The Impact of Obesity on Postoperative Outcomes Following Cardiac Surgery

Obesity Clinical Trial

— OPOS  

Official title:

The Impact of Obesity on Postoperative Outcomes Following Cardiac Surgery

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03248921
• Other study ID #: RS#: 2014-2006
• Status: Active, not recruiting
• Start date: November 2014
• Est. completion date: November 2030

Study information

• Verified date: July 2021
• Source: Cardiovascular Research New Brunswick
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 610
• Est. completion date: November 2030
• Est. primary completion date: November 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Disease
• Cardiovascular Syndromes, Metabolic
• Heart Diseases
• Metabolic Syndrome
• Obesity

Intervention

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

Locations

Country	Name	City	State
Canada	Saint John Regional Hospital	Saint John	New Brunswick

Sponsors (3)

Lead Sponsor	Collaborator
Cardiovascular Research New Brunswick	Horizon Health Network, Maritime Heart Centre

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Aguiar C, MacLeod J, Yip A, Melville S, Légaré JF, Pulinilkunnil T, Kienesberger P, Brunt K, Hassan A. Impact of Obesity on Postoperative Outcomes following cardiac Surgery (The OPOS study): rationale and design of an investigator-initiated prospective study. BMJ Open. 2019 Mar 3;9(3):e023418. doi: 10.1136/bmjopen-2018-023418. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prolonged Hospitalization	A length of stay of more than 5 days	post-operative day (POD) 30
Primary	Prolonged ventilation > 24 hours	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	all cause mortality	Patient death, either in hospital or long-term	post-operative day (POD) 30 and 1 year post-op
Secondary	non fatal myocardial infarction	Transmural, Subendocardial infarction	post-operative day (POD) 30 and 1 year post-op
Secondary	Stroke	Transient, permanent	post-operative day (POD) 30
Secondary	Respiratory complications	Pleural effusion, pneumonia	post-operative day (POD) 30
Secondary	Prolonged ICU length of stay	length of stay of more than 48 hours	post-operative day (POD) 30
Secondary	Re-operation for any cause	re-operation due to complications, bleeding and/or other reasons	post-operative day (POD) 30 and 1 year post-op
Secondary	Atrial fibrillation	post-op occurrence requiring treatment	post-operative day (POD) 30 and 1 year post-op
Secondary	Post-operative length of stay and disposition on discharge	home, home with care, transfer to other facility, or expired	post-operative day (POD) 30 and 1 year post-op
Secondary	Wound infection	infection of sternum or other incisional access sites	post-operative day (POD) 30

External Links

•   Related Info