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Changes in Leukotrienes During Cardiac Surgery in Patients With Chronic Obstructive Pulmonary Disease

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
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

August 12, 2008
March 5, 2013
April 2007
December 2010   (final data collection date for primary outcome measure)
urine cysteinyl leukotriene [ Time Frame: intra-operative ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00734266 on ClinicalTrials.gov Archive Site
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Changes in Leukotrienes During Cardiac Surgery in Patients With Chronic Obstructive Pulmonary Disease
Changes in Leukotrienes During Cardiac Surgery in Patients With Chronic Obstructive Pulmonary Disease

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample

Adult patients schedules to undergo cardiac surgery with use of CPB.

  • Lung Dysfunction
  • Inflammatory Response During Cardiac Surgery
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  • 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.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
December 2010
December 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients schedules to undergo cardiac surgery with use of CPB.

Exclusion Criteria:

  • inability to provide consent;
  • previous diagnosis of asthma;
  • acute pre-operative respiratory failure;
  • emergency surgery.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00734266
2007-P-000164/7
Yes
Marcos Vidal Melo, Massachusetts General Hospital
Massachusetts General Hospital
Merck Sharp & Dohme Corp.
Principal Investigator: Marcos F Vidal Melo, MD Massachusetts General Hospital
Massachusetts General Hospital
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP