Efficacy of Nitric Oxide Administration During Cardiopulmonary Bypass in Neonates at Reducing the Risk of Acute Kidney Injury: a Preliminary Double-blind Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Glomerular Filtration Rate
研究概览
简要总结
Acute kidney injury following cardiac surgery for congenital heart defects in children is a major cause of both short- and long-term morbidity and mortality, affecting up to 60% of high risk patients. Despite effort, to date, no successful therapeutic agent has gained widespread success in preventing this postoperative decline in renal function. Based on preliminary data available in the literature, we hypothesize that nitric oxide (gNO), administered during cardiopulmonary bypass (CPB), may reduce the risk of acute kidney injury (AKI) via mechanisms of reduced inflammation and vasodilation. In this pilot study, 40 neonates undergoing cardiac surgery will be randomized to receive intraoperative administration of 20 ppm of nitric oxide to the oxygenator of the cardiopulmonary bypass circuit or standard CPB with no additional gas.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 31 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neonates (≤31 days) undergoing cardiac surgery with cardiopulmonary bypass for congenital heart disease
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 <2.2 kg,
- •Gestational age <36 weeks,
- •Major extracardiac congenital anomalies.
研究组 & 干预措施
gNO Group
Participants in the treatment group will receive gNO added to the oxygenator gas flow at 20 ppm throughout the duration of cardiopulmonary bypass.
干预措施: gases Nitric Oxide (gNO) (Drug)
结局指标
主要结局
Glomerular Filtration Rate
时间窗: up to 72 hours postoperative
Postoperative glomerular filtration rate (GFR) measured using serum cystatin C.
Acute Kidney Injury
时间窗: up to 72 hours postoperative
Occurrence of acute kidney defined by the Kidney Disease Improving Global Outcomes (KDIGO) diagnostic classification (employing both serum creatinine and urine output criteria).
次要结局
- Length of cardiac intensive care unit (CICU) stay(up to 2 weeksfrom admission to CICU to discharge from CICU)
- Length of hospital stay(up to 30 days from hospital admission to discharge)
- Low cardiac output syndrome (LCOS)(up to 48 hours postoperative)
- Structural Kidney Injury(up to 72 hours postoperative)
- Duration of mechanical ventilation(up to 2 weeks from admission to CICU to extubation)
- Use of postoperative inhaled Nitric Oxide (iNO)(up to two weeks from CICU admission to discharge)
- ECMO free days(up to 2 weeks after surgery to CICU discharge)
- Time to negative fluid balance(up to 2 weeks from CICU admission to outcome reached)
- Urine Output(up to two weeks from CICU admission to discharge)
- Cardiac arrest(up to two weeks from CICU admission to discharge)
- Inotrope free days(up to 30 days after surgery to CICU discharge)
- Use of peritoneal dialysis(up to two weeks from CICU admission to discharge)
- Closed sternum days(up to 2 weeks from postoperative CICU admission to discharge)