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临床试验/NCT03144011
NCT03144011已完成不适用

Early Diagnosis of Acute Kidney Injury in Children With Congenital Heart Disease After Cardiopulmonary Bypass

Meshalkin Research Institute of Pathology of Circulation1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2017年2月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
150
试验地点
1
主要终点
acute renal injury on the scale pRIFLE

研究概览

简要总结

Acute kidney injury (AKI) is a common complication in patients with congenital heart defects after cardiopulmonary bypass. The death rate from AKI in critically ill children remains high and reaches 60%.

The basic criteria for diagnosing and assessing the severity of kidney injury until recently were the level of serum creatinine and the amount of urine released. However, it should be noted that the level of serum creatinine, traditionally used to assess renal function, does not significantly increase until a decrease of more than 50% of the glomerular filtration rate, in addition, its level depends also on some extrarenal causes. Artificial blood circulation and hemodilution leads to the preservation of the level of creatinine at sufficiently low levels up to 1-3 days postoperative period. The level of diuresis as well as the level of creatinine is a nonspecific criterion after cardiac surgery and depends on several factors.

Currently, in the field of acute renal injury studies, progress has been made in the emergence of new biomarkers such as the tissue inhibitor metalloproteinase-2 (TIMP-2) and insulin-like growth factor binding globulin-7 (IGFBP7), which are early markers of acute renal damage. In a study in adult patients, it was shown that the levels of TIMP-2 and IGFBP7 increased In the first 24-48 before the diagnosis of IR-associated renal damage.

Among pediatric patients with congenital heart defects, such studies are single and only present for the age group 3 and older, which also demonstrated the high specificity and prognostic significance of these biomarkers in the early diagnosis of acute renal damage.

It should also be noted that, in spite of the high specificity of the markers described, it is also necessary to note their considerable cost.

Thus, taking into account the above, it is planned to compare and identify the relationship of these indicators with such parameter as the index of renal vascular resistance, the increase of which in the pre- and postoperative period may serve as a sign of the beginning acute renal injury.

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
1 Month 至 1 Year(Child)
性别
All
接受健康志愿者

入选标准

  • Age from 1 month to 1 year Presence of congenital heart disease Radical correction of the defect in conditions of cardiopulmonary bypass

排除标准

  • Inconsistency with age criteria Cardiotonic support before surgery Acute renal, acute liver failure before surgery

结局指标

主要结局

acute renal injury on the scale pRIFLE

时间窗: 48 hours

diagnosis of acute kidney injury after cardiac surgery

次要结局

  • renal resistant index with doppler ultrasound(before, 6 hour, 24 hour)
  • TIMP-2(6 hours)

研究者

发起方
Meshalkin Research Institute of Pathology of Circulation
申办方类型
Network
责任方
Sponsor

研究点 (1)

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