Inhaled Nitric Oxide in Prevention/Treatment of Ischemia-Reperfusion Lung Injury Related to Lung Transplantation
NCT ID: NCT00060450
Last Updated: 2016-09-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
84 participants
INTERVENTIONAL
2001-08-31
2006-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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1
Inhaled Nitric Oxide
nitric oxide for inhalation
Either 10 or 20 ppm of inhaled nitric oxide for 24 hour post transplant
2
Placebo gas
Placebo
Placebo gas will be given at 10 or 20 ppm for 24 hours post transplant
Interventions
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nitric oxide for inhalation
Either 10 or 20 ppm of inhaled nitric oxide for 24 hour post transplant
Placebo
Placebo gas will be given at 10 or 20 ppm for 24 hours post transplant
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Mallinckrodt
INDUSTRY
Responsible Party
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Principal Investigators
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Neil MacIntyre, MD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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Duke University Medical Center
Durham, North Carolina, United States
Countries
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Other Identifiers
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MACIN1
Identifier Type: -
Identifier Source: org_study_id
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