Efficacy of Nitric Oxide Administration in Attenuating Ischemia/Reperfusion Injury During Neonatal Cardiopulmonary Bypass.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Change in Biochemical Markers of Ischemia/Reperfusion Injury and Oxidative Damage (Positive ~ Increase From Pre-op)
研究概览
简要总结
Around 7500 neonates born yearly in the United States have complex congenital heart disease that require surgical repair in the first few days of life. The complexity of the surgical repair requires long periods of cardiopulmonary bypass (CPB) and the use of intermittent periods of low flow or complete circulatory arrest. The immature neonatal vital organs are more prone to the complications of the cardiopulmonary bypass circulation, namely ischemia/reperfusion (I/R) injury and systemic inflammatory response. Inhaled nitric oxide (NO) is used frequently in neonates for the treatment of pulmonary hypertension, Additionally, many studies have shown that NO has an anti-inflammatory effect by reducing I/R injury and endothelial dysfunction.
The purpose of this pilot study is to assess the efficacy of NO administration via the CPB circuit in attenuating the CPB induced I/R injury and systemic inflammatory reaction in neonates undergoing repair of complex congenital heart defects. Specific goals will be to demonstrate that NO use via CPB will:
- Decrease markers of I/R injury and systemic inflammatory response.
- Decrease platelet activation leading to reduced postoperative bleeding and transfusion requirements.
- Decrease postoperative organ dysfunction, and hence decrease operative mortality and postoperative morbidity.
Twelve neonates undergoing repair of complex congenital heart defects will receive NO via the CPB circuit, for the duration of surgery. They will be compared to a control group of 12 similar patients. Serum levels of different ischemic reperfusion injury and inflammatory markers will be measured at different time points after surgery and will be correlated with different end organ function tests and clinical course in the postoperative period. The results will be compared between the two groups to try to determine the clinical benefit of NO administration through CPB circuit.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 1 Day 至 30 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neonates, age 0-30 days
- •Full term, > 37 weeks gestation
- •Birth weight ≥ 2.6 kg
排除标准
- •Preoperative sepsis
- •Preoperative renal dysfunction
- •Preoperative intracranial hemorrhage
- •Chromosomal abnormalities and/or genetic syndromes
- •Prior intervention (catheter based or surgical)
研究组 & 干预措施
Nitric oxide on CPB
neonates receiving inhaled NO into the cardiopulmonary bypass circuit during cardiac surgery
干预措施: Inhaled Nitric Oxide (Drug)
control
neonates not receiving inhaled NO into the cardiopulmonary bypass
干预措施: placebo (Drug)
结局指标
主要结局
Change in Biochemical Markers of Ischemia/Reperfusion Injury and Oxidative Damage (Positive ~ Increase From Pre-op)
时间窗: Pre-op baseline and up to 12 hours after surgery
The primary study endpoints are to evaluate whether NO delivered through the neonatal cardiopulmonary bypass (CPB) circuit can decrease various biochemical markers of ischemia/reperfusion injury and oxidative damage. Markers to be analyzed will include cardiac troponin I, interleukins (IL), tumor necrosis factor, N-terminal prohormone for brain natriuretic peptide (NT-proBNP),lactate dehydrogenase (LDH), plasma anti-oxidant levels, plasma malondialdehyde (MDA) levels.
次要结局
- Total Fluid Balance at 48 Hours(48 hours post surgery)
- Time Until Start of Diuretic Therapy(Pre-op to 72 hours post surgery)
- Inotropic Score Day 1(24 hours post surgery)
- Length of Intubation and PSHU Stay(Surgery to discharge)