Cardiac Surgery as a Means of Reversing Frailty - The CURE-Frailty Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Frailty
- Sponsor
- Dr. Valerie-Anna Rudas
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Change in Postoperative Level of Frailty
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Investigators
Dr. Valerie-Anna Rudas
Resident Dept. of Anesthesia, Critical Care and Pain Medicine
Medical University of Vienna
Eligibility Criteria
Inclusion Criteria
- •age ≥ 60 years
- •elective cardiac surgery
Exclusion Criteria
- •age \< 60 years
- •emergency procedures
- •pulmonary thromboendarterectomy
- •declined informed consent
- •pregnant women
Outcomes
Primary Outcomes
Change in Postoperative Level of Frailty
Time Frame: 12 months
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.
Secondary Outcomes
- Quality of Life assessed by the "SF-12 Patient Questionnaire"(12 months)
- Overall Mortality(12 months)
- 30-day Mortality(30 days)
- Functional Status assessed by the "Functional Independence Measure"(12 months)