Inhaled Nitric Oxide in Prevention/Treatment of Ischemia-Reperfusion Lung Injury Related to Lung Transplantation

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effects of inhaled nitric oxide on both short-term physiology as well as on the development of ischemia-reperfusion lung injury (IRLI) in the immediate post transplant period. The specific hypothesis is that inhaled NO post lung transplantation will improve gas exchange/hemodynamic and thus reduce the development of post transplant IRLI.

Detailed Description
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The objective is to determine the role of inhaled NO in the prevention/treatment of IRLI in lung transplant patients. The plan is to accomplish this objective in 2 phases: Phase 1 - patients immediately post transplant will have a variety of physiologic measurements performed while breathing 0, 10, and 20 ppm inhaled NO. For the next 24 hours they will be kept on a mixture providing the best oxygen delivery and pulmonary artery pressure. Our specific aims in this phase are to characterize physiologic responses to inhaled NO and determine the incidence of IRLI in these patients over 24 hours. Phase 2 - patients immediately post transplant will be randomized to either INO or placebo gas and followed for 24 hours. Our specific aim in this phase is to compare the rate of development of IRLI in the two groups.

Official Title
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Inhaled Nitric Oxide in Prevention/Treatment of Ischemia-Reperfusion Lung Injury Related to Lung Transplantation

Conditions
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Ischemia-Reperfusion Injury

Intervention / Treatment
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* Drug: nitric oxide for inhalation
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Patients undergoing lung transplantation Exclusion criteria: Participation in other experimental protocols

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Inhaled Nitric Oxide | Drug: nitric oxide for inhalation<br>* Either 10 or 20 ppm of inhaled nitric oxide for 24 hour post transplant<br>* Other names: INOmax®;|
| Placebo Comparator: 2<br>Placebo gas | Drug: Placebo<br>* Placebo gas will be given at 10 or 20 ppm for 24 hours post transplant<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| arterial and mixed venous blood gases |  | first 4 hours post transplant | 
| pulmonary vascular pressures |  | first 4 hours post transplant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardiac output |  | first 4 hours post transplant | 
| systemic hemodynamics |  | first 4 hours post transplant | 
| NO2 and NO concentrations |  | duration of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ischemia-reperfusion lung injury, IRLI