Comparison of the Effects of Minimally Invasive and Conventional Extracorporeal Circulation on Systemic Inflammation Indices in Coronary Artery Bypass Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Neutrophil-to-Lymphocyte Ratio (NLR)
研究概览
简要总结
This prospective observational study evaluates the effects of minimally invasive extracorporeal circulation (MIECC) and conventional cardiopulmonary bypass on systemic inflammatory response in patients undergoing coronary artery bypass graft surgery. Adult patients undergoing elective coronary artery bypass surgery will be observed according to the extracorporeal circulation technique used during surgery. Systemic inflammation will be assessed using routinely available hematologic inflammatory indices, including the neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), and systemic immune-inflammation index (SII). These parameters will be evaluated preoperatively, at postoperative 6 hours, at postoperative 24 hours, and at hospital discharge. The study will also evaluate selected perioperative and postoperative clinical outcomes in order to compare the inflammatory response associated with MIECC and conventional extracorporeal circulation.
详细描述
Coronary artery bypass graft surgery performed with cardiopulmonary bypass is associated with activation of systemic inflammatory pathways. Contact of blood with the extracorporeal circuit, surgical trauma, ischemia-reperfusion injury, and perioperative factors may contribute to this response. Minimally invasive extracorporeal circulation systems are designed to reduce blood-air contact, circuit surface area, and hemodilution and may therefore attenuate the inflammatory response compared with conventional cardiopulmonary bypass.
In this prospective observational study, patients undergoing elective coronary artery bypass graft surgery will be evaluated according to whether minimally invasive extracorporeal circulation or conventional extracorporeal circulation is used during surgery. No treatment assignment will be made by the study protocol.
Inflammatory response will be assessed using neutrophil-to-lymphocyte ratio, platelet-to-lymphocyte ratio, and systemic immune-inflammation index calculated from routinely obtained laboratory measurements. Measurements will be evaluated preoperatively, at 6 hours after surgery, at 24 hours after surgery, and at hospital discharge. Perioperative variables and postoperative clinical outcomes will also be recorded for comparison between the two groups.
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
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 30-70 years
- •Patients undergoing elective coronary artery bypass graft surgery
- •Patients in whom cardiopulmonary bypass is planned
- •Written informed consent obtained
排除标准
- •Emergency surgery
- •Redo cardiac surgery
- •Concomitant valve surgery
- •Previous open heart surgery
- •Preoperative renal and/or hepatic failure
- •Malignancy
- •Active infection or inflammatory disease-
研究组 & 干预措施
MIECC Group
Patients undergoing coronary artery bypass graft surgery using minimally invasive extracorporeal circulation (MIECC) as part of routine clinical care.
干预措施: Minimally Invasive Extracorporeal Circulation (Procedure)
Conventional Cardiopulmonary Bypass Group
Patients undergoing coronary artery bypass graft surgery using conventional cardiopulmonary bypass as part of routine clinical care.
干预措施: Conventional Cardiopulmonary Bypass (Procedure)
结局指标
主要结局
Neutrophil-to-Lymphocyte Ratio (NLR)
时间窗: Preoperative baseline, 6 hours after surgery, 24 hours after surgery, and on the morning of hospital discharge, an average of 6 days after surgery.
NLR will be calculated from routine complete blood count values by dividing the absolute neutrophil count by the absolute lymphocyte count. Values will be compared between the MIECC and conventional cardiopulmonary bypass groups.
Platelet-to-Lymphocyte Ratio (PLR)
时间窗: Preoperative baseline, 6 hours after surgery, 24 hours after surgery, and on the morning of hospital discharge, an average of 6 days after surgery.
PLR will be calculated from routine complete blood count values by dividing the platelet count by the absolute lymphocyte count. Values will be compared between the MIECC and conventional cardiopulmonary bypass groups.
Systemic Immune-Inflammation Index (SII)
时间窗: Preoperative baseline, 6 hours after surgery, 24 hours after surgery, and on the morning of hospital discharge, an average of 6 days after surgery.
SII will be calculated as neutrophil count × platelet count / lymphocyte count using routine complete blood count values. Values will be compared between the MIECC and conventional cardiopulmonary bypass groups.
次要结局
未报告次要终点
研究者
Umran Karaca
Associate Professor of Anesthesiology and Reanimation
Bursa Yuksek Ihtisas Training and Research Hospital