Changes in Leukotrienes During Cardiac Surgery in Patients With Chronic Obstructive Pulmonary Disease
This study has been completed.
Sponsor:
Massachusetts General Hospital
Collaborator:
Merck
Information provided by (Responsible Party):
Marcos Vidal Melo, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00734266
First received: August 12, 2008
Last updated: March 5, 2013
Last verified: March 2013
| Tracking Information | |||||
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| First Received Date ICMJE | August 12, 2008 | ||||
| Last Updated Date | March 5, 2013 | ||||
| Start Date ICMJE | April 2007 | ||||
| Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
urine cysteinyl leukotriene [ Time Frame: intra-operative ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00734266 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Changes in Leukotrienes During Cardiac Surgery in Patients With Chronic Obstructive Pulmonary Disease | ||||
| Official Title ICMJE | Changes in Leukotrienes During Cardiac Surgery in Patients With Chronic Obstructive Pulmonary Disease | ||||
| Brief Summary | The hypotheses of this study are that:
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Adult patients schedules to undergo cardiac surgery with use of CPB. |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 20 | ||||
| Completion Date | December 2010 | ||||
| Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00734266 | ||||
| Other Study ID Numbers ICMJE | 2007-P-000164/7 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Marcos Vidal Melo, Massachusetts General Hospital | ||||
| Study Sponsor ICMJE | Massachusetts General Hospital | ||||
| Collaborators ICMJE | Merck | ||||
| Investigators ICMJE |
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| Information Provided By | Massachusetts General Hospital | ||||
| Verification Date | March 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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