Optimizing Pulsatility During Cardiopulmonary Bypass to Reduce Acute Kidney Injury: Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Endothelial function
研究概览
简要总结
Cardiopulmonary bypass during cardiac surgery provides blood flow to the body during surgery but has adverse effects on different organs. Blood flow during cardiopulmonary bypass may be pulsatile or non-pulsatile, which may impact normal organ function after surgery. The study will collect data on the type of cardiopulmonary bypass used during surgery and organ function to determine if there is an association between the type of bypass and organ function.
详细描述
Cardiac surgery is a high-risk elective surgical procedure frequently requiring CPB in which a machine pumps blood while the surgeon operates on the heart. CPB contributes to surgical risk by causing endothelial dysfunction and acute kidney injury (AKI). Endothelial dysfunction and AKI happen because heart lung machines typically generate non-pulsatile blood flow, which is abnormal and results in impaired tissue oxygen delivery. Normal blood flow is pulsatile due intermittent contraction and relaxation of the heart during the cardiac cycle, which produces a mechanical signal that induces endothelial cells to produce nitric oxide. Without nitric oxide, blood flow does not penetrate as deeply into organs such as the kidneys which leads to acute kidney injury. AKI increases mortality 10-fold after cardiac surgery placing many people at risk since over 400,000 people have surgery with CPB each year in the United States. Thus, pulsatile CPB may influence endothelial function and renal blood flow after cardiac surgery. This study will observe patients undergoing cardiac surgery with CPB and compare patients who receive pulsatile or non-pulsatile CPB.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 50 to 70
- •Able to provide informed consent
- •Scheduled for elective cardiac surgery with cardiopulmonary bypass
排除标准
- •Patients undergoing emergency procedures
- •Diagnosed with sepsis
- •Experiencing delirium
- •Experiencing hemodynamic instability (heart rate > 100 and systolic blood pressure < 90)
- •Patients with a mechanical circulatory support device
- •Requiring vasoactive medications before surgery
- •Patients with a reduced left ventricular ejection fraction (less than 50%)
- •Patients with a contraindication to transesophageal echocardiography
结局指标
主要结局
Endothelial function
时间窗: From intensive care unit admission after surgery to hospital discharge, up to 30 days
Percent change in flow mediated dilation of the brachial artery after cardiac surgery
次要结局
- Re-exploration for bleeding(From intensive care unit admission after surgery to hospital discharge, up to 30 days)
- Post-operative blood loss(From intensive care unit admission to 24 hours after intensive care unit admission, up to 24 hours)
- Acute kidney injury(From intensive care unit admission after surgery to intensive care unit discharge, up to 7 days)
- Perioperative death(From intensive care unit admission after surgery to hospital discharge, up to 30 days)
- Myocardial infarction(From intensive care unit admission after surgery to hospital discharge, up to 30 days)
- Renal blood flow velocity(Intra-operative time point: after cardiopulmonary bypass, up to 12 hours)
- New renal failure requiring renal replacement therapy(From intensive care unit admission after surgery to hospital discharge, up to 30 days)
- Post-operative sepsis(From intensive care unit admission after surgery to hospital discharge, up to 30 days)
- New onset atrial fibrillation(From intensive care unit admission after surgery to hospital discharge, up to 30 days)
- Acute kidney injury risk(Measured 4 hours after the end of cardiopulmonary bypass, up to 12 hours)
- Stroke(From intensive care unit admission after surgery to hospital discharge, up to 30 days)
- Duration of mechanical ventilation(From intensive care unit admission after surgery to hospital discharge, up to 30 days)
- Post-operative delirium(From intensive care unit admission after surgery to hospital discharge, up to 30 days)
- Post-operative hospital length of stay(From intensive care unit admission after surgery to hospital discharge, up to 30 days)
- New requirement for mechanical circulatory support(From intensive care unit admission after surgery to hospital discharge, up to 30 days)
- Intra-operative red blood cell transfusion(During the intra-operative time period, up to 12 hours)
- Post-operative red blood cell transfusion(From intensive care unit admission after surgery to hospital discharge, up to 30 days)
- Post-operative platelet transfusion(From intensive care unit admission after surgery to hospital discharge, up to 30 days)
- Post-operative plasma transfusion(From intensive care unit admission after surgery to hospital discharge, up to 30 days)
- New onset of left ventricular diastolic dysfunction(From intensive care unit admission after surgery to hospital discharge, up to 30 days)
- New onset of left ventricular systolic dysfunction(From intensive care unit admission after surgery to hospital discharge, up to 30 days)
- New onset of right ventricular systolic dysfunction(From intensive care unit admission after surgery to hospital discharge, up to 30 days)
- Post-operative cryoprecipitate transfusion(From intensive care unit admission after surgery to hospital discharge, up to 30 days)
- Intra-operative plasma transfusion(During the intra-operative time period, up to 12 hours)
- Intra-operative platelet transfusion(During the intra-operative time period, up to 12 hours)
- New onset of acute lung injury(From intensive care unit admission after surgery to hospital discharge, up to 30 days)
- Intra-operative cryoprecipitate transfusion(During the intra-operative time period, up to 12 hours)
- Glycocalyx thickness(Start of the intra-operative period to 24 hours after intensive care unit admission)
- Microvascular circulatory function(Start of the intra-operative period to 24 hours after intensive care unit admission)