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

End Stage Chronic Obstructive Airways Disease Clinical Trial

— VASCULUX  

Official title:

Examination of the Pulmonary Vascular Barrier in Patients During Lung Transplantation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02225249
• Other study ID #: 250-14
• Status: Not yet recruiting
• Phase: N/A
• First received: August 4, 2014
• Last updated: August 22, 2014
• Start date: October 2014
• Est. completion date: July 2017

Study information

• Verified date: August 2014
• Source: Ludwig-Maximilians - University of Munich
• Contact: Dirk Bruegger, MD
• Phone: +4989440076414
• Email: dirk.bruegger[@]med.uni-muenchen.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: July 2017
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• End Stage Chronic Obstructive Airways Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
Germany	University Hospital of Munich	Munich	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Ludwig-Maximilians - University of Munich

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Components of the vascular barrier	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]: Syndecan-1 [ng/ml]; Hyaluronan [ng/ml]; Heparan-Sulphate [ng/ml]; Angiopoetin-1 [ng/ml]; Angiopoetin-2 [ng/ml]; Components getting measured using serum or plasma samples.	Repeated mesurements to detect differences from baseline values (T0).	No
Primary	Extravascular Lung Water Index (ELWI)	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]	repeated measurement of ELWI to detect differences from baseline (T0)	No
Secondary	Clinical parameters	Follwowing clinicals parameters will be assessed at eacht time point to detect increases or decreases from baseline [Units]: Each parameter will be assessed at time point: T0, T1, T2, T3, T4, T5, T6, T7; Oxygenation index [mmHg/FiO2]; Heart rate [beats per min]; Systolic blood pressure [mmHg]; Mean arterial blood pressure [mmHg]; Necessity of extracorporal lung assist [yes/no]; The investigators assess clinical parameters as oxygenation index, heartrate, blood pressure.	Repeated measurement of each parameter to detect differences from baseline (T0)	No