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Cardiac Surgery as a Means of Reversing Frailty

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04875923
Acronym
CURE-Frailty
Enrollment
80
Registered
2021-05-06
Start date
2021-04-09
Completion date
2022-09-28
Last updated
2024-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Frailty

Keywords

Frailty, Cardiac Surgery

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.

Interventions

None listed

Sponsors

Dr. Valerie-Anna Rudas
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* age ≥ 60 years * elective cardiac surgery

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Postoperative Level of Frailty12 monthsThe 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

MeasureTime frameDescription
Quality of Life assessed by the SF-12 Patient Questionnaire12 monthsQuality of Life will be assessed using the SF-12 Patient Questionnaire.
Functional Status assessed by the Functional Independence Measure12 monthsFunctional status will be assessed using the Functional Independence Measure, with lower scores indicating a worse functional status.
30-day Mortality30 daysNumber of participants who have died within 30 days postoperatively.
Overall Mortality12 monthsNumber of participants who have died within the study period.

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 10, 2026