Rule of Carbone Monoxyde in the Ex Vivo Lung Perfusion Reconditionning

NCT ID: NCT02032082

Last Updated: 2016-03-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2018-01-31

Brief Summary

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.

Conditions

Neurogenic Lung Edema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Ex vivo without CO

Group Type: NO_INTERVENTION

No interventions assigned to this group

EX Vivo with carbone monoxide

During the Ex Vivo Lung Perfusion reconditioning,the lungs will be ventilated wit h Oxygen (21%) and Carbon Monoxide (250ppm).

Group Type: EXPERIMENTAL

Carbone monoxide

Intervention Type: OTHER

Interventions

Carbone monoxide

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

Lung Edema

Exclusion Criteria

Infection Severe Emphysema Tumor

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital of Mont-Godinne

OTHER

Sponsor Role: lead

Responsible Party

Asmae Belhaj

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

CHU Mont-Godinne

Yvoir, Namur, Belgium

Countries

Belgium

Other Identifiers

EVLP-CO

Identifier Type: -

Identifier Source: org_study_id