Inflammatory Biomarkers Predict Pulmonary Outcomes in Coronary Artery Bypass Grafting

Completed

• Conditions: Chronic Obstructive Pulmonary Disease; Coronary Artery Disease

• Registration Number: NCT01366469
• Lead Sponsor: Emory University

Brief Summary

The primary objective of this pilot study is to identify and quantify inflammatory and genetic markers from bronchoalveolar lavage fluid (BALF) and serum in patients with a history of chronic obstructive pulmonary disease (COPD) undergoing elective coronary revascularization (CABG) to determine the risk of developing post operative respiratory failure. To achieve this objective, this proposal outlines the following specific aims:

Aim #1. To identify from BALF and serum, the change in inflammatory and genetic markers in patients with a history of COPD undergoing CABG. BALF and serum samples will be obtained at the time of intubation immediately prior to surgery and again upon skin closure immediately after the surgical procedure.

Aim #2. To determine the extent to which inflammatory and/or genetic markers correlate with post-operative pulmonary complications defined as prolonged mechanical ventilation (\> 24 hours), pneumonia, and/or tracheostomy.

Aim #3. To inform the development and implementation of a large pivotal trial which may impact clinical decision-making during the initial pre-operative outpatient assessment of COPD patients undergoing CABG.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-06-02
• Study First Submitted QC: 2011-06-03
• Study First Posted: 2011-06-06
• Primary Completion: 2012-12
• Study Completion: 2013-12
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-18
• Last Update Posted: 2014-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Undergoing elective CABG
• Current diagnosis of COPD
• Ability to provide signed informed consent to participate
• > 18 years of age

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Exclusion Criteria

• Concomitant valve surgery
• Urgent or emergent coronary surgery
• Current steroid therapy
• Active smoker and/or positive urine co-nicotine

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome measure	During Hospitalization	The identification of specific inflammatory and genetic markers associated with post-operative pulmonary complications in this population of elective CABG patients with a history of COPD.

Secondary Outcome Measures

Name	Time	Method
Secondary outcome measure	30 Day Follow-up	Post-operative pulmonary complications: prolonged mechanical ventilation (defined as \>24 hours), atelectasis, pneumonia, exacerbation of COPD and tracheostomy. All-cause mortality will also be assessed.

Trial Locations

Locations (1)

Emory University Hospital Midtown; 🇺🇸 Atlanta, Georgia, United States