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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:
ClinicalTrials.gov Identifier:
NCT00060450
First Posted: May 7, 2003
Last Update Posted: September 9, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mallinckrodt
  Purpose
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.

Condition Intervention Phase
Ischemia-Reperfusion Injury Drug: nitric oxide for inhalation Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Inhaled Nitric Oxide in Prevention/Treatment of Ischemia-Reperfusion Lung Injury Related to Lung Transplantation

Resource links provided by NLM:


Further study details as provided by Mallinckrodt:

Primary Outcome Measures:
  • arterial and mixed venous blood gases [ Time Frame: first 4 hours post transplant ]
  • pulmonary vascular pressures [ Time Frame: first 4 hours post transplant ]

Secondary Outcome Measures:
  • cardiac output [ Time Frame: first 4 hours post transplant ]
  • systemic hemodynamics [ Time Frame: first 4 hours post transplant ]
  • NO2 and NO concentrations [ Time Frame: duration of treatment ]

Enrollment: 84
Study Start Date: August 2001
Study Completion Date: September 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Inhaled Nitric Oxide
Drug: nitric oxide for inhalation
Either 10 or 20 ppm of inhaled nitric oxide for 24 hour post transplant
Other Name: INOmax®
Placebo Comparator: 2
Placebo gas
Drug: Placebo
Placebo gas will be given at 10 or 20 ppm for 24 hours post transplant

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Patients undergoing lung transplantation

Exclusion criteria:

  • Participation in other experimental protocols
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00060450


Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Mallinckrodt
Investigators
Principal Investigator: Neil MacIntyre, MD Duke University
  More Information

Responsible Party: Mallinckrodt
ClinicalTrials.gov Identifier: NCT00060450     History of Changes
Other Study ID Numbers: MACIN1
First Submitted: May 6, 2003
First Posted: May 7, 2003
Last Update Posted: September 9, 2016
Last Verified: September 2016

Keywords provided by Mallinckrodt:
Ischemia-reperfusion lung injury
IRLI

Additional relevant MeSH terms:
Wounds and Injuries
Ischemia
Lung Injury
Reperfusion Injury
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Thoracic Injuries
Vascular Diseases
Cardiovascular Diseases
Postoperative Complications
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Gasotransmitters
Protective Agents