Prognostic Markers of Inflammation in Infants Undergoing Cardiopulmonary Bypass (ProCard): an Observational Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Biomarker levels and their relationship to LCOS
研究概览
简要总结
This study evaluates the effect of heart-lung bypass on babies undergoing cardiac surgery. The investigators want to learn more about the inflammation that exposure to bypass creates in the body by studying markers of inflammation and cell injury in the bloodstream. Additionally, the investigators want to examine if these markers can predict which babies develop post-surgical complications. The hypothesis is that babies who undergo bypass will have higher levels of these markers than babies not exposed to bypass and that these markers will correlate with how the baby does clinically after surgery.
This study will evaluate markers via blood sampling in babies with congenital heart disease who do not undergo cardiac surgery, those that undergo surgery without bypass, and those that undergo surgery with bypass. The overall goal is that this study will lead to useful biomarkers and lay the groundwork for future novel therapies aimed at improving outcomes for babies who require heart-lung bypass.
详细描述
This is a minimal risk observational study looking at markers of inflammation and cell injury in the bloodstream of babies with congenital heart disease, with a particular emphasis on whether these markers can predict low cardiac output syndrome in infants who undergo heart-lung bypass. Low cardiac output syndrome is a common postoperative complication marked by poor blood flow to the body affecting nearly 1/3 of infants post-bypass and is associated with significant morbidity and mortality.
Babies not requiring surgery will serve as the control group. Infants in group 1 will have 0.5 ml of blood drawn prior to discharge. This will be scavenged from the laboratory when possible. Infants in groups 2 and 3 will require serial blood draws over peri-operative time points each in the volume of 0.5 ml.
Group 2:
T0 = Before surgery (in the OR) T1 = After chest closure or end of case (in the OR) T2 = On admission to the pediatric intensive care unit T3 = Timed 4-6 hours after the time of admission T4 = Timed 12 hours (+/- 1 hour) after the time of admission T5 = Timed 24 hours (+/-1 hour) after the time of admission
Group 3:
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants < 6 months of age
- •Born at ≥ 36 weeks gestational age
- •Birth weight ≥ 2.5 kilograms
- •Postnatally confirmed congenital heart disease by echocardiogram
排除标准
- •Requiring ≥ 2 vasopressors prior to surgery
- •Preoperative proven sepsis within one week of surgery
- •Prior surgery within one week of cardiac repair (except PA banding which is not excluded)
- •Cardiac catheterization within one week of surgery
- •Significant extra-cardiac anomalies that may impair organ function
结局指标
主要结局
Biomarker levels and their relationship to LCOS
时间窗: Baseline level and described time points over the first twenty-four hours postoperatively
Changes in markers of inflammation and cell injury (histones, IL-6, etc.) and correlation with patients who develop low cardiac output syndrome
次要结局
- Hospital length of stay(Participants will be followed throughout entire hospital course, maximum length of follow-up one year)
- Extracorporeal membrane oxygenation (ECMO)(First 48 hours postoperatively)
- Mortality risk(PIM-2 calculated within one hour of admission to PICU and PRISM-3 calculated at 12 and 24 hours after PICU admission)
- ICU length of stay(Participants will be followed throughout PICU/CVICU stay, maximum length of follow-up one year)
- Mortality(Participants will be followed throughout hospital course, maximum length of follow-up one year)
- Low cardiac output syndrome(Assessed at 48 hours postoperatively)
- Length of mechanical ventilation(Participants will be followed throughout hospital course, maximum length of follow-up one year)
- Acute kidney injury(Participants will be followed for the first twenty four hours postoperatively)
- Change in level of inflammatory response(Baseline, up to 24 hours)