Clinical trial NCT02225249: VASCULUX-examination of the Pulmonary VASCUlar Barrier in Patients During LUng Transplantation
Official title: Examination of the Pulmonary Vascular Barrier in Patients During Lung Transplantation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: End Stage Chronic Obstructive Airways Disease
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
First posted: 2014-08-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible for this study are all patients being full of age and younger than 65 years scheduled for lung transplantation

Brief summary: 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.

Detailed description: 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.

To quantify the extent of damage the investigators seek to evaluate the correlation between ELWI and the damage to the vascular barrier. ELWI will be assessed using transpulmonary thermodilution. Components of the vascular barrier will be quantified using ELISA-technique. 10 ml full blood will be drawn at 7 different predifined measurement points named T0-T7 as follows:

* T0 before induction of anesthesia
* T1 before reperfusion of the first lung
* T2 5 min after reperfusion of the first lung
* T3 before reperfusion of the second lung
* T4 5 min after reperfusion of the second lung
* T5 before admission to the intensive care unit
* T6 6h after reperfusion of the last lung
* T7 12h after reperfusion of the last lung

For statistical analysis Student's t-test, Friedman or Wilcoxon rank test will be used, as indicated.

Expected length of the study is 2 years enrolling 30 patients undergoing lung transplantation.

Eligibility criteria: Inclusion Criteria:

* At least 18 and younger than 65 years of age
* Scheduled for lung transplantation

Exclusion Criteria:

* Pregnancy
* Necessity of ECMO implementation before induction of general anesthesia
* Mechanical ventilation before lung transplantation

Primary outcomes:
measure: Components of the vascular barrier
timeFrame: Repeated mesurements to detect differences from baseline values (T0).
measure: Extravascular Lung Water Index (ELWI)
timeFrame: repeated measurement of ELWI to detect differences from baseline (T0)
Secondary outcomes:
measure: Clinical parameters
timeFrame: Repeated measurement of each parameter to detect differences from baseline (T0)
Other outcomes:
Locations:
city: Munich
country: Germany
facility: University Hospital of Munich
state: Bavaria
Study officials:
affiliation: Medical Faculty of Ludwig-Maximilians-University Munich
name: Dirk Bruegger, MD
role: PRINCIPAL_INVESTIGATOR
References: