VASCULUX-examination of the Pulmonary VASCUlar Barrier in Patients During LUng Transplantation

NCT ID: NCT02225249

Last Updated: 2014-08-26

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2017-07-31

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.

Conditions

End Stage Chronic Obstructive Airways Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ludwig-Maximilians - University of Munich

OTHER

Sponsor Role: lead

Responsible Party

Dirk Bruegger MD

PD Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dirk Bruegger, MD

Role: PRINCIPAL_INVESTIGATOR

Medical Faculty of Ludwig-Maximilians-University Munich

Locations

University Hospital of Munich

Munich, Bavaria, Germany

Countries

Germany

Central Contacts

Dirk Bruegger, MD

Role: CONTACT

dirk.bruegger@med.uni-muenchen.de

+4989440076414

Thomas Irlbeck, MD

Role: CONTACT

thomas.irlbeck@med.uni-muenchen.de

+4989440073407

Facility Contacts

Dirk Bruegger, MD

Role: primary

dirk.bruegger@med.uni-muenchen.de

+4989440076414

Other Identifiers

250-14

Identifier Type: -

Identifier Source: org_study_id