OPOS: The Impact of Obesity on Postoperative Outcomes Following Cardiac Surgery
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| High-Fit obese Cardiac surgery patients will be segregated into the high-fit group based on 6 minute walk test distance and other measures of functional capacity |
Procedure: cardiac surgery
cardiac surgery including non-emergency, elective coronary artery bypass grafting surgery with or without valve surgery, aortic or mitral valve surgery
|
| Low-Fit obese Cardiac surgery patients will be segregated into the low-fit group based on 6 minute walk test distance and other measures of functional capacity |
Procedure: cardiac surgery
cardiac surgery including non-emergency, elective coronary artery bypass grafting surgery with or without valve surgery, aortic or mitral valve surgery
|
Outcome Measures
Primary Outcome Measures
- Prolonged Hospitalization [post-operative day (POD) 30]
A length of stay of more than 5 days
- Prolonged ventilation > 24 hours [post-operative day (POD) 30]
mechanical ventilation for more than 24 hours of invasive (via endotracheal tube or tracheostomy) and/or noninvasive (facial/nasal interface) methods of delivery
Secondary Outcome Measures
- all cause mortality [post-operative day (POD) 30 and 1 year post-op]
Patient death, either in hospital or long-term
- non fatal myocardial infarction [post-operative day (POD) 30 and 1 year post-op]
Transmural, Subendocardial infarction
- Stroke [post-operative day (POD) 30]
Transient, permanent
- Respiratory complications [post-operative day (POD) 30]
Pleural effusion, pneumonia
- Prolonged ICU length of stay [post-operative day (POD) 30]
length of stay of more than 48 hours
- Re-operation for any cause [post-operative day (POD) 30 and 1 year post-op]
re-operation due to complications, bleeding and/or other reasons
- Atrial fibrillation [post-operative day (POD) 30 and 1 year post-op]
post-op occurrence requiring treatment
- Post-operative length of stay and disposition on discharge [post-operative day (POD) 30 and 1 year post-op]
home, home with care, transfer to other facility, or expired
- Wound infection [post-operative day (POD) 30]
infection of sternum or other incisional access sites
Eligibility Criteria
Criteria
Inclusion Criteria:
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· Provide informed consent
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Male or female patients who are > 18 years of age
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Patients must be scheduled to undergo elective, first-time cardiac surgery during routine scheduling times
Exclusion Criteria:
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Patients who are > 75 years of age
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BMI is less than 18.5 kg/m2 and classified as underweight according to the World Health Organization
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Any non-elective first time cardiac surgery patient (eg. in-house urgent patients; emergent patients)
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Any cardiac patients to undergo re-operation
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Simultaneous participation in another study with an investigational study agent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Saint John Regional Hospital | Saint John | New Brunswick | Canada | E2L 4L2 |
Sponsors and Collaborators
- Cardiovascular Research New Brunswick
- Horizon Health Network
- Maritime Heart Centre
Investigators
- Principal Investigator: Ansar Hassan, MD, PhD, New Brunswick Heart Centre, Department of Cardiac Surgery
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- RS#: 2014-2006