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

July 27, 2021 updated by: Ansar Hassan, MD, PhD, Cardiovascular Research New Brunswick
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

610

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • New Brunswick
      • Saint John, New Brunswick, Canada, E2L 4L2
        • Saint John Regional Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients scheduled to undergo elective, first-time cardiac surgery will be considered for eligibility to participate in the study. As well, a patient whose BMI is less than 18.5 kg/m2 and classified as underweight by the World Health Organization will be excluded. Only those patients who are classified as being normal weight range or overweight and/or obese may be considered for eligibility to participate as defined by the study objectives regarding post-operative cardiac surgery outcomes in obese patients. Patients in the normal weight range classification will be included as a baseline control participant cohort. Finally, patients over the age of 75 will be excluded so as to eliminate the role that advanced age may play in affecting functional capacity.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prolonged Hospitalization
Time Frame: post-operative day (POD) 30
A length of stay of more than 5 days
post-operative day (POD) 30
Prolonged ventilation > 24 hours
Time Frame: 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
post-operative day (POD) 30

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
all cause mortality
Time Frame: post-operative day (POD) 30 and 1 year post-op
Patient death, either in hospital or long-term
post-operative day (POD) 30 and 1 year post-op
non fatal myocardial infarction
Time Frame: post-operative day (POD) 30 and 1 year post-op
Transmural, Subendocardial infarction
post-operative day (POD) 30 and 1 year post-op
Stroke
Time Frame: post-operative day (POD) 30
Transient, permanent
post-operative day (POD) 30
Respiratory complications
Time Frame: post-operative day (POD) 30
Pleural effusion, pneumonia
post-operative day (POD) 30
Prolonged ICU length of stay
Time Frame: post-operative day (POD) 30
length of stay of more than 48 hours
post-operative day (POD) 30
Re-operation for any cause
Time Frame: post-operative day (POD) 30 and 1 year post-op
re-operation due to complications, bleeding and/or other reasons
post-operative day (POD) 30 and 1 year post-op
Atrial fibrillation
Time Frame: post-operative day (POD) 30 and 1 year post-op
post-op occurrence requiring treatment
post-operative day (POD) 30 and 1 year post-op
Post-operative length of stay and disposition on discharge
Time Frame: post-operative day (POD) 30 and 1 year post-op
home, home with care, transfer to other facility, or expired
post-operative day (POD) 30 and 1 year post-op
Wound infection
Time Frame: post-operative day (POD) 30
infection of sternum or other incisional access sites
post-operative day (POD) 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cardiovascular Research New Brunswick

Collaborators

Horizon Health Network
Maritime Heart Centre

Investigators

  • Principal Investigator: Ansar Hassan, MD, PhD, New Brunswick Heart Centre, Department of Cardiac Surgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2014

Primary Completion (Anticipated)

November 1, 2025

Study Completion (Anticipated)

November 1, 2030

Study Registration Dates

First Submitted

August 10, 2017

First Submitted That Met QC Criteria

August 10, 2017

First Posted (Actual)

August 15, 2017

Study Record Updates

Last Update Posted (Actual)

July 28, 2021

Last Update Submitted That Met QC Criteria

July 27, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RS#: 2014-2006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obesity

Clinical Trials on cardiac surgery

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Lithuania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe