End Stage Chronic Obstructive Airways DiseaseVASCULUXNCT02225249
VASCULUX-examination of the Pulmonary VASCUlar Barrier in Patients During LUng Transplantation
An observational study of End Stage Chronic Obstructive Airways Disease, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- End Stage Chronic Obstructive Airways Disease
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2014to Jul 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Eligible for this study are all patients being full of age and younger than 65 years scheduled for lung transplantation
Who may be able to join
- At least 18 and younger than 65 years of age
- Scheduled for lung transplantation
Who cannot join
- Pregnancy
- Necessity of ECMO implementation before induction of general anesthesia
- Mechanical ventilation before lung transplantation
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital of Munich
Munich, Bavaria, 81377
Dirk Bruegger, MD, +4989440076414, dirk.bruegger@med.uni-muenchen.de
Dirk Bruegger, MD
About this study
Official title: 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.
Read the 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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]
Measured: repeated measurement of ELWI to detect differences from baseline (T0)
Secondary outcomes (1)
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.
Measured: Repeated measurement of each parameter to detect differences from baseline (T0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2014 (estimated)
- Study startOct 2014
- Primary completionOct 2016 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Chronic Obstructive Airways DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dirk Bruegger MD, Ludwig-Maximilians - University of Munich
- Investigators
- Dirk Bruegger, MD, Principal investigator, Medical Faculty of Ludwig-Maximilians-University Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02225249
- Sponsor's protocol ID
- 250-14
- Acronym
- VASCULUX
- Status last verified
- Aug 2014
- First submitted
- 4 Aug 2014
- Last updated
- 26 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of the Pulmonary Vascular Barrier in Patients During Lung Transplantation
- ClinicalTrials.gov ID
- NCT02225249
- Acronym / sponsor ID
- VASCULUX / 250-14
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 26 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible for this study are all patients being full of age and younger than 65 years scheduled for lung transplantation
Key inclusion criteria (2 listed)
- At least 18 and younger than 65 years of age
- Scheduled for lung transplantation
Key exclusion criteria (3 listed)
- Pregnancy
- Necessity of ECMO implementation before induction of general anesthesia
- Mechanical ventilation before lung transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Components of the vascular barrier
Time frame: Repeated mesurements to detect differences from baseline values (T0).
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.
Extravascular Lung Water Index (ELWI)
Time frame: repeated measurement of ELWI to detect differences from baseline (T0)
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]
1 secondary outcome
Clinical parameters
Time frame: Repeated measurement of each parameter to detect differences from baseline (T0)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dirk Bruegger, MD principal investigator
Medical Faculty of Ludwig-Maximilians-University Munich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of End Stage Chronic Obstructive Airways Disease, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dirk Bruegger, MD (+4989440076414, dirk.bruegger@med.uni-muenchen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Components of the vascular barrier (time frame: Repeated mesurements to detect differences from baseline values (T0).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2014.