Evaluation of Damaging Factors to Endothelial Glycocalyx During On-pump Coronary Artery Bypass Surgery Using Syndecan-1 Biomarker.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 147
- 试验地点
- 2
- 主要终点
- Changes of syndecan-1 concentration during surgery and postoperative period.
研究概览
简要总结
Evaluation of endothelial glycocalyx damage in on-pump conventional coronary artery bypass surgery using a syndecan-1 (CD138) blood test. The study will be carried out in two stages. Pilot study for testing and correcting research methodology and the main study.
详细描述
Study tasks:
- To evaluate changes of syndecan-1 concentration during surgery and postoperative period.
- Determine the effect of aortic clamping and on-pump duration on endothelial glycocalyx damage.
- Assess the risk of early postoperative complications and syndecan-1 plasma concentrations.
- To evaluate the correlation of inflammatory status with glycocalyx damage.
- To evaluate glycocalyx damage to patients with diabetes vs non-diabetes.
Methods:
Patients undergoing cardiopulmonary bypass surgery are being treated at the Heart, Chest and Vascular Surgery Clinic of the Lithuanian University of Health Sciences Hospital in Kaunas Clinics. After receiving patients written consent a syndecan-1 concentration test will be performed upon arrival at the operating room, before cardiopulmonary bypass (CPB), after CPB, upon arrival in the ICU and after 24 hours.
All needed data for evaluating patients outcome will be taken from medical documentation during patients stay in hospital.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective on-pump coronary artery bypass surgery needed.
- •Normal heart function at the time of operation.
- •Patients without infections.
- •Patients who signed study informed consent form
排除标准
- •Life saving operation.
- •Renal or hepatic dysfunction.
- •Off-pump heart operation.
结局指标
主要结局
Changes of syndecan-1 concentration during surgery and postoperative period.
时间窗: 2 years
Concentration of syndecan-1 will be measured by taking patients blood sample before operation, after aortic cannulation, after CPB, when arriving to ICU and 24 hours after operation. Means of concentration changes will be compared to determine which period of operation has the biggest impact to endothelial glycocalyx shedding.
Glycocalyx damage to patients with diabetes vs non-diabetes during heart surgery.
时间窗: 2 years
Compare glycocalyx damage using syndecan-1 concentration changes to diabetic and non-diabetic patents during heart surgery.
Assess the risk of early postoperative complications and find possible correlation to syndecan-1 concentration changes.
时间窗: 2 years
All negative events after operation will be recorded and statistically correlated with syndecan-1 concentration changes.
The correlation of inflammatory status with glycocalyx damage.
时间窗: 2 years
Leucocytosis and C reactive protein levels will be evaluated before, after heart operation and 24 hours later. Data will be compared to syndecan-1 concentration changes.
The evaluation of aortic clamping and on-pump duration on endothelial glycocalyx damage using syndecan-1 concentration measure.
时间窗: 2 years
Concentrations of syndecan-1 will be evaluated considering the duration of aortic clamping and CPB. Optimal duration will be searched for minimal impact to endothelial glycocalyx.
次要结局
未报告次要终点
研究者
Tadas Cesnaitis
PhD student
Lithuanian University of Health Sciences