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

Primary Purpose

Ischemia-Reperfusion Injury

Status

Terminated

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

nitric oxide for inhalation

Placebo

About this trial

This is an interventional prevention trial for Ischemia-Reperfusion Injury focused on measuring Ischemia-reperfusion lung injury, IRLI

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria: Patients undergoing lung transplantation Exclusion criteria: Participation in other experimental protocols

Sites / Locations

Duke University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

Inhaled Nitric Oxide

Placebo gas

Outcomes

Primary Outcome Measures

arterial and mixed venous blood gases

pulmonary vascular pressures

Secondary Outcome Measures

cardiac output

systemic hemodynamics

NO2 and NO concentrations

Full Information

NCT ID

NCT00060450

First Posted

May 6, 2003

Last Updated

September 8, 2016

Sponsor

Mallinckrodt

1. Study Identification

Unique Protocol Identification Number

NCT00060450

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Terminated

Why Stopped

Slow Enrollment

Study Start Date

August 2001 (undefined)

Primary Completion Date

September 2006 (Actual)

Study Completion Date

September 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mallinckrodt

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ischemia-Reperfusion Injury

Keywords

Ischemia-reperfusion lung injury, IRLI

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

84 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Inhaled Nitric Oxide

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo gas

Intervention Type

Drug

Intervention Name(s)

nitric oxide for inhalation

Other Intervention Name(s)

INOmax®

Intervention Description

Either 10 or 20 ppm of inhaled nitric oxide for 24 hour post transplant

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo gas will be given at 10 or 20 ppm for 24 hours post transplant

Primary Outcome Measure Information:

Title

arterial and mixed venous blood gases

Time Frame

first 4 hours post transplant

Title

pulmonary vascular pressures

Time Frame

first 4 hours post transplant

Secondary Outcome Measure Information:

Title

cardiac output

Time Frame

first 4 hours post transplant

Title

systemic hemodynamics

Time Frame

first 4 hours post transplant

Title

NO2 and NO concentrations

Time Frame

duration of treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: Patients undergoing lung transplantation Exclusion criteria: Participation in other experimental protocols

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Neil MacIntyre, MD

Organizational Affiliation

Duke University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Duke University Medical Center

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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