Cardiac Surgery as a Means of Reversing Frailty

NCT04875923 | Completed

• 1 other identifier: 1001/2021
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Frailty

Keywords

Frailty; Cardiac Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Quality of Life assessed by the "SF-12 Patient Questionnaire"

  12 months

• Functional Status assessed by the "Functional Independence Measure"

  12 months

• 30-day Mortality

  30 days

• Overall Mortality

  12 months

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing an elective cardiac surgical intervention

You may qualify if:

• age ≥ 60 years
• elective cardiac surgery

You may not qualify if:

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

Sponsors & Collaborators

• Dr. Valerie-Anna Rudas: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Martin Bernardi, MD

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Resident Dept. of Anesthesia, Critical Care and Pain Medicine

Study Record Dates

• First Submitted: April 21, 2021
• First Posted: May 6, 2021
• Study Start: April 9, 2021
• Primary Completion: September 28, 2022
• Study Completion: September 28, 2022
• Last Updated: March 19, 2024

Record last verified: 2024-03

Locations

AU (1)