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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00734266
First Posted: August 14, 2008
Last Update Posted: March 6, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Marcos Vidal Melo, Massachusetts General Hospital
  Purpose

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.

Condition
Lung Dysfunction Inflammatory Response During Cardiac Surgery

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Changes in Leukotrienes During Cardiac Surgery in Patients With Chronic Obstructive Pulmonary Disease

Resource links provided by NLM:


Further study details as provided by Marcos Vidal Melo, Massachusetts General Hospital:

Primary Outcome Measures:
  • urine cysteinyl leukotriene [ Time Frame: intra-operative ]

Enrollment: 20
Study Start Date: April 2007
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients schedules to undergo cardiac surgery with use of CPB.
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00734266


Sponsors and Collaborators
Massachusetts General Hospital
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Marcos F Vidal Melo, MD Massachusetts General Hospital
  More Information

Responsible Party: Marcos Vidal Melo, Associate Professor of Anesthesia, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00734266     History of Changes
Other Study ID Numbers: 2007-P-000164/7
First Submitted: August 12, 2008
First Posted: August 14, 2008
Last Update Posted: March 6, 2013
Last Verified: March 2013

Keywords provided by Marcos Vidal Melo, Massachusetts General Hospital:
COPD
CPB
Leukotrienes

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases