Examination of the Pulmonary Vascular Barrier in Patients During Lung Transplantation
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Components of the vascular barrier
研究概览
简要总结
Lung transplantation is a well established method for surgical therapy for patients with end stage pulmonary disease.
The investigators seek to determine to which extent the pulmonary vascular barrier gets harmed during lung transplantation and whether pulmonary edema after reperfusion can be monitored with measurement of extravascular lung water index (ELWI).
Additionally the investigaors are going to evaluate the correlation between ELWI and shedding of the endothelial glycocalyx.
The study is designed as a prospective observational cohort study.
详细描述
This study is designed as a single center prospective observational cohort study including only patients who are undergoing lung transplantation due to endstage pulmonary disease.
It is well known that pulmonary edema is one of the major problems following reperfusion of the new organ.
The glycocalyx is located on the apical surface of vascular endothelial cells which line the vascular lumen. The endothelial glycocalyx consists of mainly proteoglycans that covers, among others, leukocyte and thrombocyte receptors and fulfills its principal role in maintaining plasma and vessel wall homeostasis.
In patients undergoing cardiac surgery studies showed regional as well as global ischemia causing an increase of syndecan-1 and heparansulphate in plasma during reperfusion.
The extent of the pulmonary vascular barrier's damage might serve as predictor for postoperative complications as reperfusion edema of the lungs.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 18 and younger than 65 years of age
- •Scheduled for lung transplantation
排除标准
- •Pregnancy
- •Necessity of ECMO implementation before induction of general anesthesia
- •Mechanical ventilation before lung transplantation
结局指标
主要结局
Components of the vascular barrier
时间窗: Repeated mesurements to detect differences from baseline values (T0).
Repeated measurements of each parameter to detect the difference from baseline values. Each component will be measured at time point: T0, T1, T2, T3, T4 and T5. Components to be measured \[Unit\]: 1. Syndecan-1 \[ng/ml\] 2. Hyaluronan \[ng/ml\] 3. Heparan-Sulphate \[ng/ml\] 4. Angiopoetin-1 \[ng/ml\] 5. Angiopoetin-2 \[ng/ml\] Components getting measured using serum or plasma samples.
Extravascular Lung Water Index (ELWI)
时间窗: repeated measurement of ELWI to detect differences from baseline (T0)
Increase of the Extravascular Lung Water Index (ELWI) will be determined using thermodilution-method. Repeated measurement of ELWI to detect the difference from baseline values. Each component will be measured at time point: T0, T5, T6 and T7. Unit of measurement: \[ml/kg\]
次要结局
- Clinical parameters(Repeated measurement of each parameter to detect differences from baseline (T0))
研究者
Dirk Bruegger MD
PD Dr.
Ludwig-Maximilians - University of Munich