USE OF ACUTE KIDNEY INJURY BIOMARKERS TO PREDICT IMPAIRED MILRINONE PHARMACOKINETICS IN CHILDREN FOLLOWING CARDIAC SURGERY
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Biomarker elevation and milrinone clearance
研究概览
简要总结
Acute kidney injury (AKI) occurs in 40% of children following heart surgery. Serum creatinine (Scr) is a late biomarker of AKI, rising 24-48 hours after surgery. Thus, for medicines excreted in the urine, AKI could potentially lead to toxic levels in the blood. Urinary biomarkers have the ability to detect AKI earlier. Whether early detection of AKI through urinary biomarkers can predict altered drug levels is unknown.
Milrinone is used to improve heart function after surgery, but accumulates in AKI resulting in low blood pressure. Dose adjustments are not currently possible because of the late rise in SCr, and are based on clinical parameters that may lead to clinically relevant over or under-dosing. Thus, this study will address an important knowledge gap being the first to use elevations of AKI biomarker concentrations to anticipate increased milrinone levels.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Day 至 1 Year（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing cardiothoracic surgery with cardiopulmonary bypass
- •weight greater than 2500 grams (5 pounds 8 ounces) at the time of surgery
- •gestational age > 36 weeks
- •age less < to 1 year
- •infants with complex congenital heart disease
- •use of milrinone in the intra-operative and post-operative period.
排除标准
- •Pre-existing kidney disease (structural and functional abnormalities) as determined by the Principal Investigator
- •use of aminoglycosides within 48 hours of planned surgery
- •cardiac arrest prior to cardiac surgery
- •extracorporeal membrane oxygenation prior to cardiac surgery
- •urinary tract infection prior to surgery
- •repair of an isolated atrial or ventricular septal defect
结局指标
主要结局
Biomarker elevation and milrinone clearance
时间窗: By 24 hours
The primary outcome variables for Aim 1 are an elevation in urinary AKI biomarkers to predict a 25% reduction in milrinone clearance.
次要结局
- Creatinine elevation and milrinone clearance(by 72 hours)