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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
84
Either 10 or 20 ppm of inhaled nitric oxide for 24 hour post transplant
Placebo gas will be given at 10 or 20 ppm for 24 hours post transplant
Duke University Medical Center
Durham, North Carolina, United States
arterial and mixed venous blood gases
Time frame: first 4 hours post transplant
pulmonary vascular pressures
Time frame: first 4 hours post transplant
cardiac output
Time frame: first 4 hours post transplant
systemic hemodynamics
Time frame: first 4 hours post transplant
NO2 and NO concentrations
Time frame: duration of treatment
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