Skip to main content
OpenTrials
Completed

NCT Number: NCT04875923

Cardiac Surgery as a Means of Reversing Frailty

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Frailty Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of Vienna

Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age ≥ 60 years
  • elective cardiac surgery

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. 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

  1. 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.

  2. 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.

  3. 30-day Mortality

    Time frame: 30 days

    Number of participants who have died within 30 days postoperatively.

  4. Overall Mortality

    Time frame: 12 months

    Number of participants who have died within the study period.

Sponsors and collaborators

Lead sponsor

Dr. Valerie-Anna Rudas

Other

Registry information

Official study title

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

Acronym: CURE-Frailty

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 6, 2021
Registry last updated
Mar 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.