Assessment of Urinary Neutrophil Gelatinase-Associated Lipocalin (NGAL) Ito Predict Acute Kidney Injury (AKI) in the NICU in Infants Receiving Multiple Nephrotoxic Medications (NICU NINJA NGAL)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 148
- 试验地点
- 2
- 主要终点
- Percentage of patients with elevated urine NGAL
研究概览
简要总结
Nephrotoxic medication (NTMx) exposure is one of the most commonly cited causes of acute kidney injury (AKI) in hospitalized children, and is the primary cause of AKI in 16% of cases. Through initial work at UAB/Children's of Alabama Hospital, NTMx exposure was found to be potentially modifiable and the associated AKI is an avoidable adverse safety event. Currently, only serum Creatinine monitoring is available to monitor for NTMx-associated AKI. The hypothesis of this NINJA NGAL study is that urine NGAL is highly sensitive to detect NTMx-associated AKI. UAB/Children's of Alabama is bringing urine NGAL measurement to the infants in the NICU to detect NTMX-associated AKI.
详细描述
Nephrotoxic medication-induced acute kidney injury (NTM-AKI) is a relevant yet underdiagnosed morbidity in the neonatal intensive care unit (NICU).
Up to 87% of very low birth weight infants are exposed to at least one nephrotoxic medication (NTM). NTM-AKI is associated with poor short and long-term outcomes.
Presently, no treatments exist for AKI beyond supportive care.
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
- — 至 1 Year（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all NICU inpatients under 1 year of age; greater than 4 days of age that are
- •Receiving 3 or more nephrotoxic medications on the same day OR
- •Receiving 3 or more days of an intravenous aminoglycoside or vancomycin
排除标准
- •Less than 4 days of age
- •Currently being treated for a urinary tract infection
- •Presence of an acute kidney injury prior to enrollment
结局指标
主要结局
Percentage of patients with elevated urine NGAL
时间窗: Daily for one week after meeting criteria for nephrotoxic medication exposure
NGAL is an early, sensitive, non-invasive urine biomarker for AKI.
次要结局
未报告次要终点
研究者
David Askenazi
Principal Investigator
University of Alabama at Birmingham