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临床试验/NCT04387149
NCT04387149Unknown不适用

Biomarkers of Acute Kidney Injury Following Cardiopulmonary Bypass Surgery-supported Cardiac Surgery

University of Saskatchewan1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2020年1月6日最近更新:
适应症

试验速览

阶段
不适用
入组人数
400
试验地点
1
主要终点
Increased MMP-2 and -9 in patients that develop CSA-AKI

研究概览

简要总结

Acute kidney injury occurs in up to 30% of patients undergoing cardiac surgery. Cardiac surgery associated-acute kidney injury (CSA-AKI) is characterized by a sudden and sustained decrease in renal function with insufficient elimination waste products. The problem is that postoperative diagnosis of CSA-AKI is delayed because it relies solely upon the slow and unreliable rise in serum creatinine (SCr) levels that may lead to delayed start in treatment and increased risk of adverse outcomes. We hypothesize that Matrix Metalloproteins (MMPs) -2, -9 and Neutrophil gelatinase-associated lipocalin (NGAL) are associated with and earlier detectors of CSA-AKI compared to levels of SCr.

详细描述

Cardiopulmonary bypass (CPB), although essential to the performance of most cardiac operations, has been shown to cause injury to other organs, particularly to the kidneys and brain. Matrix Metalloproteins (MMPs) are ubiquitous proteolytic enzymes that degrade extracellular matrix and have been shown to be involved in injury to transplant kidneys. To date, no interventions are available to decrease the risk of cardiac surgery associated-acute kidney injury (CSA-AKI).

NGAL is a known indicator of injury to kidney, thus making it a promising biomarker for CSA-AKI. It may be that a single biomarker will not be sensitive and specific across the spectrum of CSA-AKI. This research investigates MMP-2, -9 and Neutrophil gelatinase-associated lipocalin (NGAL) and their association with and earlier detection of CSA-AKI compared to levels of SCr.

We hypothesize that increased activity of MMPs are associated with CSA-AKI. Furthermore, MMP-2 and/ or -9 may be predictors and/ or biomarkers for the early detection of CSA-AKI compared to serum levels of creatinine.

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 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The inclusion criteria consisted of both sexes, 18-85 years of age, undergoing elective or urgent cardiac surgery with a hemoglobin (Hgb) >100 g/L.

排除标准

  • The exclusion criteria included were patients for emergent surgery, pre-existing chronic kidney disease (eGFR<30 mL/min) on dialysis or prescribed nephrotoxic mediations.

结局指标

主要结局

Increased MMP-2 and -9 in patients that develop CSA-AKI

时间窗: Pre-CPB, 10 min post-CPB time point, 4 hours post-CPD

Increased MMP-2 and -9 activity in serum and or urine in patients that develop CSA-AKI

次要结局

  • Increased NGAL levels in patients that develop CSA-AKI(Pre-CPB, 10 min post-CPB time point, 4 hours post-CPD)

研究者

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

Erick McNair

Research Scientist

University of Saskatchewan

研究点 (1)

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