Inflammatory Biomarkers Predict Pulmonary Outcomes in Coronary Artery Bypass Grafting

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Chronic Disease Chronic Obstructive Pulmonary Disease Coronary Disease Disease Attributes Heart Diseases Lung Diseases Lung Diseases, Obstructive Myocardial Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Vascular Diseases

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

Primary outcome measure

Time frame: 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 outcomes

Secondary outcome measure

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Registry information

Acronym: CABG BALF

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2013
First posted: Jun 6, 2011
Registry last updated: Feb 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed