Novel Biomarkers in Cardiac Surgery to Detect Acute Kidney Injury

心脏手术中检测急性肾损伤的新型生物标志物

• 批准号: 7837008
• 负责人: Chirag R Parikh
• 金额: $ 31.32万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-07-15 至 2011-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7837008
• 关键词: Acetylcysteine; Acute Kidney Failure; Acute Renal Failure with Renal Papillary Necrosis; Adverse effects; Affect; Age; Algorithms; American; Area; Attenuated; Award; Basic Science; Biological Markers; Cardiac Surgery procedures; Cessation of life; Characteristics; Clinical; Clinical Data; Clinical Trials; Cohort Studies; Complication; Creatinine; Development; Diagnosis; Dialysis procedure; Dopamine; Early Diagnosis; Failure; Fenoldopam; Functional disorder; Gelatinase A; Gender; Glomerular Filtration Rate; Grant; Health Services Research; Hospitalization; Hospitals; Hour; Human; Injury; Interleukin-18; Kidney; Minor; Mus; National Institute of Diabetes and Digestive and Kidney Diseases; Nephrology; Operative Surgical Procedures; Outcome; Patients; Postoperative Period; Publications; Race; Receiver Operating Characteristics; Renal function; Research; Research Personnel; Risk; Risk Assessment; Sampling; Sensitivity and Specificity; Serum; Severities; Societies; Stratification; Testing; Time; Translational Research; Tribes; Troponin; Urine; acute coronary syndrome; clinical Diagnosis; experience; high risk; improved; investigator training; mortality; muscle form; novel; patient oriented; post gamma-globulins; pre-clinical; preclinical study; premature; prevent; programs; prospective

DESCRIPTION (provided by applicant): Acute kidney Injury (AKI), a common complication after cardiac surgery, has a high impact on clinical outcomes. The diagnosis of AKI by serum creatinine usually is delayed and occurs 2-3 days after the surgery. The failure of prior interventional studies in cardiac surgery to attenuate AKI may be attributed to the delays in the diagnosis of AKI. The TRIBE-AKI (Translational Research Investigating Biomarkers in Early Acute Kidney Injury) Clinical Consortium was established to accelerate the development of biomarkers. The consortium is a multi-disciplinary group and includes investigators from five major academic centers and who have expertise in pre-clinical, translational, epidemiologic, and health services research. In the present project, the consortium will study the following three biomarkers for early diagnosis of AKI: urine interleukin 18 (IL-18), neutrophil gelatinase associated lipocalin (NGAL), and cystatin C. The consortium will conduct a prospective multi-center observational cohort study of 1800 patients receiving cardiac surgery. Serial urine and serum samples will be collected from the participating patients, along with some clinical data during hospitalization. We will compare the timing of increases in biomarker levels with the clinical diagnosis of AKI and we will demonstrate the ability of the biomarkers for early diagnosis by 24-48 hours. Also, we will evaluate the hypothesis that compared with serum creatinine, cystatin C will improve pre-operative risk stratification, and urine IL-18 and NGAL levels will be better markers of post-operative AKI along with a potential to prognosticate its severity. The availability of new biomarkers to replace serum creatinine will allow for the early and accurate diagnosis of AKI. The ultimate findings of this study will pave the way for larger multi-center studies of these biomarkers in other clinical conditions and for interventional clinical trials to prevent or to treat AKI.

描述（由申请人提供）：心脏手术后常见并发症急性肾脏损伤（AKI）对临床结局产生了很大影响。通过血清肌酐诊断为AKI通常会延迟，并在手术后2-3天发生。心脏手术中先前的介入研究失败可能归因于AKI诊断的延迟。建立了临床财团，以加速生物标志物的发展，该部落阿基（调查生物标志物的转化研究研究）。该财团是一个多学科小组，包括来自五个主要学术中心的研究人员，他们在临床前，翻译，流行病学和卫生服务研究方面具有专业知识。在本项目中，该联盟将研究以下三种生物标志物，以早期诊断为AKI：尿中介素18（IL-18），中性粒细胞明胶相关的脂肪蛋白（NGAL）和Cystatin C.联盟C将进行1800例接受的预期多中心观察同胞研究。将从参与患者那里收集连续尿液和血清样品，以及住院期间的一些临床数据。我们将比较生物标志物水平增加的时间与AKI的临床诊断，我们将在24-48小时内证明生物标志物有能力早期诊断。此外，我们将评估以下假设：与血清肌酐相比，胱抑素C将改善术前的风险分层，尿液IL-18和NGAL水平将是术后AKI的更好标志物，并预测其严重性。新生物标志物替代血清肌酐的可用性将允许对AKI的早期和准确的诊断。这项研究的最终发现将为在其他临床条件下对这些生物标志物的多中心研究和介入的临床试验铺平道路，以预防或治疗AKI。