Efficacy of Nitric Oxide Administration During Cardiopulmonary Bypass in Neonates at Reducing the Risk of Acute Kidney Injury
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- AKI
研究概览
简要总结
Acute kidney injury (AKI) following cardiac surgery for congenital heart defects (CHD) in children affects up to 60% of high risk-patients and is a major cause of both short- and long-term morbidity and mortality. Despite effort, to date, no successful therapeutic agent has gained widespread success in preventing this postoperative decline in renal function. Nitric oxide is an intricate regulator of acute inflammation and coagulation and is a potent vasodilator. The investigators hypothesize that nitric oxide, administered during cardiopulmonary bypass (CPB), may reduce the incidence of AKI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 1 Day 至 31 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All neonates (≤31 days) undergoing cardiac surgery with CPB for CHD will be deemed eligible for enrollment.
排除标准
- •Failure to obtain informed consent from parent/guardian
- •Clinical signs of preoperative persistent elevated pulmonary vascular resistance,
- •Emergency surgery,
- •Episode of cardiac arrest within 1 week before surgery,
- •Recent treatment with steroids and/or a condition that may require treatment with steroids (excluding steroid administration specifically for CPB),
- •Use of inhaled NO (iNO) immediately prior to surgery,
- •Structural renal abnormalities by ultrasound,
- •Preoperative AKI,
- •Use of other investigational drugs,
- •Weight less than <2 kg,
- •Gestational age <36 weeks,
- •Major extracardiac congenital anomalies,
- •Non-English speakers.
研究组 & 干预措施
Oxygen
Standard CPB without NO administered at any point intraoperatively
干预措施: Oxygen (Drug)
Nitric Oxide
Intraoperative NO entrained at 20 ppm into the oxygenator of the CPB circuit with standard care
干预措施: Nitric Oxide (Drug)
结局指标
主要结局
AKI
时间窗: 72 hours
Incidence of AKI in the first 72 hours postoperative as defined by the Kidney Disease Improving Global Outcomes (KDIGO) diagnostic classification
次要结局
- Biomarker evidence of AKI - KIM-1(72 hours)
- Biomarker evidence of AKI - IL-18(72 hours)
- Biomarker evidence of AKI - L-FABP(72 hours)
- Biomarker evidence of AKI - NGAL(72 hours)
- Biomarker evidence of AKI - urinary nitrite(72 hours)
- Impact on GFR(72 hours)
- Low Cardiac Output(48 hours)