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
  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 Massachusetts General Hospital:

Primary Outcome Measures:
  • urine cysteinyl leukotriene [ Time Frame: intra-operative ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00734266

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

No publications provided

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
Study First Received: August 12, 2008
Last Updated: March 5, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
COPD
CPB
Leukotrienes

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

ClinicalTrials.gov processed this record on October 02, 2014