The purpose of this study is to identify measures of obesity, functional capacity, and specific biomarkers that may be predictive of obesity and post-operative outcomes.
Background: Increasing levels of obesity worldwide have led to a rise in the prevalence of obesity-related complications including cardiovascular disease, diabetes, cancers etc. Health care providers believe that obesity has a negative effect on patients undergoing cardiac surgery, with overweight and obese patients being more likely to experience adverse post-operative outcomes. The body mass index (BMI) is the single most used measure for determining obesity classification in clinical practice, without accounting for a patient's level of cardiopulmonary fitness or muscle mass. Study Design: Patients between the ages of 18 and 75 years undergoing elective cardiac surgery will be consented to participate in this prospective observational trial. Patients are invited to participate in measures of obesity, functional capacity and exercise capacity assessments, quality of life questionnaires, and blood and tissue sampling for biomarker analysis. Endpoints: Measures other than BMI that could be predictive of short-term and long-term post-operative outcomes. Outcomes of interest include: prolonged length of ventilation, hospital length of stay and all-cause mortality. Summary: The results of this trial will potentially identify an improved definition of fitness capacity for obese cardiac surgical patients and biomarkers alone or in combination that could identify the potential for adverse outcomes in patients undergoing cardiac surgery. This study will help clinicians better segregate and treat patients pre-operatively based on fitness levels and associated biomarkers.
Study Type
OBSERVATIONAL
Enrollment
610
cardiac surgery including non-emergency, elective coronary artery bypass grafting surgery with or without valve surgery, aortic or mitral valve surgery
Saint John Regional Hospital
Saint John, New Brunswick, Canada
Prolonged Hospitalization
A length of stay of more than 5 days
Time frame: post-operative day (POD) 30
Prolonged ventilation > 24 hours
mechanical ventilation for more than 24 hours of invasive (via endotracheal tube or tracheostomy) and/or noninvasive (facial/nasal interface) methods of delivery
Time frame: post-operative day (POD) 30
all cause mortality
Patient death, either in hospital or long-term
Time frame: post-operative day (POD) 30 and 1 year post-op
non fatal myocardial infarction
Transmural, Subendocardial infarction
Time frame: post-operative day (POD) 30 and 1 year post-op
Stroke
Transient, permanent
Time frame: post-operative day (POD) 30
Respiratory complications
Pleural effusion, pneumonia
Time frame: post-operative day (POD) 30
Prolonged ICU length of stay
length of stay of more than 48 hours
Time frame: post-operative day (POD) 30
Re-operation for any cause
re-operation due to complications, bleeding and/or other reasons
Time frame: post-operative day (POD) 30 and 1 year post-op
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Atrial fibrillation
post-op occurrence requiring treatment
Time frame: post-operative day (POD) 30 and 1 year post-op
Post-operative length of stay and disposition on discharge
home, home with care, transfer to other facility, or expired
Time frame: post-operative day (POD) 30 and 1 year post-op
Wound infection
infection of sternum or other incisional access sites
Time frame: post-operative day (POD) 30