Ischemia-Reperfusion InjuryPhase 3NCT00060450
Inhaled Nitric Oxide in Prevention/Treatment of Ischemia-Reperfusion Lung Injury Related to Lung Transplantation
A Phase 3 study testing nitric oxide for inhalation in people with Ischemia-Reperfusion Injury, run by Mallinckrodt at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemia-Reperfusion Injury
- What is being tested?
- nitric oxide for inhalation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2001to Sep 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing lung transplantation
Who cannot join
- Participation in other experimental protocols
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
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.
Read the 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.
- Conditions
- Ischemia-Reperfusion Injury
- Being tested
- nitric oxide for inhalation, Placebo
- Keywords
- Ischemia-reperfusion lung injury, IRLI
- Medical subject headings
- Reperfusion Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nitric oxide for inhalationDrug
Also called INOmax®
Either 10 or 20 ppm of inhaled nitric oxide for 24 hour post transplant
PlaceboDrug
Placebo gas will be given at 10 or 20 ppm for 24 hours post transplant
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Inhaled Nitric Oxide Receives: Drug: nitric oxide for inhalation |
| 2 | Placebo comparator | Placebo gas Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
arterial and mixed venous blood gases
Measured: first 4 hours post transplant
pulmonary vascular pressures
Measured: first 4 hours post transplant
Secondary outcomes (3)
cardiac output
Measured: first 4 hours post transplant
systemic hemodynamics
Measured: first 4 hours post transplant
NO2 and NO concentrations
Measured: duration of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2003 (estimated)
- Study startAug 2001
- Primary completionSep 2006
- Study completionSep 2006
Why it stopped: Slow Enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemia-Reperfusion InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mallinckrodt
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Neil MacIntyre, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00060450
- Sponsor's protocol ID
- MACIN1
- Status last verified
- Sep 2016
- First submitted
- 6 May 2003
- Last updated
- 9 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inhaled Nitric Oxide in Prevention/Treatment of Ischemia-Reperfusion Lung Injury Related to Lung Transplantation
- ClinicalTrials.gov ID
- NCT00060450
- Acronym / sponsor ID
- MACIN1
- Conditions
- Ischemia-Reperfusion Injury
- Keywords
- Ischemia-reperfusion lung injury, IRLI
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow Enrollment
- Enrolment
- 84 participants (actual)
- Lead sponsor
- MallinckrodtIndustry (pharma, biotech, devices)
- Study start
- Aug 2001
- Primary completion
- Sep 2006 (actual)
- Study completion
- Sep 2006 (actual)
- First posted
- 7 May 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: nitric oxide for inhalationInhaled Nitric Oxide |
| 2 | Placebo comparator | Drug: PlaceboPlacebo gas |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing lung transplantation
Key exclusion criteria (1 listed)
- Participation in other experimental protocols
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nitric oxide for inhalationAlso: INOmax®Either 10 or 20 ppm of inhaled nitric oxide for 24 hour post transplant | Drug | 1 |
| PlaceboPlacebo gas will be given at 10 or 20 ppm for 24 hours post transplant | Drug | 2 |
Primary outcome
arterial and mixed venous blood gases
Time frame: first 4 hours post transplant
pulmonary vascular pressures
Time frame: first 4 hours post transplant
3 secondary outcomes
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
Results and safety
The study was stopped early (reason given: Slow Enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neil MacIntyre, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing nitric oxide for inhalation in people with Ischemia-Reperfusion Injury, run by Mallinckrodt at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Slow Enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
arterial and mixed venous blood gases (time frame: first 4 hours post transplant). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2016.