Cardiac Surgery as a Means of Reversing Frailty

Completed

• Conditions: Frailty

• Registration Number: NCT04875923
• Lead Sponsor: Dr. Valerie-Anna Rudas

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-09
• Study First Submitted: 2021-04-21
• Study First Submitted QC: 2021-05-02
• Study First Posted: 2021-05-06
• Primary Completion: 2022-09-28
• Study Completion: 2022-09-28
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-16
• Last Update Posted: 2024-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• age ≥ 60 years
• elective cardiac surgery

Exclusion Criteria

• age < 60 years
• emergency procedures
• pulmonary thromboendarterectomy
• declined informed consent
• pregnant women

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Postoperative Level of Frailty	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 Outcome Measures

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

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria