Cardiac Surgery as a Means of Reversing Frailty

Study Overview
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Brief Summary
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Frailty is a multifactorial condition associated with older age, which leads to increased vulnerability to external stressors, such as infections or surgical procedures. Key features of frailty are unintentional weight loss, reduced strength and physical activity as well as the feeling of exhaustion. When selecting patients for surgery, frailty can play an important part in resource planning and prognostication. Multiple studies have shown frailty to have a negative impact on mortality, perioperative adverse events, hospital length of stay as well as postoperative quality of life and functional status. Despite it being an important patient-centered outcome, postoperative quality of life tends to be overlooked when selecting patients for surgery. Cardiac surgery presents a massive stressor to the frail patient, but on the other hand might have the ability to reduce disease burden and improve functional status, thus reducing frailty. This prospective observational cohort study aims to assess frailty, as well as functional status and quality of life in cardiosurgical patients pre- and postoperatively, and evaluate its impact on postoperative clinical and functional outcomes. The primary endpoint of this study is the change in postoperative level of frailty.

Official Title
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Cardiac Surgery as a Means of Reversing Frailty - The CURE-Frailty Trial

Conditions
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Frailty

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age ≥ 60 years elective cardiac surgery Exclusion Criteria: age < 60 years emergency procedures pulmonary thromboendarterectomy declined informed consent pregnant women

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Postoperative Level of Frailty | The Clinical Frailty Scale (CFS) will be used to assess frailty. A CFS of 1 indicates absence of frailty, whereas a CFS of 9 indicates severe frailty. A postoperative change in the CFS indicates a postoperative change in frailty. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life assessed by the SF-12 Patient Questionnaire | Quality of Life will be assessed using the SF-12 Patient Questionnaire. | 12 months | 
| Functional Status assessed by the Functional Independence Measure | Functional status will be assessed using the Functional Independence Measure, with lower scores indicating a worse functional status. | 12 months | 
| 30-day Mortality | Number of participants who have died within 30 days postoperatively. | 30 days | 
| Overall Mortality | Number of participants who have died within the study period. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Frailty, Cardiac Surgery