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Active, Not Recruiting

NCT Number: NCT03248921

The Impact of Obesity on Postoperative Outcomes Following Cardiac Surgery

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Obesity Body Weight Cardiac Disease Cardiovascular Diseases Cardiovascular Syndromes, Metabolic Glucose Metabolism Disorders Heart Diseases Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Saint John Regional Hospital

Saint John, New Brunswick, E2L 4L2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cardiac surgery

Procedure

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Cardiovascular Research New Brunswick

Other

Collaborators

  • Horizon Health Network
  • Maritime Heart Centre

Registry information

Acronym: OPOS

Important dates

Study start
2014
Primary completion
2025
Study completion
2030
First posted
Aug 15, 2017
Registry last updated
Jul 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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