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

Ischemia-Reperfusion Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00060450
• Other study ID #: MACIN1
• Status: Terminated
• Phase: Phase 3
• First received: May 6, 2003
• Last updated: September 8, 2016
• Start date: August 2001
• Est. completion date: September 2006

Study information

• Verified date: September 2016
• Source: Mallinckrodt
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 84
• Est. completion date: September 2006
• Est. primary completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Patients undergoing lung transplantation

Exclusion criteria:

• Participation in other experimental protocols

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Ischemia
• Ischemia-Reperfusion Injury
• Lung Injury
• Reperfusion Injury
• Wounds and Injuries

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Mallinckrodt

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	arterial and mixed venous blood gases		first 4 hours post transplant	No
Primary	pulmonary vascular pressures		first 4 hours post transplant	No
Secondary	cardiac output		first 4 hours post transplant	No
Secondary	systemic hemodynamics		first 4 hours post transplant	No
Secondary	NO2 and NO concentrations		duration of treatment	Yes