Inflammatory Biomarkers Predict Pulmonary Outcomes in Coronary Artery Bypass Grafting

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01366469

Acronym

CABG BALF

Enrollment

Registered

2011-06-06

Start date

2011-04-30

Completion date

2013-12-31

Last updated

2014-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease, Coronary Artery Disease

Keywords

coronary artery bypass grafting, coronary artery disease, chronic obstructive pulmonary disease

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 89 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Outcome results