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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00060450

Enrollment

Registered

2003-05-07

Start date

2001-08-31

Completion date

2006-09-30

Last updated

2016-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemia-Reperfusion Injury

Keywords

Ischemia-reperfusion lung injury, IRLI

Brief summary

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

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.

Interventions

DRUGnitric oxide for inhalation

Either 10 or 20 ppm of inhaled nitric oxide for 24 hour post transplant

DRUGPlacebo

Placebo gas will be given at 10 or 20 ppm for 24 hours post transplant

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients undergoing lung transplantation

Exclusion criteria

* Participation in other experimental protocols

Design outcomes

Primary

Measure	Time frame
arterial and mixed venous blood gases	first 4 hours post transplant
pulmonary vascular pressures	first 4 hours post transplant

Secondary

Measure	Time frame
cardiac output	first 4 hours post transplant
systemic hemodynamics	first 4 hours post transplant
NO2 and NO concentrations	duration of treatment

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026