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临床试验/NCT03034876
NCT03034876Unknown不适用

Acute Kidney Injury Based on Neutrophil Gelatinase-Associated Lipocalcin (NGAL) in a Pediatric Intensive Care Unit of Tertiary Care Hospital Karachi, Pakistan

Aga Khan University0 个研究点目标入组 140 人开始时间: 2017年3月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
140
主要终点
Incidence of Acute Kidney Injury

研究概览

简要总结

Acute Kidney Injury is common in critically ill children and is associated with high morbidity and mortality in pediatric intensive care unit. The serum creatinine is still a gold standard test for diagnosis of AKI, but it rises after 1 to 3 days of injury . However, Neutrophil Gelatinase-Associated Lipocalcin (NGAL) is an emerging biomarker in identifying AKI at an early stages, which may in future help us in promptly instituting reno-protective interventions like avoidance of nephrotoxic exposure and contrast agents, maintenance of euvolemia and perfusion pressure which will not only preventing kidney from further failing, decrease the use of very expensive and complicated renal supportive therapy like continuous renal replacement therapy (CRRT) as well as in decreasing morbidity and mortality related to AKI.

详细描述

Introduction:

Acute kidney injury (AKI) is complex disorder affecting the millions of children around the world where approximately 46% of critically ill individual developed acute kidney injury every year (1, 2). An annual incidence of 3.3 cases/100,000 children along with hospital mortality rate of up to 25-50% have reported from developed countries (3) This is even high for developing countries, where annual incidence is 30-50% (4, 5). Furthermore, acute kidney injury leads to significant healthcare use, with cost estimated between 8 billion dollars (4). An early diagnosis is the key to prevent morbidity and mortality related to AKI.

The diagnosis of AKI depends upon elevated serum creatinine level or decrease in urine output . Early detection of AKI is essential. The currently use creatinine clearance (CrCl) is calculated through Schwartz formula. The level of serum creatinine is poor marker for early diagnosis. Because it varies with age, gender, hydration and muscle mass and metabolism. Creatinine never rise until >50% of renal function lost, amount of tubular secretion overestimate at lower GFR, and in acute changes in GFR. During acute changes of GFR in AKI, serum creatinine doesn't accurately depict kidney function until steady state equilibrium has been achieved, which may require several days. There are some biomarker, with high sensitivity and specificity, which can be used as a tool for early detection of AKI, and prevent the burden of mortality and morbidity in intensive care unit (6, 7). Neutrophil gelatinase-associated Lipocalcin (NGAL) recently identified as one of robust marker in AKI (8). Several published reports that plasma NGA is raised in acute kidney injury before rise in serum creatinine (9). A Study conducted by Mishra et al, in US showed that the 2 hours sensitivity is 70% and specificity 94% for NGAL to predict AKI (10). A developed country data showed 84% and 79% sensitivity , and 96% and 90% specificity of NGAL to predict the AKI (2, 11) , (see Annexure 1) . However, there is scarce of information available as plasma NGAL is an early diagnostic marker from Pakistan.

Rationale:

We know that serum creatinine is a gold standard for diagnosis of AKI it is cheaper test to diagnose , but it rises after 1 to 3 days of injury . However, NGAL is a relatively costly test but an emerging biomarker in identifying AKI at an early stages, which may in future help us in promptly instituting reno-protective interventions like avoidance of nephrotoxic exposure and contrast agents, maintenance of euvolemia and perfusion pressure which will not only preventing kidney from further failing, decrease the use of very expensive and complicated renal supportive therapy like continuous renal replacement therapy (CRRT) as well as in decreasing morbidity and mortality related to AKI.

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 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • All critically ill children who is recieving inotrope in pediatric intensive care unit -

排除标准

  • Pre-existing kidney disease
  • Chronic kidney disease

结局指标

主要结局

Incidence of Acute Kidney Injury

时间窗: within 24 hour

serum will sent to plasma any time of day and test will run once a day

次要结局

未报告次要终点

研究者

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

Anwar ul Haq

Associate Professor

Aga Khan University

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