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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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

Further study details as provided by INO Therapeutics:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Patients undergoing lung transplantation

Exclusion criteria:

  • Participation in other experimental protocols
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00060450

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

No publications provided

Responsible Party: Robert Small, INO Therapeutics
ClinicalTrials.gov Identifier: NCT00060450     History of Changes
Other Study ID Numbers: MACIN1
Study First Received: May 6, 2003
Last Updated: June 14, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by INO Therapeutics:
Ischemia-reperfusion lung injury
IRLI

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

ClinicalTrials.gov processed this record on June 17, 2013