Central Biochemistry Laboratory of the CKiD Consortium

CKiD 联盟中央生物化学实验室

• 批准号: 8142206
• 负责人: GEORGE J SCHWARTZ
• 金额: $ 30.5万
• 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/8142206
• 关键词: 25-hydroxyvitamin D; 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）在续签儿童慢性肾脏疾病（CKID）的前瞻性研究中取得了关键的领导地位。 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.同样，将尿液用于蛋白质，肌酐和微量白蛋白，以评估肾脏损伤的性质。 CBL还向所有参与的地点提供了试剂，托运人和指令，以提交血浆，血浆，血清，尿液，头发和指甲样品向NIH存储库。结合临床协调中心，CBL提供了每个参与站点的协调员和研究人员的培训，有关每次研究访问的进行的信息和指导，生化方法论方面的专业知识以及这些分析的临床解释。 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，与流行病学预测提供临床相关性，对所有测定法建立质量控制，并在不进行iohexol研究期间访问期间为GFR产生新的公式。 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，以便为CKID研究的成功做出贡献和记录。 CBL在CKID研究中的努力总结了五个特定目标。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，继续在具有适当质量控制的有执照的临床实验室中利用生化测定法，以提供一般肾脏健康状况的准确和精确的测量。第三，与DCC紧密合作，以提供GFR的准确估计，并确定未执行iohexol GFR时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CKID受试者的招聘和保留。第五，继续向参与的临床站点提供实验室套件，以收集和处理样品，每天准确接收，处理和分析这些样品，并及时将数据输入基于CKID Web的数据库，以通过参与的临床站点，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测定法，以表征CKID人群​​并保持CKID受试者的招聘和保留。