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临床试验/NCT03854825
NCT03854825已完成不适用

Neutral Endopeptidase for Early Detection of Acute Kidney Injury After Cardiac Surgery

Medical University of Vienna1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年10月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
NEP-levels

研究概览

简要总结

The investigators want to investigate if the urinary biomarker neprilysin can identify cardiac surgical patients suffering from postoperative AKI within 24 hours.

详细描述

Acute kidney injury (AKI) is a common complication following cardiac surgery and significantly increases morbidity, duration of hospital stay, and mortality. The diagnosis of AKI relies on changes in serum creatinine (SCr) from a baseline value or decreases in urine output. Nevertheless changes of SCr to diagnose AKI are only reliable after a minimum of 48 hours.

Neutral endopeptidase, also called neprilysin (NEP) represents a single-pass membrane glycoprotein with zinc-dependent endopeptidase activity and a short cytosolic tail and is found in epithelia, fibroblasts, and neutrophils and in soluble form in the circulation, urine, and cerebrospinal fluid. Beside the focus of interest in cardiovascular medicine for its role in heart failure, where the inhibition of NEP by the administration of sacubitril/valsartan may achieve an improvement in patients with chronic heart failure and reduced ejection fraction, there is also thought to be a link to renal damage.

NEP is expressed in the brush border of proximal tubular cells, which is first shed in renal damage and therefore it is a marker for tubular damage when it is measurable in urine In this study the investigators want to investigate if NEP is a marker for earlier detection of AKI after elective cardiac surgery compared to the currently recommended Kidney Disease - Improved Global Outcomes (KDIGO) guidelines for acute kidney injury. Also, the investigators want to investigate at predefined time points the occurrence and the progression of tubular damage during cardio-pulmonary bypass (CPB) in a closed-meshed NEP detection.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing an elective cardiac surgical intervention

排除标准

  • Emergency procedures
  • Heart transplantation
  • Elective left ventricular assist device (LVAD) implantation
  • Pulmonary thrombendarterectomy
  • Declined informed consent
  • Age < 18 years
  • Pregnant woman
  • Preoperative renal replacement therapy (RRT)
  • Receiving medication containing sacubitril

结局指标

主要结局

NEP-levels

时间窗: 24 hours

Difference of NEP-levels after cardiac surgery on the first postoperative day

次要结局

  • Increase of NEP(approximately 6 hours)
  • NEP-levels(approximately 6 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Martin Bernardi

Neutral Endopeptidase for early detection of acute kidney injury after cardiac surgery

Medical University of Vienna

研究点 (1)

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