Exhaled Breath Particles in Lung Transplantation

NCT05375149 | Recruiting DMC

• 1 other identifier: LTxPEx
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Transplant Rejection; Primary Graft Dysfunction; Chronic Rejection of Lung Transplant

Keywords

Exhaled Breath Particles; PExA; Lung transplantation; Primary Graft Dysfunction; Chronic Lug Allograft Dysfunction

Outcome Measures

Primary Outcomes (21)

• 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.

  Pre-transplantation

• 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.

  Day 1-3 after lung transplantation

• 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.

  1 month after lung transplantation

• 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.

  3 months after lung transplantation

• 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.

  6 months after lung transplantation

• 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.

  9 months after lung transplantation

• 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.

  12 months after lung transplantation

• 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.

  18 months after lung transplantation

• 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.

  2 years after lung transplantation

• 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.

  3 years after lung transplantation

• 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.

  4 years after lung transplantation

• Particle flow rate from the airways (PFR)

  PFR will be measured by the PExA device. The flow rate and the particle pattern will be analysed to find differences between groups of lung transplanted patients with and without rejection.

  Day 1-3 after transplantation

• Particle flow rate from the airways (PFR)

  PFR will be measured by the PExA device. The flow rate and the particle pattern will be analysed to find differences between groups of lung transplanted patients with and without rejection.

  1 month after transplantation

• Particle flow rate from the airways (PFR)

  PFR will be measured by the PExA device. The flow rate and the particle pattern will be analysed to find differences between groups of lung transplanted patients with and without rejection.

  3 months after transplantation

• Particle flow rate from the airways (PFR)

  PFR will be measured by the PExA device. The flow rate and the particle pattern will be analysed to find differences between groups of lung transplanted patients with and without rejection.

  6 months after transplantation

• Particle flow rate from the airways (PFR)

  PFR will be measured by the PExA device. The flow rate and the particle pattern will be analysed to find differences between groups of lung transplanted patients with and without rejection.

  9 months after transplantation

• Particle flow rate from the airways (PFR)

  PFR will be measured by the PExA device. The flow rate and the particle pattern will be analysed to find differences between groups of lung transplanted patients with and without rejection.

  12 months after transplantation

• Particle flow rate from the airways (PFR)

  PFR will be measured by the PExA device. The flow rate and the particle pattern will be analysed to find differences between groups of lung transplanted patients with and without rejection.

  18 months after transplantation

• Particle flow rate from the airways (PFR)

  PFR will be measured by the PExA device. The flow rate and the particle pattern will be analysed to find differences between groups of lung transplanted patients with and without rejection.

  2 years after transplantation

• Particle flow rate from the airways (PFR)

  PFR will be measured by the PExA device. The flow rate and the particle pattern will be analysed to find differences between groups of lung transplanted patients with and without rejection.

  3 years after transplantation

• Particle flow rate from the airways (PFR)

  PFR will be measured by the PExA device. The flow rate and the particle pattern will be analysed to find differences between groups of lung transplanted patients with and without rejection.

  4 years after transplantation

Secondary Outcomes (33)

• Concentration of proteins and other biomarkers in plasma

  Pre-transplantation

• Concentration of proteins and other biomarkers in plasma

  Day 1 after lung transplantation

• Concentration of proteins and other biomarkers in plasma

  Day 2 after lung transplantation

• Concentration of proteins and other biomarkers in plasma

  Day 3 after lung transplantation

• Concentration of proteins and other biomarkers in plasma

  1 month after lung transplantation

Study Arms (2)

LTx rejection

Lung transplanted patients with acute or chronic rejection

LTx non-rejection

Lung transplanted patients without any form of rejection

Eligibility Criteria

• Age: 16 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients undergoing lung transplantation at Skåne University Hospital, SUS Lund.

You may qualify if:

• Patients who have undergone LTx at Skåne University Hospital, SUS Lund

You may not qualify if:

• None

Sponsors & Collaborators

• Lund University Hospital: lead

Study Sites (1)

Skåne University Hospital

Lund, Skåne County, 224 60, Sweden

RECRUITING

Related Publications (4)

• Ericson PA, Mirgorodskaya E, Hammar OS, Viklund EA, Almstrand AR, Larsson PJ, Riise GC, Olin AC. Low Levels of Exhaled Surfactant Protein A Associated With BOS After Lung Transplantation. Transplant Direct. 2016 Aug 26;2(9):e103. doi: 10.1097/TXD.0000000000000615. eCollection 2016 Sep.

  PMID: 27795995 BACKGROUND

• Stenlo M, Hyllen S, Silva IAN, Bolukbas DA, Pierre L, Hallgren O, Wagner DE, Lindstedt S. Increased particle flow rate from airways precedes clinical signs of ARDS in a porcine model of LPS-induced acute lung injury. Am J Physiol Lung Cell Mol Physiol. 2020 Mar 1;318(3):L510-L517. doi: 10.1152/ajplung.00524.2019. Epub 2020 Jan 29.

  PMID: 31994907 BACKGROUND

• Broberg E, Hyllen S, Algotsson L, Wagner DE, Lindstedt S. Particle Flow Profiles From the Airways Measured by PExA Differ in Lung Transplant Recipients Who Develop Primary Graft Dysfunction. Exp Clin Transplant. 2019 Dec;17(6):803-812. doi: 10.6002/ect.2019.0187. Epub 2019 Oct 11.

  PMID: 31615381 BACKGROUND

• Behndig AF, Mirgorodskaya E, Blomberg A, Olin AC. Surfactant Protein A in particles in exhaled air (PExA), bronchial lavage and bronchial wash - a methodological comparison. Respir Res. 2019 Sep 26;20(1):214. doi: 10.1186/s12931-019-1172-1.

  PMID: 31558154 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Exhaled breath particles (EBP), blood samples, bronchoalveolar lavage fluid (BAL), biopsies of lung tissue

MeSH Terms

Conditions

Primary Graft Dysfunction

Condition Hierarchy (Ancestors)

Reperfusion Injury; Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sandra Lindstedt, MD, PhD

  Region Skåne, Lund University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sandra Lindstedt, MD, PhD

CONTACT

+46737220580; sandra.lindstedt_ingemansson@med.lu.se

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2022
• First Posted: May 16, 2022
• Study Start: September 18, 2018
• Primary Completion: September 1, 2024
• Study Completion (Estimated): September 1, 2026
• Last Updated: May 16, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)