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临床试验/NCT03617055
NCT03617055Unknown不适用

Early Predictor of Acute Kidney Injury in Newborns With Perinatal Asphyxia

Assiut University0 个研究点目标入组 50 人开始时间: 2019年1月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
主要终点
serum cystatin C (sCysC) as an early predictor of acute kidney injury (AKI) in neonates with perinatal asphyxia.

研究概览

简要总结

The aim of the study is to investigate the role of serum cystatin C (sCysC) as an early predictor for both diagnosis and short term outcome evaluation of acute kidney injury (AKI) in neonates with perinatal asphyxia admitted to Neonatal Intensive Care Unit (NICU) of Assiut University Children Hospital

详细描述

Acute Kidney Injury is defined as the inability of the kidneys to excrete nitrogenous waste products and maintain fluid and electrolyte homeostasis. It is fairly common in newborn population and is a major contributor factor of neonatal mortality and morbidity.

The most common form of Acute Kidney Injury in neonates is prerenal failure due to renal hypo-perfusion or ischemia. Pre-renal failure may result in intrinsic kidney failure if it is not treated promptly. The kidneys of neonates are particularly susceptible to hypo-perfusion because of the physiologic characteristics of neonatal kidneys, including high renal vascular resistance, high plasma renin activity, low glomerular filtration, decreased intra-cortical perfusion rate and decreased reabsorption of sodium in the proximal tubules in the first days of a neonatal life. Thus, newborn infants are vulnerable to acute tubular necrosis or cortical necrosis.

The cause of Acute Kidney Injury in neonates is of multi-factorial etiology and, usually, there is one or more associated contributing factor. In most studies, perinatal asphyxia and sepsis are the most commonly associated conditions.

Perinatal asphyxia is defined as abnormal neurological incident resulting in neonatal hypoxic ischemic encephalopathy , which occurs usually due to brain hypoxia and ischemic incidents. Perinatal asphyxia can result in multi-organ dysfunction through redirection of cardiac output to maintain cerebral, cardiac, and adrenal perfusion while potentially compromising perfusion to non-vital organs including kidneys, this causing Acute Kidney Injury.

The incidence of Acute Kidney Injury after Perinatal asphyxia in term neonates was shown to be around 30% to 56%. Early detection of Acute Kidney Injury could optimize and improve patient outcomes. therefore, the use of biomarkers to predict renal damage has been of interest. Serum creatinine is the most commonly used clinical measure of renal function; however, it is a poor diagnostic marker and its utility is further questionable in neonates since kidneys undergo maturational changes in postnatal period.

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 Hour 至 28 Days(Child)
性别
All
接受健康志愿者

入选标准

  • all full term neonates who are admitted to neonatal intensive care unit of Assiut University Children Hospital through the period from Jan. 2019 to Jan. 2020 with documented perinatal asphyxia

排除标准

  • preterm neonates < 37 weeks, neonates who died within the first 24 hours of admission, neonates with any congenital anomalies like skeletal, renal or urinary tract, neonates with AKI for any cause other than asphyxia and neonates with maternal history of renal failure .

结局指标

主要结局

serum cystatin C (sCysC) as an early predictor of acute kidney injury (AKI) in neonates with perinatal asphyxia.

时间窗: one year

measuring serum cystatin c in neonates with perinatal asphyxia

次要结局

  • is to determine the incidence of Acute kidney injury in neonates with perinatal asphyxia.(one year)

研究者

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

M. A. Sabra

Mohammed Abdel tawab sabra

Assiut University

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