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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03248921
Other study ID # RS#: 2014-2006
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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: - ยท 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 Design


Related Conditions & MeSH terms


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
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