Inflammatory Biomarkers Predict Pulmonary Outcomes in Coronary Artery Bypass Grafting (CABG BALF)
|ClinicalTrials.gov Identifier: NCT01366469|
Recruitment Status : Completed
First Posted : June 6, 2011
Last Update Posted : February 19, 2014
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.
|Condition or disease|
|Coronary Artery Disease Chronic Obstructive Pulmonary Disease|
|Study Type :||Observational|
|Actual Enrollment :||10 participants|
|Official Title:||Inflammatory Biomarkers Predict Pulmonary Outcomes in Coronary Artery Bypass Grafting|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||December 2013|
- 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 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.
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01366469
|United States, Georgia|
|Emory University Hospital Midtown|
|Atlanta, Georgia, United States, 30308|
|Principal Investigator:||Omar M Lattouf, MD||Emory University|