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

NCT00060450 | Terminated Phase 3

• 1 other identifier: MACIN1
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemia-Reperfusion Injury

Keywords

Ischemia-reperfusion lung injury; IRLI

Outcome Measures

Primary Outcomes (2)

• arterial and mixed venous blood gases

  first 4 hours post transplant

• pulmonary vascular pressures

  first 4 hours post transplant

Secondary Outcomes (3)

• cardiac output

  first 4 hours post transplant

• systemic hemodynamics

  first 4 hours post transplant

• NO2 and NO concentrations

  duration of treatment

Study Arms (2)

1

EXPERIMENTAL

Inhaled Nitric Oxide

Drug: nitric oxide for inhalation

2

PLACEBO COMPARATOR

Placebo gas

Drug: Placebo

Interventions

nitric oxide for inhalation DRUG

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

Also known as: INOmax®

1

Placebo DRUG

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

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing lung transplantation

You may not qualify if:

• Participation in other experimental protocols

Sponsors & Collaborators

• Mallinckrodt: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Reperfusion Injury

Interventions

Nitric Oxide; Inhalation; Endothelium-Dependent Relaxing Factors

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Reactive Nitrogen Species; Free Radicals; Inorganic Chemicals; Nitrogen Oxides; Nitrogen Compounds; Oxides; Oxygen Compounds; Organic Chemicals; Respiratory Mechanics; Respiration; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Vasodilator Agents; Cardiovascular Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Neil MacIntyre, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2003
• First Posted: May 7, 2003
• Study Start: August 1, 2001
• Primary Completion: September 1, 2006
• Study Completion: September 1, 2006
• Last Updated: September 9, 2016

Record last verified: 2016-09

Locations

US (1)