The Impact of Obesity on Postoperative Outcomes Following Cardiac Surgery
- Conditions
- Cardiac DiseaseObesityCardiovascular Syndromes, Metabolic
- Interventions
- Procedure: cardiac surgery
- Registration Number
- NCT03248921
- Lead Sponsor
- Cardiovascular Research New Brunswick
- 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.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 610
-
· Provide informed consent
- Male or female patients who are > 18 years of age
- Patients must be scheduled to undergo elective, first-time cardiac surgery during routine scheduling times
- Patients who are > 75 years of age
- BMI is less than 18.5 kg/m2 and classified as underweight according to the World Health Organization
- Any non-elective first time cardiac surgery patient (eg. in-house urgent patients; emergent patients)
- Any cardiac patients to undergo re-operation
- Simultaneous participation in another study with an investigational study agent
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description High-Fit obese cardiac surgery Cardiac surgery patients will be segregated into the high-fit group based on 6 minute walk test distance and other measures of functional capacity Low-Fit obese cardiac surgery Cardiac surgery patients will be segregated into the low-fit group based on 6 minute walk test distance and other measures of functional capacity
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Respiratory complications post-operative day (POD) 30 Pleural effusion, pneumonia
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
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
Prolonged ICU length of stay post-operative day (POD) 30 length of stay of more than 48 hours
Trial Locations
- Locations (1)
Saint John Regional Hospital
🇨🇦Saint John, New Brunswick, Canada