NCT02276170终止不适用
Pharmacology of Aminophylline for Acute Kidney Injury in Neonates
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Drug concentrations of theophylline
研究概览
简要总结
Acute kidney injury (AKI) in critically ill neonates is common and associated with significant morbidity and mortality. No targeted therapeutic treatment strategies have been established for AKI in neonates. Within a clinical pharmacokinetic and pharmacodynamic conceptual framework, this project will examine the medication aminophylline as a potential treatment approach for 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
- — 至 3 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neonate < 3 months post natal age
- •Diagnosed with acute kidney injury (AKI)
- •Receiving aminophylline for AKI treatment as per local standard of care.
排除标准
- •Presence of anatomical renal anomaly based on postnatal evaluation of the patient (hydronephrosis, multicystic kidney, renal agenesis, renal dysplasia, polycystic kidney, or obstructive uropathy)
- •Patient on renal replacement therapy
- •Major genetic abnormalities (trisomy 13, 18 or 21).
结局指标
主要结局
Drug concentrations of theophylline
时间窗: Day 1 or 2 and Day 3,4, or 5
次要结局
- Change in serum creatinine level(Day 1,2,3,4,5)
- Number of participants with adverse events(5 days)
- Change in urine biomarker levels(Day 1,2,3,4,5)
- Change in renal Near-infrared spectroscopy (NIRS)(Day 1,2,3,4)
- Change in urine output(Day 1,2,3,4)
研究者
Adam R Frymoyer
Clinical Assistant Professor
Stanford University
研究点 (1)
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