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

Inflammatory Response During Cardiac Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00734266
• Other study ID #: 2007-P-000164/7
• Status: Completed
• Phase: N/A
• First received: August 12, 2008
• Last updated: March 5, 2013
• Start date: April 2007
• Est. completion date: December 2010

Study information

• Verified date: March 2013
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Inflammatory Response During Cardiac Surgery
• Lung Diseases
• Lung Diseases, Obstructive
• Lung Dysfunction
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	urine cysteinyl leukotriene		intra-operative	No