RRI Compared With NephroCheckTM to Predict Acute Renal Failure After Cardiac Surgery.
Renal Resistive Index Compared With NephroCheckTM to Predict Postoperative Acute Renal Failure in Patients Undergoing Cardiac Surgery.
Postoperative acute renal failure is a frequent complication after cardiac surgery. The current practice cannot predict Acute Kidney Injuries (AKI) early enough to reduce a significant kidney assault and prevent an organic dysfunction leading to cortical tubular necrosis.
Several recent studies in cardiac surgery have shown that, both sonographic criteria, such as the Renal Resistive Index (IRR) and urinary biomarkers can predict AKI promptly. These urinary biomarkers are the 'tissue inhibitor of metalloproteinases' (TIMP-2) and the 'insulin-like growth factor binding protein' (IGFBP7). These two proteins are sought noninvasively, directly in the urine, within the same test called 'NephroCheckTM'. These markers, ultrasonographic and biologic, have the advantage of being easy to perform, accessible and seem to have both high sensitivity and specificity to predict AKI promptly after cardiac surgery. Thus, the IRR and the NephroCheckTM test could become essential tests to guide clinicians in determining rapidly whether a patient will develop AKI. However, so far, no study has compared these markers yet.
Therefore, the aim of this prospective observational study will be to compare the effectiveness of the IRR with the NephroCheckTM to predict AKI promptly after cardiac surgery. The secondary outcome will be to determine the threshold of these markers from which patients will be likely to develop AKI
研究概览
研究类型
注册 (实际的)
联系人和位置
学习地点
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Bordeaux
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Pessac、Bordeaux、法国、33604
- CHU de Bordeaux
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Elective patients
- Patients scheduled to receive an extracorporeal circulation
- Patients aged 60 and older
Patients at risk of postoperative acute kidney injury presenting at least two of the following risk factors:
- Age > 60 years.
- Arteritis defined as severe lower limb arteriopathy or carotid stenosis > 50%
- Diabetes
- Valvular or combined surgery
- Preoperative intra-aortic balloon pump.
Exclusion Criteria:
- Unable to provide informed consent
- Comatose patients
- Patients with dementia
- Patient who underwent a previous sternotomy
- Chronic renal failure (sCr clearance < 30 ml.min-1)
- Renal artery stenosis
- Endocarditis
- Emergent surgery
- Nephrotoxic treatment
- Non-sinus cardiac rhythm
学习计划
研究是如何设计的?
设计细节
- 观测模型:队列
- 时间观点:预期
队列和干预
团体/队列 |
干预/治疗 |
---|---|
Renal Resistive Index/Nephrocheck test
Patients undergoing elective cardiac surgery with extracorporeal circulation and who are at risk to develop postoperative Acute Kidney Injury.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Renal Resistive Index compared with NephroCheckTM
大体时间:Day 0 (inclusion) / after cardiac surgery
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Compare the effectiveness of the IRR with the NephroCheckTM to predict AKI after cardiac surgery.
AKI will be defined according to the RIFLE criteria.
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Day 0 (inclusion) / after cardiac surgery
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合作者和调查者
调查人员
- 首席研究员:Cédrick ZAOUTER, MD、University Hospital, Bordeaux
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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