Exhaled Breath Particles in Lung Transplantation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16-75
SponsorLund University Hospital
About this trial
Lung transplantation (LTx) is the only effective treatment for patients with end stage lung disease. Of the major organs transplanted, survival following LTx is the lowest with a mean of 5 years. Despite improvements, primary graft dysfunction (PGD) remains the leading cause of early mortality and contributes to the development of chronic lung allograft dysfunction (CLAD) that remains the leading cause of late mortality. Earlier detection of rejection after LTx is of substantial importance as it would improve the possibilities of treatment and could increase survival.
The investigators have shown in previous work that exhaled breath particles (EBP) reflect the composition of respiratory tract lining fluid (RTLF). EBP and particle flow rate (PFR) can be used as non-invasive methods for early detection and monitoring of airway diseases such as acute respiratory distress syndrome (ARDS). It has also been shown that the particle flow prolife after lung transplantation differs between patients who develop PGD and those who do not and that the composition of EBP differs between patients with and without bronchiolitis obliterans syndrome (BOS), an obstructive form of CLAD.
Samples of EBP and measurements of PFR will be collected from lung transplanted patients. Membranes with EBP will be saved for molecular analysis. The investigators aim to identify potential particle flow patterns and biomarkers for earlier detection of rejection after lung transplantation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients who have undergone LTx at Skåne University Hospital, SUS Lund
Disqualifiers
None
Trial population
Patients undergoing lung transplantation at Skåne University Hospital, SUS Lund.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
150 Participants
are grouped into 2 trial groupsGroup A: LTx rejection
Group B: LTx non-rejection
Trial outcomes
Primary outcomes
1
Concentration of proteins in EBP
Proteins from exhaled air are collected onto a membrane for subsequently molecular analysis. Analysis aims to identify candidate biomarker for acute and chronic rejection of transplanted lungs.
Time frame
Pre-transplantation2
Concentration of proteins in EBP
Proteins from exhaled air are collected onto a membrane for subsequently molecular analysis. Analysis aims to identify candidate biomarker for acute and chronic rejection of transplanted lungs.
Time frame
Day 1-3 after lung transplantation3
Concentration of proteins in EBP
Proteins from exhaled air are collected onto a membrane for subsequently molecular analysis. Analysis aims to identify candidate biomarker for acute and chronic rejection of transplanted lungs.
Time frame
1 month after lung transplantation4
Concentration of proteins in EBP
Proteins from exhaled air are collected onto a membrane for subsequently molecular analysis. Analysis aims to identify candidate biomarker for acute and chronic rejection of transplanted lungs.
Time frame
3 months after lung transplantationSecondary outcomes
1
Concentration of proteins and other biomarkers in plasma
Concentration and composition of proteins and other biomarkers will be analysed in plasma
Time frame
Pre-transplantation2
Concentration of proteins and other biomarkers in plasma
Concentration and composition of proteins and other biomarkers will be analysed in plasma
Time frame
Day 1 after lung transplantation3
Concentration of proteins and other biomarkers in plasma
Concentration and composition of proteins and other biomarkers will be analysed in plasma
Time frame
Day 2 after lung transplantation4
Concentration of proteins and other biomarkers in plasma
Concentration and composition of proteins and other biomarkers will be analysed in plasma
Time frame
Day 3 after lung transplantationSponsors and contacts
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Source ClinicalTrials.gov