Central Biochemistry Laboratory of the CKiD Consortium

CKiD 联盟中央生物化学实验室

• 批准号: 7681316
• 负责人: GEORGE J SCHWARTZ
• 金额: $ 33万
• 依托单位: UNIVERSITY OF ROCHESTER
• 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 2013-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7681316
• 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

DESCRIPTION (provided by applicant): 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, CRP, 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.

描述（由申请人提供）： 中央生物化学实验室（CBL）在儿童慢性肾脏病（CKiD）前瞻性研究的更新中占据了关键的领导地位。CBL负责为参与的临床研究中心提供进行基于碘海醇的肾小球滤过率（GFR）研究所需的试剂、供应品、运输箱和方案，并将血液运送至罗切斯特大学实验室，以分析关键肾脏决定因素，包括Cr、BUN、电解质、葡萄糖、Ca、P、完整PTH、维生素D、CRP、脂质筛查和胱抑素C。同样，收集尿液并转运蛋白质、肌酐和微量白蛋白，以评估肾损伤的性质。CBL还向所有参与研究中心提供试剂、运输箱和说明，以便将血液、血浆、血清、尿液、毛发和指甲样本提交至NIH储存库。CBL与临床协调中心合作，为每个参与研究中心的协调员和研究者提供培训，提供有关每次研究访视的信息和说明，提供生化方法学方面的专业知识和这些分析的临床解释。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，提供与流行病学预测的临床相关性，建立所有测定的质量控制，并生成新的公式来估计未进行碘海醇研究时访视期间的GFR。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，以促进并记录CKiD研究的成功。CBL在CKiD研究中的努力总结为五个具体目标。首先，继续提供准确、精确和最有效的措施， 基于碘海醇的GFR，因为它是衡量生长的关键自变量， 心血管疾病和神经认知进行检查。其次，继续提供准确和精确的测量一般肾脏健康状况，利用生化分析在一个有执照的临床实验室与适当的质量控制。第三，与DCC密切合作，提供GFR的准确估计值，并确定在未进行碘海醇GFR检查的访视期间GFR的时间依赖性变化。第四，继续改进和简化基于碘海醇的GFR测量，以维持CKiD受试者的招募和保留。第五，继续向参与的临床研究中心提供用于采集和处理样本的实验室试剂盒，每天准确接收、处理和分析这些样本，并及时将数据输入CKiD网络数据库，供参与的临床研究中心、临床协调中心和数据协调中心访问。长期目标是提供准确的检测方法来表征CKiD人群，并维持CKiD受试者的招募和保留。