A Randomized Placebo Controlled Trial of Aminophylline to Prevent Acute Kidney Injury in Children After Cardiac Surgery With Cardiopulmonary Bypass
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Acute Kidney Injury Measured by Kidney Diseases: Improving Global Outcomes (KDIGO) AKI Serum Creatinine Criteria
研究概览
简要总结
Children with congenital heart defects often need cardiac surgery with cardiopulmonary bypass (the "heart-lung machine"). Approximately 35 to 50% of these children will have "acute kidney injury," or damage to the kidneys, after the procedure. We currently have few medications to prevent this kidney injury. The hypothesis of this study is that giving aminophylline after heart surgery can decrease the acute kidney injury.
详细描述
Patients are randomized to receive aminophylline or placebo for 72 hours, in a blinded fashion. Serum theophylline levels monitor for safety of aminophylline dose. Goal theophylline levels is 5-7 mcg/ml. Laboratory results will be faxed directly to the pharmacy who will adjust subsequent aminophylline dosing to maintain appropriate theophylline levels. Urine output and serum creatinine levels will be monitored to assess acute kidney injury. Serum Neutrophil Gelatinase Associated Lipocalin (NGAL) levels will also be monitored.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Day 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Less than 18 years old, undergoing cardiac surgery with bypass
- •neonates must be at least 36 weeks gestational age
排除标准
- •History of arrythmia or seizure, on extracorporeal membrane oxygenation (ECMO) support, already taking aminophylline/theophylline, liver failure, sepsis, on renal replacement therapy
研究组 & 干预措施
Aminophylline
Patients to receive aminophylline 5 mg/kg IV bolus then 1.8 mg/kg IV Q6 hours
干预措施: Aminophylline (Drug)
Placebo
Normal Saline Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Acute Kidney Injury Measured by Kidney Diseases: Improving Global Outcomes (KDIGO) AKI Serum Creatinine Criteria
时间窗: 5 days
Acute Kidney Injury measured by Kidney Diseases: Improving Global Outcomes (KDIGO) AKI Serum Creatinine criteria; KDIGO Stage is a measure of acute kidney injury.
次要结局
未报告次要终点
研究者
David Axelrod
MD, Clinical Assistant Professor
Stanford University