Lung DysfunctionNCT00734266
Changes in Leukotrienes During Cardiac Surgery in Patients With Chronic Obstructive Pulmonary Disease
An observational study of Lung Dysfunction and Inflammatory Response During Cardiac Surgery, run by Massachusetts General Hospital.
Trial summary
The hypotheses of this study are that: Production and release of inflammatory substances called leukotrienes are increased during heart surgery with use of a heart-lung machine in humans; The increase in these leukotrienes levels after heart surgery is higher in patients with bronchitis and/or emphysema than in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Dysfunction, Inflammatory Response During Cardiac Surgery
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Apr 2007to Dec 2010
- Phase
- Observational
- 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
Study population: Adult patients schedules to undergo cardiac surgery with use of CPB.
Who may be able to join
- Adult patients schedules to undergo cardiac surgery with use of CPB.
Who cannot join
- inability to provide consent;
- previous diagnosis of asthma;
- acute pre-operative respiratory failure;
- emergency surgery.
About this study
The hypotheses of this study are that:
- Production and release of inflammatory substances called leukotrienes are increased during heart surgery with use of a heart-lung machine in humans;
- The increase in these leukotrienes levels after heart surgery is higher in patients with bronchitis and/or emphysema than in patients without previous history of lung disease;
- Levels of leukotrienes are directly correlated with worsening of lung function during and after heart surgery.
Read the detailed description
In this project, we will test the hypothesis that cys-leukotrienes are released and correlated with the impairment of the lung function after cardiac surgery in patients with COPD. If such hypothesis is substantiated in the study, it would allow us to propose the use of leukotriene inhibitors in the peri-operative period to improve pulmonary function and to decrease complications after cardiac surgery in COPD patients.
- Keywords
- COPD, CPB, Leukotrienes
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 Control | Patients with and without chronic obstructive pulmonary disease diagnosed before scheduling for cardiac surgery. | |
| 2 COPD | Patients with and without chronic obstructive pulmonary disease diagnosed before scheduling for cardiac surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
urine cysteinyl leukotriene
Measured: intra-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2008 (estimated)
- Study startApr 2007
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung DysfunctionStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Marcos Vidal Melo, Massachusetts General Hospital
- Investigators
- Marcos F Vidal Melo, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00734266
- Sponsor's protocol ID
- 2007-P-000164/7
- Status last verified
- Mar 2013
- First submitted
- 12 Aug 2008
- Last updated
- 6 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Leukotrienes During Cardiac Surgery in Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT00734266
- Acronym / sponsor ID
- 2007-P-000164/7
- Keywords
- COPD, CPB, Leukotrienes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Apr 2007
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 14 Aug 2008 (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 hypotheses of this study are that:
- Production and release of inflammatory substances called leukotrienes are increased during heart surgery with use of a heart-lung machine in humans;
- The increase in these leukotrienes levels after heart surgery is higher in patients with bronchitis and/or emphysema than in patients without previous history of lung disease;
- Levels of leukotrienes are directly correlated with worsening of lung function during and after heart surgery.
Detailed description
In this project, we will test the hypothesis that cys-leukotrienes are released and correlated with the impairment of the lung function after cardiac surgery in patients with COPD. If such hypothesis is substantiated in the study, it would allow us to propose the use of leukotriene inhibitors in the peri-operative period to improve pulmonary function and to decrease complications after cardiac surgery in COPD patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 Control | – | –Patients with and without chronic obstructive pulmonary disease diagnosed before scheduling for cardiac surgery. |
| 2 COPD | – | –Patients with and without chronic obstructive pulmonary disease diagnosed before scheduling for cardiac surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients schedules to undergo cardiac surgery with use of CPB.
Key inclusion criteria (1 listed)
- Adult patients schedules to undergo cardiac surgery with use of CPB.
Key exclusion criteria (4 listed)
- inability to provide consent;
- previous diagnosis of asthma;
- acute pre-operative respiratory failure;
- emergency surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
urine cysteinyl leukotriene
Time frame: intra-operative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2013.
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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.
Marcos F Vidal Melo, MD principal investigator
Massachusetts General Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Dysfunction and Inflammatory Response During Cardiac Surgery, run by Massachusetts General Hospital.
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 4 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: finished, as of the sponsor's last update on 6 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
urine cysteinyl leukotriene (time frame: intra-operative). 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 6 Mar 2013.