Cardiac Surgery as a Means of Reversing Frailty

NCT ID: NCT04875923

Last Updated: 2024-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-09

Study Completion Date

2022-09-28

Brief Summary

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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

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Conditions

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Frailty

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* age ≥ 60 years
* elective cardiac surgery

Exclusion Criteria

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

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dr. Valerie-Anna Rudas

OTHER

Sponsor Role lead

Responsible Party

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Dr. Valerie-Anna Rudas

Resident Dept. of Anesthesia, Critical Care and Pain Medicine

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Martin Bernardi, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Locations

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Medical University of Vienna

Vienna, , Austria

Site Status

Countries

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Austria

Other Identifiers

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1001/2021

Identifier Type: -

Identifier Source: org_study_id

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