Ex Vivo Lung Perfusion : Effect of Cellular Perfusate on Mechanical Properties and Gas Exchange Function of Donor Lungs
Study Details
Study Description
Brief Summary
The lungs retrieved from the brain dead multi organ donor will be placed in a lab . They will be connected to a ventilator and preservative solution will be circulated through it . Blood will be added to the fluid depending on the group to which the lungs are allocated and its effects on lung function will be seen
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The lungs of a brain dead multi organ donor will be retrieved according to standard protocol. Once a decision is made not to transplant the lungs either because of not satisfying ideal criteria or in the absence of a potential recipient they will be included in the study.They will be ventilated optimally and connected to a cardiopulmonary bypass machine for circulating preservative solution through it . Red blood cells will be added to the solution either initially or later depending on the group to which it is allocated .Monitoring of mechanical and gas exchange function and pathological examination of the lungs will be performed at various time points to observe the effect of red blood cells. The lungs will be properly discarded at the end of the procedure and will not be used for transplantation.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Acellular first Lung preservative solution without red blood cells will be used for perfusion in the initial 2 hours followed by addition of red blood cells for the next two hours |
Other: Red blood cells
Packed red blood cells to final hematocrit of 14%
|
| Experimental: Cellular first Lung preservative solution will contain red blood cells for the first two hours followed by acellular perfusate for the next two hours |
Other: Red blood cells
Packed red blood cells to final hematocrit of 14%
|
Outcome Measures
Primary Outcome Measures
- Compliance [From beginning of perfusion to 4 hours after that]
Measured from the airway pressure on ventilator
Secondary Outcome Measures
- Partial pressure to Inspired oxygen concentration ratio [From beginning of perfusion to 4 hours after that]
Ratio of partial pressure of oxygen in perfusate to fraction of inspired oxygen
- Pulmonary vascular resistance [From beginning of perfusion to 4 hours after that]
Calculated from measured pulmonary artery pressure and pump flow
- Lung injury score [From beginning of perfusion to 4 hours after that]
By pathological examination
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Brain death certified multi organ donor
-
Absence of ideal lung donor criteria or absence of suitable lung recipient
Exclusion Criteria:
-
presence of severe mechanical lung injury on visual inspection or radiography
-
Presence of pneumonia
-
Positive serology ( Hepatitis B,C and HIV
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Postgraduate Institute of Medical Education and Research | Chandigarh | India | 160012 |
Sponsors and Collaborators
- Postgraduate Institute of Medical Education and Research
Investigators
- Study Director: Goverdhan D Puri, MD, PhD, Postgraduate Institute of Medical Education and Research
Study Documents (Full-Text)
None provided.More Information
Publications
- Cypel M, Yeung JC, Liu M, Anraku M, Chen F, Karolak W, Sato M, Laratta J, Azad S, Madonik M, Chow CW, Chaparro C, Hutcheon M, Singer LG, Slutsky AS, Yasufuku K, de Perrot M, Pierre AF, Waddell TK, Keshavjee S. Normothermic ex vivo lung perfusion in clinical lung transplantation. N Engl J Med. 2011 Apr 14;364(15):1431-40. doi: 10.1056/NEJMoa1014597.
- Yeung JC, Cypel M, Machuca TN, Koike T, Cook DJ, Bonato R, Chen M, Sato M, Waddell TK, Liu M, Slutsky AS, Keshavjee S. Physiologic assessment of the ex vivo donor lung for transplantation. J Heart Lung Transplant. 2012 Oct;31(10):1120-6. doi: 10.1016/j.healun.2012.08.016.
- 10735-PG-1Trg-15/4913-14