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

Sponsored by:	INO Therapeutics
Information provided by:	INO Therapeutics
ClinicalTrials.gov Identifier:	NCT00060450

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 III

MedlinePlus related topics: Gas Lung Transplantation

Drug Information available for: Nitric oxide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Inhaled Nitric Oxide in Prevention/Treatment of Ischemia-Reperfusion Lung Injury Related to Lung Transplantation

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
1: Experimental Inhaled Nitric Oxide	Drug: nitric oxide for inhalation Either 10 or 20 ppm of inhaled nitric oxide for 24 hour post transplant
2: Placebo Comparator 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:	INO Therapeutics ( Robert Small )
Study ID Numbers:	MACIN1
Study First Received:	May 6, 2003
Last Updated:	January 9, 2009
ClinicalTrials.gov Identifier:	NCT00060450 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by INO Therapeutics:

Ischemia-reperfusion lung injury
IRLI

Study placed in the following topic categories:

Nitric Oxide
Vasodilator Agents
Neurotransmitter Agents
Antioxidants
Postoperative Complications
Vascular Diseases

Anti-Asthmatic Agents
Cardiovascular Agents
Peripheral Nervous System Agents
Ischemia
Bronchodilator Agents
Reperfusion Injury

Additional relevant MeSH terms:

Respiratory System Agents
Vasodilator Agents
Neurotransmitter Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Vascular Diseases
Anti-Asthmatic Agents
Cardiovascular Agents
Ischemia
Protective Agents
Pharmacologic Actions

Nitric Oxide
Pathologic Processes
Postoperative Complications
Autonomic Agents
Therapeutic Uses
Free Radical Scavengers
Endothelium-Dependent Relaxing Factors
Cardiovascular Diseases
Peripheral Nervous System Agents
Bronchodilator Agents
Reperfusion Injury

ClinicalTrials.gov processed this record on May 06, 2009