供应品、发货人和方案- 基于肾小球滤过率(GFR)的研究和向罗切斯特大学输送血液 分析关键肾脏决定因素的实验室，包括铬、尿素氮、电解质、葡萄糖、钙、磷，完整 甲状旁腺素、维生素D、rCRP、脂质筛查和胱抑素C。类似地，尿液被收集和运输以获取蛋白质， 肌酐、微量白蛋白来评估肾脏损害的性质。CBL还提供试剂， 托运人，以及向所有参与地点提交血液、血浆、血清、尿液、头发和指甲的说明 样本送到美国国立卫生研究院的储存库。与临床协调中心合作，CBL提供培训 每一参与地点的协调员和调查人员、关于 每次研究访问的进行、生化方法学方面的专业知识以及这些的临床解释 分析。CBL与数据协调中心(DCC)合作，优化GFR研究， 更好地了解慢性肾脏疾病的进展，提供临床与流行病学的相关性 预测，建立所有化验的质量控制，并在访问期间生成新的公式来估计GFR 当没有进行碘海醇研究时。CBL定期参加指导委员会会议和 电话会议以及摘要、演示文稿和手稿的生成，以便 对CKiD研究的成功作出贡献并记录下来。CBL在CKiD研究中的努力是 总结为五个具体目标。第一，继续提供准确、准确和最有效的措施 基于碘海醇的GFR，因为它是衡量增长的关键自变量， 心血管疾病和神经认知进行了检查。二、持续提供精准精准 在有执照的临床实验室中使用生化分析测量一般肾脏健康状况 有适当的质量控制。第三，与DCC密切合作，提供准确的GFR和 确定不进行碘海醇肾小球滤过率检查期间肾小球滤过率随时间的变化。第四, 继续改进和简化以碘海醇为基础的GFR测量，以维持招募和 CKiD受试者的保留。第五，继续向参与的临床地点提供化验试剂盒，以 样品的采集和处理，每天准确地接收、处理和分析这些样品， 并及时将数据输入CKiD基于Web的数据库，以供参与的临床人员访问 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 分析CKiD人群的特征，并维持CKiD受试者的招募和保留。