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: 7588893
• 负责人: Chirag R Parikh
• 金额: $ 74.98万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-05-01 至 2012-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7588893
• 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(申请人提供)：急性肾损伤(AKI)，心脏手术后的常见并发症，对临床结果有很高的影响。AKI的诊断通常延迟于术后2-3天。心脏外科先前的介入研究未能减轻AKI，可能归因于AKI诊断的延迟。TRibe-AKI(翻译研究调查早期急性肾损伤生物标记物)临床联盟的成立是为了加速生物标记物的发展。该联盟是一个多学科小组，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拥有专业知识。在本项目中，该联盟将研究以下三种早期诊断AKI的生物标志物：尿液白细胞介素18(IL-18)、中性粒细胞明胶酶相关脂蛋白(NGAL)和胱抑素C。该联盟将对1800名心脏手术患者进行前瞻性多中心观察性队列研究。将从参与的患者身上收集连续的尿液和血清样本，以及住院期间的一些临床数据。我们将比较生物标记物水平升高的时间与AKI的临床诊断，并将在24-48小时内展示生物标记物早期诊断的能力。此外，我们还将评估这一假设，即与血肌酐相比，胱抑素C将改善术前风险分层，尿IL-18和NGAL水平将是术后AKI的更好标记物，并有可能预测其严重程度。新的生物标志物取代血肌酐的可用性将使AKI的早期和准确诊断成为可能。这项研究的最终结果将为这些生物标记物在其他临床条件下的更大规模的多中心研究以及预防或治疗AKI的介入临床试验铺平道路。