Neurogenic Lung Edema Clinical Trial
Ex vivo lung perfusion (EVLP) is not a new concept and has been widely used to study lung
function in small animals. It also has been shown to be a useful technique to evaluate lungs
from donation after cardiac death (DCD) (Yeung, Thorac Surg Clin, 2009). It has been
recently demonstrated successful application of an acellular EVLP technique in optimalizing
lung function ex vivo for an extended period of time. Following 12 h of normothermic EVLP,
patients were transplanted and demonstrated immediate life-sustaining function with
promising short-term evolution (Aigner, Am J Transplant, 2012; Sanchez, J Heart Lung
Transplant, 2012; Cypel, N Engl J Med, 2011).
Lung donation obtained after carbon monoxide intoxication has been recognized as excellent
organs because of less general inflammation and less primary graft dysfunction after
procedure. In a murine model of brain dead, carbon monoxide inhalation at a low
concentration (50 to 500 parts per million (ppm)) exerts significant cytoprotection in
several lung injury models via its vasodilatation, anti-inflammatory, and anti-apoptotic
properties (Dong, J Heart Lung transplant, 2010). The carbon monoxide inhalation
down-regulates pro-inflammatory cytokines (TNF-alpha, IL-6) along with the increase of
anti-inflammatory cytokine (IL-10) in recipient serum. The inhalation significantly
decreases cell apoptosis in lung grafts, inhibiting mRNA and protein expression of
intercellular adhesion molecule-1 (ICAM-1) and caspase-3 in lung grafts (Zhou, Chin Med J,
2008).
Apoptotis and inflammatory processes may, in part, concern alveolar tissue. Research in the
field of biomarkers is now opening new perspectives with the development of non-invasive
tests allowing for monitoring inflammation and damage in the deep lung. Blood tests
(Bernard, Toxicol Appl Pharmacol, 2005) measuring lung-specific proteins (pneumoproteins)
such as Clara cell protein (CC16) and surfactant-associated proteins (A, B or D) are now
available to evaluate the permeability and/or the cellular integrity of the pulmonary
epithelium. These dosages may constitute an interesting way for monitoring the quality of
the lung before implantation.
| Status | Active, not recruiting |
| Enrollment | 40 |
| Est. completion date | January 2018 |
| Est. primary completion date | January 2018 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 5 Years to 65 Years |
| Eligibility |
Inclusion Criteria: Lung Edema Exclusion Criteria: Infection Severe Emphysema Tumor |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Belgium | CHU Mont-Godinne | Yvoir | Namur |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital of Mont-Godinne |
Belgium,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incidence on Primary Graft Dysfunction | Up to 2 years | No |