跳至主要内容
临床试验/NCT00572715
NCT00572715撤回不适用

Acute Kidney Injury in Neonates

University of Alabama at Birmingham1 个研究点 分布在 1 个国家开始时间: 2010年1月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Characterize the incidence and risk factors of AKI in critically ill neonates

研究概览

简要总结

Our first aim is to describe how common a sudden decrease in renal function happens in infants in a neonatal intensive care unit. We also want to see how a sudden loss of renal function affects survival. Finally, we will explore non-invasive markers to identify a sudden decrease in renal function from urinary samples.

详细描述

Advancements in the field of peri-natal medicine has improved the survival of critically ill neonates but yet many still do not survive, and many more are left with long-term damage to vital organ systems. Very little data is available on the impact that acute kidney injury (AKI) has on survival in term neonates, but adult and pediatric studies that show that even mild AKI independently impacts survival after correcting for severity of illness. The role that AKI impacts survival in neonates is likely to be greater than adults as this acute injury occurs in context of impaired and ongoing kidney development.

Our ability to improve outcomes in children and adults with AKI has been hampered by the inability to recognize AKI early in the disease process. Thus, the work on early non-invasive biomarkers of renal injury has brought great optimism to the field of AKI. Serum and urinary levels of neutrophil gelatinase-associated lipocalin (NGAL), urinary interleukin 18 (IL-18) others are markedly elevated several hours after AKI as opposed to serum creatinine which takes days to rise after the inciting event. Early non-invasive biomarkers of AKI have not been tested in neonates.

Inclusion criteria - Families of infants (birthweight >1500g) be asked to participate in the study.

Exclusion criteria - Infants with prenatal renal ultrasound diagnosis of severe hydronephrosis or other known renal abnormalities will be excluded

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
1 Minute 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Families of infants (birthweight >1500g) be asked to participate in the study.

排除标准

  • Infants with prenatal renal ultrasound diagnosis of severe hydronephrosis or other known renal abnormalities will be excluded

结局指标

主要结局

Characterize the incidence and risk factors of AKI in critically ill neonates

时间窗: 2 years

次要结局

  • Compare Hospital outcomes of critically ill neonates with and without AKI. Test the ability of known noninvasive urinary biomarkers ability to detect AKI in neonates(2 years)

研究者

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

David Askenazi

Principal Investigator

University of Alabama at Birmingham

研究点 (1)

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