The Effect of Balanced Crystalloid Versus 5% Albumin on Endothelial Glycocalyx Degradation in Patients Undergoing Off-pump Coronary Artery Bypass Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Plasma concentration of Syndecan-1
研究概览
简要总结
It is being revealed that the more severe the damage of the endothelial glycocalyx (EG) layer, the more likely it is that the prognosis of the patients is poor. For that reason, research is being actively conducted on methods for reducing damage and promoting recovery of the EG layer.The natural regeneration process of the EG layer is up to 7 days. Considering the fact that it is quiet slow, reducing the damage of EG layer is considered to be very important for improving the prognosis of patients undergoing surgery, but there is no clinically proven method.
One of the ways receiving attention to reduce damage of EG layer is to stabilize the layer through fluid therapy with albumin. The purpose of this study is to compare the protective effect of the EG layer according to the type of fluid (balanced crystalloid solution vs. 5% albumin) during surgery in patients undergoing off-pump coronary artery bypass surgery.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
One researcher (Anesthesiologist) conducts randomized group assignment, and the researcher is not involved in other aspects of anesthesia and research.
Therefore, other researchers, and all those involved in anesthesia, surgery, and postoperative management do not know the patient's group assignment.
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 20 years of age undergoing off-pump coronary artery bypass surgery
排除标准
- •Emergency operation
- •Minimally-invasive surgery (under one-lung ventilation)
- •Chronic kidney disease (eGFR<30 ml/min/1.73m2) or Dialysis
- •Acute kidney injury
- •Infectious disease
- •Preoperative steroid use
- •Malignancy
- •Reported allergic reaction to albumin preparations
- •Patients who participated in other clinical studies that could affect prognosis
- •Patients who have difficulty in reading the informed consent and voluntarily agreeing to participate in the study
研究组 & 干预措施
Plasma A group
The group receiving balanced crystalloid solution (Plasma solution-A injection, CJ Pharma, South Korea) during surgery
干预措施: Plasma solution-A injection (Drug)
Albumin group
The group receiving receiving 5% albumin (Albumin 5% inj, Green cross, South Korea) during surgery
干预措施: 5% Albumin (Drug)
结局指标
主要结局
Plasma concentration of Syndecan-1
时间窗: At the time of sternum being closed (30min~1hr before the end of surgery)
The investigators compare the protective effect of EG layer according to the type of fluid used during surgery in patients undergoing off-pump coronary artery bypass surgery. (Comparison of the plasma concentration of Syndecan-1 between the two groups.)
次要结局
- Plasma concentration of Haparan sulfate(At the time of sternum being closed (30min~1hr before the end of surgery))
- Plasma concentration of ANP(At the time of returning the heart in place after coronary artery anastomoses (1~2hr before the end of surgery))
- Plasma concentration of TNF-α/IL-6(At the time of sternum being closed (30min~1hr before the end of surgery))
- Composite rate of morbidity and mortality(If the hospitalization period exceeds 30 days, follow-up is done throughout the hospitalization period.)