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

NCT02225249 | Unknown

• 1 other identifier: 250-14
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

End Stage Chronic Obstructive Airways Disease

Outcome Measures

Primary Outcomes (2)

• 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 \[Unit\]: 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.

  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 Outcomes (1)

• Clinical parameters

  Repeated measurement of each parameter to detect differences from baseline (T0)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ludwig-Maximilians - University of Munich: lead

Study Sites (1)

University Hospital of Munich

Munich, Bavaria, 81377, Germany

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be taken. In summary, 61.2 ml blood will be collected at 7 specific time points. Components of the vascular barrier are examined, in detail hyaluronan, syndecan-1, and angiopoietin-2.

Study Officials

• Dirk Bruegger, MD

  Medical Faculty of Ludwig-Maximilians-University Munich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dirk Bruegger, MD

CONTACT

+4989440076414; dirk.bruegger@med.uni-muenchen.de

Thomas Irlbeck, MD

CONTACT

+4989440073407; thomas.irlbeck@med.uni-muenchen.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr.

Study Record Dates

• First Submitted: August 4, 2014
• First Posted: August 26, 2014
• Study Start: October 1, 2014
• Primary Completion: October 1, 2016
• Study Completion: July 1, 2017
• Last Updated: August 26, 2014

Record last verified: 2014-08

Locations

DE (1)