The Impact of Obesity on Postoperative Outcomes Following Cardiac Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

610 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-11-30

Study Completion Date

2030-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Obesity Cardiac Disease Cardiovascular Syndromes, Metabolic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

cardiac surgery

Intervention Type PROCEDURE

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

cardiac surgery

Intervention Type PROCEDURE

cardiac surgery including non-emergency, elective coronary artery bypass grafting surgery with or without valve surgery, aortic or mitral valve surgery

Interventions

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cardiac surgery

cardiac surgery including non-emergency, elective coronary artery bypass grafting surgery with or without valve surgery, aortic or mitral valve surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No