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

NCT ID: NCT00734266

Last Updated: 2013-03-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-04-30
• Study Completion Date: 2010-12-31

Brief 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 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.

Conditions

Lung Dysfunction; Inflammatory Response During Cardiac Surgery

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

1 Control

Patients with and without chronic obstructive pulmonary disease diagnosed before scheduling for cardiac surgery.

No interventions assigned to this group

2 COPD

Patients with and without chronic obstructive pulmonary disease diagnosed before scheduling for cardiac surgery.

No interventions assigned to this group

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Marcos Vidal Melo

Associate Professor of Anesthesia

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marcos F Vidal Melo, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Other Identifiers

2007-P-000164/7

Identifier Type: -

Identifier Source: org_study_id