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

This study has been terminated.
(Slow Enrollment)
Sponsor:
Information provided by:
INO Therapeutics
ClinicalTrials.gov Identifier:
NCT00060450
First received: May 6, 2003
Last updated: June 14, 2010
Last verified: June 2010
History of Changes

May 6, 2003
June 14, 2010
August 2001
September 2006   (final data collection date for primary outcome measure)
  • arterial and mixed venous blood gases [ Time Frame: first 4 hours post transplant ] [ Designated as safety issue: No ]
  • pulmonary vascular pressures [ Time Frame: first 4 hours post transplant ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00060450 on ClinicalTrials.gov Archive Site
  • cardiac output [ Time Frame: first 4 hours post transplant ] [ Designated as safety issue: No ]
  • systemic hemodynamics [ Time Frame: first 4 hours post transplant ] [ Designated as safety issue: No ]
  • NO2 and NO concentrations [ Time Frame: duration of treatment ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
Inhaled Nitric Oxide in Prevention/Treatment of Ischemia-Reperfusion Lung Injury Related to Lung Transplantation
Inhaled Nitric Oxide in Prevention/Treatment of Ischemia-Reperfusion Lung Injury Related to Lung Transplantation

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.

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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Ischemia-Reperfusion Injury
  • Drug: nitric oxide for inhalation
    Either 10 or 20 ppm of inhaled nitric oxide for 24 hour post transplant
    Other Name: INOmax®
  • Drug: Placebo
    Placebo gas will be given at 10 or 20 ppm for 24 hours post transplant
  • Experimental: 1
    Inhaled Nitric Oxide
    Intervention: Drug: nitric oxide for inhalation
  • Placebo Comparator: 2
    Placebo gas
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
84
September 2006
September 2006   (final data collection date for primary outcome measure)

Inclusion criteria:

  • Patients undergoing lung transplantation

Exclusion criteria:

  • Participation in other experimental protocols
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00060450
MACIN1
No
Robert Small, INO Therapeutics
INO Therapeutics
Not Provided
Principal Investigator: Neil MacIntyre, MD Duke University
INO Therapeutics
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP