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

Examination of the Pulmonary Vascular Barrier in Patients During Lung Transplantation

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.

Study Overview

• Status: Unknown
• Conditions: End Stage Chronic Obstructive Airways Disease

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.

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

Study Locations

• Germany
  • Bavaria
    • Munich, Bavaria, Germany, 81377
      • University Hospital of Munich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).
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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Ludwig-Maximilians - University of Munich
• Investigators: Principal Investigator: Dirk Bruegger, MD, Medical Faculty of Ludwig-Maximilians-University Munich

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Anticipated): October 1, 2016
• Study Completion (Anticipated): July 1, 2017

Study Registration Dates

• First Submitted: August 4, 2014
• First Submitted That Met QC Criteria: August 22, 2014
• First Posted (Estimate): August 26, 2014

Study Record Updates

• Last Update Posted (Estimate): August 26, 2014
• Last Update Submitted That Met QC Criteria: August 22, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 250-14