Nitric Oxide |
INOmax |
Clinical Trial: Inhaled Nitric Oxide in Prevention/Treatment of Ischemia-Reperfusion Lung Injury Related to Lung Transplantation
This study is currently recruiting patients.
|
Purpose
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.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Ischemia-Reperfusion Injury | Drug: INOmax (nitric oxide for inhalation) | Phase III |
MedlinePlus related topics: Vascular Diseases
Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
Expected Total Enrollment: 120
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.
Eligibility
Genders Eligible for Study: Both
Criteria
Inclusion criteria:
- Patients undergoing lung transplantation
Exclusion criteria:
- Participation in other experimental protocols
Location and Contact Information
North Carolina
Duke University Medical Center, Durham, North Carolina, 27710, United States; Recruiting
More Information
Record last reviewed: February 2005
Last Updated: February 7, 2005
Record first received: May 6, 2003
ClinicalTrials.gov Identifier: NCT00060450
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- INOmax (Drug Digest)
- Nitric Oxide (Drug Digest)

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