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Rule of Carbone Monoxyde in the Ex Vivo Lung Perfusion Reconditionning

Primary Purpose

Neurogenic Lung Edema

Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Carbone monoxide
Sponsored by
University Hospital of Mont-Godinne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Neurogenic Lung Edema

Eligibility Criteria

5 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Lung Edema

Exclusion Criteria:

Infection Severe Emphysema Tumor

Sites / Locations

  • CHU Mont-Godinne

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Ex vivo without CO

EX Vivo with carbone monoxide

Arm Description

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

Outcomes

Primary Outcome Measures

Incidence on Primary Graft Dysfunction

Secondary Outcome Measures

Full Information

First Posted
January 8, 2014
Last Updated
March 13, 2016
Sponsor
University Hospital of Mont-Godinne
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1. Study Identification

Unique Protocol Identification Number
NCT02032082
Brief Title
Rule of Carbone Monoxyde in the Ex Vivo Lung Perfusion Reconditionning
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
January 2018 (Anticipated)
Study Completion Date
January 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital of Mont-Godinne

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurogenic Lung Edema

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ex vivo without CO
Arm Type
No Intervention
Arm Title
EX Vivo with carbone monoxide
Arm Type
Experimental
Arm Description
During the Ex Vivo Lung Perfusion reconditioning,the lungs will be ventilated wit h Oxygen (21%) and Carbon Monoxide (250ppm).
Intervention Type
Other
Intervention Name(s)
Carbone monoxide
Primary Outcome Measure Information:
Title
Incidence on Primary Graft Dysfunction
Time Frame
Up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Lung Edema Exclusion Criteria: Infection Severe Emphysema Tumor
Facility Information:
Facility Name
CHU Mont-Godinne
City
Yvoir
State/Province
Namur
ZIP/Postal Code
5530
Country
Belgium

12. IPD Sharing Statement

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Rule of Carbone Monoxyde in the Ex Vivo Lung Perfusion Reconditionning

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