The Impact of Obesity on Postoperative Outcomes Following Cardiac Surgery (OPOS)

Cardiovascular Research New Brunswick

Status

Active, not recruiting

Conditions

Cardiovascular Syndromes, Metabolic

Cardiac Disease

Obesity

Treatments

Procedure: cardiac surgery

Study type

Observational

Funder types

Other

Identifiers

NCT03248921

RS#: 2014-2006

Details and patient eligibility

About

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.

Full 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.

Enrollment

610 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

· 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

Exclusion criteria

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