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

Phase 3

Terminated

• Conditions: Ischemia-Reperfusion Injury
• Interventions: Drug: nitric oxide for inhalation; Drug: Placebo

• Registration Number: NCT00060450
• Lead Sponsor: Mallinckrodt

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.

Study Timeline

• Study Start: 2001-08
• Study First Submitted: 2003-05-06
• Study First Submitted QC: 2003-05-06
• Study First Posted: 2003-05-07
• Primary Completion: 2006-09
• Study Completion: 2006-09
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-08
• Last Update Posted: 2016-09-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	nitric oxide for inhalation	Inhaled Nitric Oxide
2	Placebo	Placebo gas

Primary Outcome Measures

Name	Time	Method
arterial and mixed venous blood gases	first 4 hours post transplant
pulmonary vascular pressures	first 4 hours post transplant

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States