The Impact of Obesity on Postoperative Outcomes Following Cardiac Surgery
OPOS
1 other identifier
observational
610
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2014
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2014
CompletedFirst Submitted
Initial submission to the registry
August 10, 2017
CompletedFirst Posted
Study publicly available on registry
August 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2030
ExpectedJuly 28, 2021
July 1, 2021
11 years
August 10, 2017
July 27, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
Prolonged Hospitalization
A length of stay of more than 5 days
post-operative day (POD) 30
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 Outcomes (9)
all cause mortality
post-operative day (POD) 30 and 1 year post-op
non fatal myocardial infarction
post-operative day (POD) 30 and 1 year post-op
Stroke
post-operative day (POD) 30
Respiratory complications
post-operative day (POD) 30
Prolonged ICU length of stay
post-operative day (POD) 30
- +4 more secondary outcomes
Study Arms (2)
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
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
Interventions
cardiac surgery including non-emergency, elective coronary artery bypass grafting surgery with or without valve surgery, aortic or mitral valve surgery
Eligibility Criteria
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.
You may qualify if:
- · 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cardiovascular Research New Brunswicklead
- Horizon Health Networkcollaborator
- Maritime Heart Centrecollaborator
Study Sites (1)
Saint John Regional Hospital
Saint John, New Brunswick, E2L 4L2, Canada
Related Publications (2)
Aguiar C, MacLeod J, Yip A, Melville S, Legare 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.
PMID: 30833313BACKGROUNDSarkar S, Legere S, Haidl I, Marshall J, MacLeod JB, Aguiar C, Lutchmedial S, Hassan A, Brunt KR, Kienesberger P, Pulinilkunnil T, Legare JF. Serum GDF15, a Promising Biomarker in Obese Patients Undergoing Heart Surgery. Front Cardiovasc Med. 2020 Jun 24;7:103. doi: 10.3389/fcvm.2020.00103. eCollection 2020.
PMID: 32671100DERIVED
Related Links
Biospecimen
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).
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ansar Hassan, MD, PhD
New Brunswick Heart Centre, Department of Cardiac Surgery
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 10, 2017
First Posted
August 15, 2017
Study Start
November 1, 2014
Primary Completion
November 1, 2025
Study Completion (Estimated)
November 1, 2030
Last Updated
July 28, 2021
Record last verified: 2021-07