Cardiac Surgery as a Means of Reversing Frailty

Frailty Clinical Trial

— CURE-Frailty  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04875923
• Other study ID #: 1001/2021
• Status: Completed
• Start date: April 9, 2021
• Est. completion date: September 28, 2022

Study information

• Verified date: March 2024
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 28, 2022
• Est. primary completion date: September 28, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• age = 60 years

• elective cardiac surgery

Exclusion Criteria:

• age < 60 years

• emergency procedures

• pulmonary thromboendarterectomy

• declined informed consent

• pregnant women

Related Conditions & MeSH terms

• Frailty

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Valerie-Anna Rudas

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Quality of Life assessed by the "SF-12 Patient Questionnaire"	Quality of Life will be assessed using the SF-12 Patient Questionnaire.	12 months
Secondary	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
Secondary	30-day Mortality	Number of participants who have died within 30 days postoperatively.	30 days
Secondary	Overall Mortality	Number of participants who have died within the study period.	12 months