Ischemia-Reperfusion Injury Clinical Trial
Official title:
Inhaled Nitric Oxide in Prevention/Treatment of Ischemia-Reperfusion Lung Injury Related to Lung Transplantation
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
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