Rule of Carbone Monoxyde in the Ex Vivo Lung Perfusion Reconditionning

Not Applicable

• Conditions: Neurogenic Lung Edema
• Interventions: Other: Carbone monoxide

• Registration Number: NCT02032082
• Lead Sponsor: University Hospital of Mont-Godinne

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-08
• Study First Submitted QC: 2014-01-08
• Study First Posted: 2014-01-09
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-13
• Last Update Posted: 2016-03-15
• Primary Completion: 2018-01
• Study Completion: 2018-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Lung Edema

Exclusion Criteria

Infection Severe Emphysema Tumor

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EX Vivo with carbone monoxide	Carbone monoxide	During the Ex Vivo Lung Perfusion reconditioning,the lungs will be ventilated wit h Oxygen (21%) and Carbon Monoxide (250ppm).

Primary Outcome Measures

Name	Time	Method
Incidence on Primary Graft Dysfunction	Up to 2 years

Trial Locations

Locations (1)

CHU Mont-Godinne; 🇧🇪 Yvoir, Namur, Belgium