Cardiac Surgery as a Means of Reversing Frailty (CURE-Frailty)

March 16, 2024 updated by: Dr. Valerie-Anna Rudas

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Medical University of Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing an elective cardiac surgical intervention

Description

Inclusion Criteria:

  • age ≥ 60 years
  • elective cardiac surgery

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Valerie-Anna Rudas

Investigators

  • Principal Investigator: Martin Bernardi, MD, Medical University of Vienna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 9, 2021

Primary Completion (Actual)

September 28, 2022

Study Completion (Actual)

September 28, 2022

Study Registration Dates

First Submitted

April 21, 2021

First Submitted That Met QC Criteria

May 2, 2021

First Posted (Actual)

May 6, 2021

Study Record Updates

Last Update Posted (Actual)

March 19, 2024

Last Update Submitted That Met QC Criteria

March 16, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1001/2021

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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