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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03248921
Recruitment Status : Active, not recruiting
First Posted : August 15, 2017
Last Update Posted : July 28, 2021
Sponsor:
Collaborators:
Horizon Health Network
Maritime Heart Centre
Information provided by (Responsible Party):
Ansar Hassan, MD, PhD, Dalhousie University

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Obesity Cardiac Disease Cardiovascular Syndromes, Metabolic Procedure: cardiac surgery

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
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Study Type : Observational
Estimated Enrollment : 610 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Impact of Obesity on Postoperative Outcomes Following Cardiac Surgery
Actual Study Start Date : November 2014
Estimated Primary Completion Date : November 2025
Estimated Study Completion Date : November 2030

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. Prolonged Hospitalization [ Time Frame: post-operative day (POD) 30 ]
    A length of stay of more than 5 days

  2. 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


Secondary Outcome Measures :
  1. all cause mortality [ Time Frame: post-operative day (POD) 30 and 1 year post-op ]
    Patient death, either in hospital or long-term

  2. non fatal myocardial infarction [ Time Frame: post-operative day (POD) 30 and 1 year post-op ]
    Transmural, Subendocardial infarction

  3. Stroke [ Time Frame: post-operative day (POD) 30 ]
    Transient, permanent

  4. Respiratory complications [ Time Frame: post-operative day (POD) 30 ]
    Pleural effusion, pneumonia

  5. Prolonged ICU length of stay [ Time Frame: post-operative day (POD) 30 ]
    length of stay of more than 48 hours

  6. 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

  7. Atrial fibrillation [ Time Frame: post-operative day (POD) 30 and 1 year post-op ]
    post-op occurrence requiring treatment

  8. 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

  9. Wound infection [ Time Frame: post-operative day (POD) 30 ]
    infection of sternum or other incisional access sites


Biospecimen Retention:   Samples With DNA
The following biological samples have been approved for collection: 4 types of adipose tissue (subcutaneous adipose tissue; epicardial adipose tissue; pericardial adipose tissue; peri-aortic adipose tissue); atrial appendage tissue sample; and 8-10mL blood sample (plasma and serum sample).

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03248921


Locations
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Canada, New Brunswick
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
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Principal Investigator: Ansar Hassan, MD, PhD New Brunswick Heart Centre, Department of Cardiac Surgery
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ansar Hassan, MD, PhD, Principal Investigator, Dalhousie University
ClinicalTrials.gov Identifier: NCT03248921    
Other Study ID Numbers: RS#: 2014-2006
First Posted: August 15, 2017    Key Record Dates
Last Update Posted: July 28, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Heart Diseases
Obesity
Metabolic Syndrome
Overweight
Overnutrition
Nutrition Disorders
 Body Weight
Cardiovascular Diseases
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases